GENOTROPIN® Full Patient Information

(somatropin)

Full Patient Information

17 PATIENT COUNSELING INFORMATION

Patients being treated with GENOTROPIN (and/or their parents) should be informed about the potential benefits and risks associated with GENOTROPIN treatment. This information is intended to better educate patients (and caregivers); it is not a disclosure of all possible adverse or intended effects.

Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication.

GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder.

The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12.

Follow the directions for reconstitution provided with each device. Do not shake; shaking may cause denaturation of the active ingredient.

Please see accompanying directions for use of the reconstitution and/or delivery device.

Instructions for Use

INSTRUCTIONS FOR USE
GENOTROPIN 5 (JEEN-o-tro-pin 5)
GENOTROPIN PEN 5 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.

Important Note

Please read these instructions completely before using the GENOTROPIN PEN 5. These instructions need to be followed step by step. Please do not use the GENOTROPIN PEN 5 unless your healthcare provider has trained you.
If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider.

Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider.

GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

•: 1 GENOTROPIN PEN 5 device
•: 1 GENOTROPIN 5 mg single-patient-use 2-chamber cartridge
•: 1 new 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
•: Alcohol swab (not included)
•: 1 sharps disposal container. See "Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5" in Step 14.

Parts of the GENOTROPIN PEN 5 (See Figure A)

Figure A

Storage instructions for your GENOTROPIN PEN 5

•: Between uses, store your pen (with the cartridge) in the refrigerator 36°F to 46°F (2°C to 8°C) in its protective case. Always remove the needle before storing.
•: Do not freeze. Protect from light.
•: Throw away the cartridge within 28 days after mixing, even if the cartridge is not empty.
•: When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put your pen back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 5

Step 1.

Wash your hands well with soap and water before using the GENOTROPIN PEN 5.

Step 2. Attach the Needle • Pull off the front cap (See Figure B).	Figure B
• Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (See Figure C).	Figure C
• Peel off the foil from the needle. • Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (See Figure D). • Do not remove the outer needle cover and inner needle cap until you are ready to inject.	Figure D
Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN Use only the 5 mg cartridge.
• Open the cartridge pack and take out 1 cartridge. • Check that the color on the cartridge matches the color around the window of the plastic body (See Figure E).	Figure E
• Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (See Figure F). • Push the cartridge firmly into place.	Figure F
Step 4. Prepare your Pen • Press the red release button. The injection button will pop up (See Figure G).	Figure G
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go (See Figure H). This will draw back the plunger rod.	Figure H
• Check that the plunger rod is not visible through the plunger rod window (See Figure I). Do not proceed if the plunger rod is visible, as the medicine will not be properly mixed.	Figure I
Step 5. Mix your GENOTROPIN • Make sure that a needle is attached to the metal front part. • While holding your pen upright, gently screw the metal front part and the plastic body back together as shown (See Figure J). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.	Figure J
Step 6. Examine the Solution • Gently tip your pen from side to side to help dissolve the powder completely (See Figure K).	Figure K
• Do not shake your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (See Figure L). • If you see particles, or if the solution is not clear, do not inject. Remove the cartridge and use a new one.	Figure L
Step 7. Release Trapped Air • Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. Do not to touch the exposed needle.
• Remove any trapped air from the solution as follows:
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).	Figure M
b) Hold your pen with the needle pointing upwards. Gently tap the metal front part with your finger to move any air bubbles to the top.
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).	Figure N
d) If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.1'. Repeat steps b) and c) to remove any trapped air from the solution (see Figure O).	Figure O
Step 8. Attach the Needle Guard (Optional) The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.
• Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure P). Do not push the needle guard on the end. Be careful not to touch the exposed needle.	Figure P
My daily dose is mg (write in your daily dose)
Step 9. Dial Your Prescribed Dose • Press the red release button to reset your pen. • The button will pop up and the dose display window will read '0.0'. • Turn the injection button in a clockwise direction (to the right) as shown, until your prescribed dose is displayed (See Figure Q). • If you turn the button too far, turn it back the other way until your correct dose is displayed.	Figure Q
Step 10. Inject your GENOTROPIN • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (see Figure R). • Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas of the skin that have scars or skin problems. • Clean the injection site with the alcohol swab. • Allow the injection site to dry.	Figure R
• Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (See Figure S). • Push the injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (See Figure S).	Figure S
Step 11. Throw away the Needle and Store your GENOTROPIN PEN 5 • Pull off the needle guard, gripping the sides. Be careful not to push on the end. (See Figure T). • Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (See Step 14). Do not reuse the needle. • Push on the front cap, and put your pen back in its protective case. • Store your pen (with the cartridge) in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) until your next injection.	Figure T
Step 12. Your Next Injection If you already have a cartridge in your pen, prepare the pen and give the injection as follows:
• Remove the front cap (See Figure U).	Figure U
• Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure V). • Peel off the foil from a needle.	Figure V
• Push and screw the needle onto the metal front part of the pen as shown (See Figure W). Remove the outer needle cover and inner needle cap. • Follow the instructions above, starting with Step 8: Attach the Needle Guard.	Figure W
Step 13. To Replace the Cartridge • Press the red release button to reset your pen (See Figure X).	Figure X
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (See Figure Y).This will draw back the plunger rod.	Figure Y
• Unscrew the metal front part and remove the empty cartridge (See Figure Z). • Throw away the empty cartridge as instructed by your healthcare provider. • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.	Figure Z

Step 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5
Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and cartridges. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

•: Do not reuse needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Dispose of the entire GENOTROPIN PEN 5 as electronic waste per state and local regulations.

Customizing your Pen

Your pen is supplied with 2 colored clip-on panels, so that you can customize the look of your pen. To remove the clip-on panel from the pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place (See Figure AA).

Figure AA

Caring for your Pen
To clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water or this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad.

Questions and Answers
Question	Answer
How long is the use period of my pen?	The pen has a use period of 2 years starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen?	The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display does not work, can my pen still be used?	Contact your healthcare provider as soon as possible to get a new pen.
What happens if I dial the injection button beyond the maximum dose ('2.0' mg)?	Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.
Why is it difficult to turn or push the injection button?	The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.

Display Information:

	Steady		The selected dose size. The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
	Steady		A dose is not set. The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
	Flashing		The injection button is rotated too fast or too slow. Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		The injection button is rotated too fast or too slow. Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		1 month before the end of the 2 year use period.
	(5 seconds)		This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Pen has reached the end of its use period of 2 years.
			The display will continue to show until the battery is completely empty. This does not indicate a problem with the pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.
	Flashing		Battery charge is low and will be empty in 1 month. Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.
	(5 seconds)
	Steady		Battery power low. The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.
	Steady		Blank screen To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Manufactured by:

Pharmacia & Upjohn Company LLC

A subsidiary of Pfizer Inc.

New York, NY 10001

U.S. License No. 1216

LAB-0225-10.0

Revised August 2024

INSTRUCTIONS FOR USE
GENOTROPIN 12 (JEEN-o-tro-pin 12)
GENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. Use this device only for administration of GENOTROPIN.

Important Note

Please read these instructions completely before using the GENOTROPIN PEN 12. These instructions need to be followed step by step. Please do not use the GENOTROPIN PEN 12 unless your healthcare provider has trained you. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280. If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider.

GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

•: 1 GENOTROPIN PEN 12 device
•: 1 GENOTROPIN 12 mg single-patient-use 2-chamber cartridge
•: 1 new 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
•: Alcohol swab (not included)
•: 1 sharps disposal container. See "Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12" in Step 14.

Parts of the GENOTROPIN PEN 12 (See Figure A)

Figure A

Storage instructions for your GENOTROPIN PEN 12

•: Between uses, store your pen (with the cartridge) in the refrigerator between 36°F to 46°F (2°C to 8°C) in its protective case. Always remove the needle before storing.
•: Do not freeze. Protect from light.
•: Throw away the cartridge within 28 days after mixing, even if the cartridge is not empty.
•: When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put your pen back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 12

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN PEN 12.

Step 2. Attach the Needle • Pull off the front cap (See Figure B).	Figure B
• Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (See Figure C).	Figure C
• Peel off the foil from the needle. • Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (See Figure D). • Do not remove the outer needle cover and inner needle cap until you are ready to inject.	Figure D
Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN Use only the 12 mg cartridge. • Open the cartridge pack and take out 1 cartridge. • Check that the color on the cartridge matches the color around the window of the plastic body (See Figure E).	Figure E
• Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (See Figure F). • Push the cartridge firmly into place.	Figure F
Step 4. Prepare the Pen • Press the red release button. The injection button will pop up (See Figure G).	Figure G
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go (See Figure H). This will draw back the plunger rod.	Figure H
• Check that the plunger rod is not visible through the plunger rod window (See Figure I). Do not proceed if the plunger rod is visible, as the medicine will not be properly mixed.	Figure I
Step 5. Mix your GENOTROPIN • Make sure that a needle is attached to the metal front part. • While holding your pen upright, gently screw the metal front part and the plastic body back together as shown (See Figure J). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.	Figure J
Step 6. Examine the Solution • Gently tip the pen from side to side to help dissolve the powder completely (See Figure K).	Figure K
• Do not shake your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (See Figure L). If you see particles, or if the solution is not clear, do not inject. Remove the cartridge and use a new one.	Figure L
Step 7. Release Trapped Air • Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. Do not touch the exposed needle.
• Remove any trapped air from the solution as follows:
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).	Figure M
b) Hold your pen with the needle pointing upwards (See Figure N). Gently tap the metal front part with your finger to move any air bubbles to the top.	Figure N
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).	Figure N
d) If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.2'. Repeat steps b) and c) to remove any trapped air from the solution (See Figure O).	Figure O
Step 8. Attach the Needle Guard (Optional) The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.
• Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure P). Do not push the needle guard on the end. Be careful not to touch the exposed needle.	Figure P
My daily dose is mg (write in your daily dose)
Step 9. Dial Your Prescribed Dose • Press the red release button to reset your pen. • The button will pop up and the dose display window will read '0.0'. • Turn the injection button in a clockwise direction (to the right) as shown until your prescribed dose is displayed (See Figure Q). • If you turn the button too far, turn it back the other way until your correct dose is displayed.	Figure Q
Step 10. Inject your GENOTROPIN • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (See Figure R). • Avoid areas that are bony, bruised, red, sore or hard, and areas of the skin that have scars or skin conditions. • Clean the injection site with the alcohol swab. • Allow the injection site to dry.	Figure R
• Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (See Figure S). • Push the injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (See Figure S).	Figure S
Step 11. Throw away the Needle and Store the GENOTROPIN PEN 12 • Pull off the needle guard, gripping the sides. Be careful not to push on the end (See Figure T). • Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (See Step 14). Do not reuse the needle. • Push on the front cap, and put your pen back in its protective case. • Store your pen (with the cartridge) in the refrigerator between 36°F to 46°F (2°C to 8°C) until your next injection.	Figure T
Step 12. Your Next Injection If you already have a cartridge in your pen, prepare the pen and give the injection as follows: • Remove the front cap (See Figure U).	Figure U
• Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure V). • Peel off the foil from a needle.	Figure V
• Push and screw the needle onto the metal front part of your pen as shown (See Figure W). Remove the outer needle cover and inner needle cap. • Follow the instructions above, starting with Step 8: Attach the Needle Guard.	Figure W
Step 13. To Replace the Cartridge • Press the red release button to reset your pen (See Figure X).	Figure X
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (See Figure Y). This will draw back the plunger rod.	Figure Y
• Unscrew the metal front part and remove the empty cartridge (See Figure Z). • Throw away the empty cartridge as instructed by your healthcare provider. • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.	Figure Z

Step 14. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12
Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

•: Do not reuse needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Dispose of the entire GENOTROPIN PEN 12 as electronic waste per state and local regulations.

Customizing your Pen
Your pen is supplied with 2 colored clip-on panels, so that you can customize the look of your pen. To remove the clip-on panel from your pen, insert the lip of the front cap into the groove under the front end of the panel, and pry the panel off. The new panel simply clicks into place (See Figure AA).

Figure AA

Caring for your Pen

To clean your pen, wipe the outside surface with a damp cloth. Do not put the pen in water as this may damage your pen. Do not use alcohol or any other cleaning agents to clean the pen, as they may damage the plastic body. To clean the needle guard, wipe it with a damp cloth or alcohol pad.

Questions and Answers
Question	Answer
How long is the use period of my pen?	The pen has a use period of 2 years starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen?	The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further, the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display does not work, can my pen still be used?	Contact your healthcare provider as soon as possible to get a new pen.
What happens if I dial the injection button beyond the maximum dose ('4.0' mg)?	Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.
Why is it difficult to turn or push the injection button?	The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.

Display Information

	Steady		The selected dose size. The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
	Steady		A dose is not set. The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
	Flashing		The injection button is rotated too fast or too slow. Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		The injection button is rotated too fast or too slow. Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		1 month before the end of the 2 year use period.
	(5 seconds)		This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Pen has reached the end of its use period of 2 years.
			The display will continue to show until the battery is completely empty. This does not indicate a problem with your pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.
	Flashing		Battery charge is low and will be empty in 1 month.
	(5 seconds)		Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Battery power low. The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.
	Steady		Blank screen To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery.

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Caution: Federal law restricts this device to sale by or on the order of a physician.

Manufactured by:
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc.
New York, NY 10001
U.S. License No. 1216

LAB-0224-10.0

Revised August 2024

INSTRUCTIONS FOR USE
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing GENOTROPIN (somatropin) for injection

Important Note

Please read these instructions completely before using GENOTROPIN MINIQUICK. If there is anything you do not understand or cannot do, call the Pfizer Bridge Program toll-free number at 1-800-645-1280.

GENOTROPIN MINIQUICK is available in 10 dose strengths. Check your GENOTROPIN MINIQUICK to be sure you have the dose your healthcare provider prescribed.

GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.

For each injection you will need:

•: 2 alcohol pads (not included)
•: 1 GENOTROPIN MINIQUICK device with the single‑dose 2-chamber cartridge of GENOTROPIN inside. The 2-chamber cartridge of GENOTROPIN contains the growth hormone powder in one chamber and the liquid in the other.
•: 1 injection needle. A needle for injection is provided with each device. If you need additional needles, ask your healthcare provider for a 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle.
•: 1 sharps disposal container (not included). See "Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles" in Step 12.

Parts of the GENOTROPIN MINIQUICK (See Figure A)

Storage instructions for your GENOTROPIN MINIQUICK

•: Keep your GENOTROPIN MINIQUICK in the original carton to protect it from light.
•: Before you mix the growth hormone powder with the liquid in the syringe, you can store the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). You can also store the GENOTROPIN MINIQUICK at room temperature between 68ºF to 77ºF (20ºC to 25ºC) for up to 3 months. Do not freeze.
•: Inject the GENOTROPIN right after you mix it. If that is not possible, you can keep the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours after mixing it. Do not freeze.

Using your GENOTROPIN MINIQUICK

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN MINIQUICK.

Step 2.
Open the plastic bag that contains your GENOTROPIN MINIQUICK by tearing the bag along the dotted lines on the plastic.

Step 3. Wipe the rubber stopper on the GENOTROPIN MINIQUICK with an alcohol pad. (See Figure B)	Figure B
Step 4. Peel the seal from the back of the injection needle. Leave both the inner needle cover and the outer needle cover on the needle. (See Figure C)	Figure C
Step 5. • Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn. • Make sure the needle is placed directly over the rubber stopper (not at an angle), before screwing the needle onto the rubber stopper of the GENOTROPIN MINIQUICK. (See Figure D)	Figure D
Step 6. • Hold the GENOTROPIN MINIQUICK with the needle pointing up. Turn the plunger rod clockwise (to the right) until it will not go any further. (See Figure E) This will automatically mix the growth hormone powder and the liquid. • Do not shake the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well. • Make sure the solution (combined growth hormone powder and liquid) is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, do not inject it. Call the Pfizer Bridge Program at 1-800-645-1280.	Figure E
Step 7. • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be at least 1 inch from the site you used before (See Figure F). Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas that have scars or skin problems. • Clean the injection site with the alcohol swab. Allow the injection site to dry.	Figure F
Step 8. • Remove the outer needle cover and the inner needle cover from the needle. Save the outer needle cover. (See Figure G)	Figure G
Step 9. • Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. (See Figure H)	Figure H
Step 10. • Push the plunger rod in as far as it will go, to inject all of the medicine in the GENOTROPIN MINIQUICK into the fold of skin. (See Figure I) • Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.	Figure I
Step 11 • Replace the outer needle cover on the needle. (See Figure J)	Figure J

Step 12. Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles

Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

•: Do not reuse the GENOTROPIN MINIQUICK or needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Questions and Answers
Question	Answer
Is it a problem if I see air bubbles in the syringe?	No. There is no need to remove the air bubbles from the GENOTROPIN MINIQUICK. The small amount of air in the syringe does not affect your injection.
What should I do if I have problems turning the plunger rod (Step 6)?	The problem could be because the needle has been inserted at an angle onto the rubber stopper. Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.
What should I do if I have problems pushing the plunger when making the injection (Step 10)?	The problem could be because the needle has been inserted at an angle onto the rubber stopper. Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.
What should I do if the needle is damaged or bent?	Throw away the needle and use a new needle with the GENOTROPIN MINIQUICK. See "Disposing of (throwing away) your GENOTROPIN MINIQUICK and needles".

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc.
New York, NY 10001

U.S. License No. 1216
Logo

LAB-0227-9.0
Revised: August 2024

Find GENOTROPIN® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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Full Patient Information

17 PATIENT COUNSELING INFORMATION

GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder.

Follow the directions for reconstitution provided with each device. Do not shake; shaking may cause denaturation of the active ingredient.

Please see accompanying directions for use of the reconstitution and/or delivery device.

Instructions for Use

Important Note

GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

•: 1 GENOTROPIN PEN 5 device
•: 1 GENOTROPIN 5 mg single-patient-use 2-chamber cartridge
•: 1 new 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
•: Alcohol swab (not included)
•: 1 sharps disposal container. See "Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5" in Step 14.

Parts of the GENOTROPIN PEN 5 (See Figure A)

Figure A

Storage instructions for your GENOTROPIN PEN 5

•: Between uses, store your pen (with the cartridge) in the refrigerator 36°F to 46°F (2°C to 8°C) in its protective case. Always remove the needle before storing.
•: Do not freeze. Protect from light.
•: Throw away the cartridge within 28 days after mixing, even if the cartridge is not empty.
•: When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put your pen back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 5

Step 1.

Wash your hands well with soap and water before using the GENOTROPIN PEN 5.

Step 2. Attach the Needle • Pull off the front cap (See Figure B).	Figure B
• Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (See Figure C).	Figure C
• Peel off the foil from the needle. • Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (See Figure D). • Do not remove the outer needle cover and inner needle cap until you are ready to inject.	Figure D
Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN Use only the 5 mg cartridge.
• Open the cartridge pack and take out 1 cartridge. • Check that the color on the cartridge matches the color around the window of the plastic body (See Figure E).	Figure E
• Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (See Figure F). • Push the cartridge firmly into place.	Figure F
Step 4. Prepare your Pen • Press the red release button. The injection button will pop up (See Figure G).	Figure G
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go (See Figure H). This will draw back the plunger rod.	Figure H
• Check that the plunger rod is not visible through the plunger rod window (See Figure I). Do not proceed if the plunger rod is visible, as the medicine will not be properly mixed.	Figure I
Step 5. Mix your GENOTROPIN • Make sure that a needle is attached to the metal front part. • While holding your pen upright, gently screw the metal front part and the plastic body back together as shown (See Figure J). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.	Figure J
Step 6. Examine the Solution • Gently tip your pen from side to side to help dissolve the powder completely (See Figure K).	Figure K
• Do not shake your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (See Figure L). • If you see particles, or if the solution is not clear, do not inject. Remove the cartridge and use a new one.	Figure L
Step 7. Release Trapped Air • Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. Do not to touch the exposed needle.
• Remove any trapped air from the solution as follows:
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).	Figure M
b) Hold your pen with the needle pointing upwards. Gently tap the metal front part with your finger to move any air bubbles to the top.
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).	Figure N
d) If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.1'. Repeat steps b) and c) to remove any trapped air from the solution (see Figure O).	Figure O
Step 8. Attach the Needle Guard (Optional) The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.
• Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure P). Do not push the needle guard on the end. Be careful not to touch the exposed needle.	Figure P
My daily dose is mg (write in your daily dose)
Step 9. Dial Your Prescribed Dose • Press the red release button to reset your pen. • The button will pop up and the dose display window will read '0.0'. • Turn the injection button in a clockwise direction (to the right) as shown, until your prescribed dose is displayed (See Figure Q). • If you turn the button too far, turn it back the other way until your correct dose is displayed.	Figure Q
Step 10. Inject your GENOTROPIN • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (see Figure R). • Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas of the skin that have scars or skin problems. • Clean the injection site with the alcohol swab. • Allow the injection site to dry.	Figure R
• Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (See Figure S). • Push the injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (See Figure S).	Figure S
Step 11. Throw away the Needle and Store your GENOTROPIN PEN 5 • Pull off the needle guard, gripping the sides. Be careful not to push on the end. (See Figure T). • Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (See Step 14). Do not reuse the needle. • Push on the front cap, and put your pen back in its protective case. • Store your pen (with the cartridge) in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) until your next injection.	Figure T
Step 12. Your Next Injection If you already have a cartridge in your pen, prepare the pen and give the injection as follows:
• Remove the front cap (See Figure U).	Figure U
• Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure V). • Peel off the foil from a needle.	Figure V
• Push and screw the needle onto the metal front part of the pen as shown (See Figure W). Remove the outer needle cover and inner needle cap. • Follow the instructions above, starting with Step 8: Attach the Needle Guard.	Figure W
Step 13. To Replace the Cartridge • Press the red release button to reset your pen (See Figure X).	Figure X
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (See Figure Y).This will draw back the plunger rod.	Figure Y
• Unscrew the metal front part and remove the empty cartridge (See Figure Z). • Throw away the empty cartridge as instructed by your healthcare provider. • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.	Figure Z

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

•: Do not reuse needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Dispose of the entire GENOTROPIN PEN 5 as electronic waste per state and local regulations.

Customizing your Pen

Figure AA

Questions and Answers
Question	Answer
How long is the use period of my pen?	The pen has a use period of 2 years starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen?	The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display does not work, can my pen still be used?	Contact your healthcare provider as soon as possible to get a new pen.
What happens if I dial the injection button beyond the maximum dose ('2.0' mg)?	Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.
Why is it difficult to turn or push the injection button?	The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.

Display Information:

	Steady		The selected dose size. The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
	Steady		A dose is not set. The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
	Flashing		The injection button is rotated too fast or too slow. Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		The injection button is rotated too fast or too slow. Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		1 month before the end of the 2 year use period.
	(5 seconds)		This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Pen has reached the end of its use period of 2 years.
			The display will continue to show until the battery is completely empty. This does not indicate a problem with the pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.
	Flashing		Battery charge is low and will be empty in 1 month. Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.
	(5 seconds)
	Steady		Battery power low. The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.
	Steady		Blank screen To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Manufactured by:

Pharmacia & Upjohn Company LLC

A subsidiary of Pfizer Inc.

New York, NY 10001

U.S. License No. 1216

LAB-0225-10.0

Revised August 2024

Important Note

GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

•: 1 GENOTROPIN PEN 12 device
•: 1 GENOTROPIN 12 mg single-patient-use 2-chamber cartridge
•: 1 new 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
•: Alcohol swab (not included)
•: 1 sharps disposal container. See "Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12" in Step 14.

Parts of the GENOTROPIN PEN 12 (See Figure A)

Figure A

Storage instructions for your GENOTROPIN PEN 12

•: Between uses, store your pen (with the cartridge) in the refrigerator between 36°F to 46°F (2°C to 8°C) in its protective case. Always remove the needle before storing.
•: Do not freeze. Protect from light.
•: Throw away the cartridge within 28 days after mixing, even if the cartridge is not empty.
•: When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put your pen back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 12

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN PEN 12.

Step 2. Attach the Needle • Pull off the front cap (See Figure B).	Figure B
• Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (See Figure C).	Figure C
• Peel off the foil from the needle. • Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (See Figure D). • Do not remove the outer needle cover and inner needle cap until you are ready to inject.	Figure D
Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN Use only the 12 mg cartridge. • Open the cartridge pack and take out 1 cartridge. • Check that the color on the cartridge matches the color around the window of the plastic body (See Figure E).	Figure E
• Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (See Figure F). • Push the cartridge firmly into place.	Figure F
Step 4. Prepare the Pen • Press the red release button. The injection button will pop up (See Figure G).	Figure G
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go (See Figure H). This will draw back the plunger rod.	Figure H
• Check that the plunger rod is not visible through the plunger rod window (See Figure I). Do not proceed if the plunger rod is visible, as the medicine will not be properly mixed.	Figure I
Step 5. Mix your GENOTROPIN • Make sure that a needle is attached to the metal front part. • While holding your pen upright, gently screw the metal front part and the plastic body back together as shown (See Figure J). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.	Figure J
Step 6. Examine the Solution • Gently tip the pen from side to side to help dissolve the powder completely (See Figure K).	Figure K
• Do not shake your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (See Figure L). If you see particles, or if the solution is not clear, do not inject. Remove the cartridge and use a new one.	Figure L
Step 7. Release Trapped Air • Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. Do not touch the exposed needle.
• Remove any trapped air from the solution as follows:
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).	Figure M
b) Hold your pen with the needle pointing upwards (See Figure N). Gently tap the metal front part with your finger to move any air bubbles to the top.	Figure N
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).	Figure N
d) If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.2'. Repeat steps b) and c) to remove any trapped air from the solution (See Figure O).	Figure O
Step 8. Attach the Needle Guard (Optional) The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.
• Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure P). Do not push the needle guard on the end. Be careful not to touch the exposed needle.	Figure P
My daily dose is mg (write in your daily dose)
Step 9. Dial Your Prescribed Dose • Press the red release button to reset your pen. • The button will pop up and the dose display window will read '0.0'. • Turn the injection button in a clockwise direction (to the right) as shown until your prescribed dose is displayed (See Figure Q). • If you turn the button too far, turn it back the other way until your correct dose is displayed.	Figure Q
Step 10. Inject your GENOTROPIN • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (See Figure R). • Avoid areas that are bony, bruised, red, sore or hard, and areas of the skin that have scars or skin conditions. • Clean the injection site with the alcohol swab. • Allow the injection site to dry.	Figure R
• Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (See Figure S). • Push the injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (See Figure S).	Figure S
Step 11. Throw away the Needle and Store the GENOTROPIN PEN 12 • Pull off the needle guard, gripping the sides. Be careful not to push on the end (See Figure T). • Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (See Step 14). Do not reuse the needle. • Push on the front cap, and put your pen back in its protective case. • Store your pen (with the cartridge) in the refrigerator between 36°F to 46°F (2°C to 8°C) until your next injection.	Figure T
Step 12. Your Next Injection If you already have a cartridge in your pen, prepare the pen and give the injection as follows: • Remove the front cap (See Figure U).	Figure U
• Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure V). • Peel off the foil from a needle.	Figure V
• Push and screw the needle onto the metal front part of your pen as shown (See Figure W). Remove the outer needle cover and inner needle cap. • Follow the instructions above, starting with Step 8: Attach the Needle Guard.	Figure W
Step 13. To Replace the Cartridge • Press the red release button to reset your pen (See Figure X).	Figure X
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (See Figure Y). This will draw back the plunger rod.	Figure Y
• Unscrew the metal front part and remove the empty cartridge (See Figure Z). • Throw away the empty cartridge as instructed by your healthcare provider. • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.	Figure Z

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

•: Do not reuse needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Dispose of the entire GENOTROPIN PEN 12 as electronic waste per state and local regulations.

Figure AA

Caring for your Pen

Questions and Answers
Question	Answer
How long is the use period of my pen?	The pen has a use period of 2 years starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen?	The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further, the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display does not work, can my pen still be used?	Contact your healthcare provider as soon as possible to get a new pen.
What happens if I dial the injection button beyond the maximum dose ('4.0' mg)?	Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.
Why is it difficult to turn or push the injection button?	The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.

Display Information

	Steady		The selected dose size. The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
	Steady		A dose is not set. The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
	Flashing		The injection button is rotated too fast or too slow. Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		The injection button is rotated too fast or too slow. Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		1 month before the end of the 2 year use period.
	(5 seconds)		This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Pen has reached the end of its use period of 2 years.
			The display will continue to show until the battery is completely empty. This does not indicate a problem with your pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.
	Flashing		Battery charge is low and will be empty in 1 month.
	(5 seconds)		Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Battery power low. The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.
	Steady		Blank screen To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery.

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Caution: Federal law restricts this device to sale by or on the order of a physician.

Manufactured by:
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc.
New York, NY 10001
U.S. License No. 1216

LAB-0224-10.0

Revised August 2024

INSTRUCTIONS FOR USE
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing GENOTROPIN (somatropin) for injection

Important Note

GENOTROPIN MINIQUICK is available in 10 dose strengths. Check your GENOTROPIN MINIQUICK to be sure you have the dose your healthcare provider prescribed.

GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.

For each injection you will need:

•: 2 alcohol pads (not included)
•: 1 GENOTROPIN MINIQUICK device with the single‑dose 2-chamber cartridge of GENOTROPIN inside. The 2-chamber cartridge of GENOTROPIN contains the growth hormone powder in one chamber and the liquid in the other.
•: 1 injection needle. A needle for injection is provided with each device. If you need additional needles, ask your healthcare provider for a 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle.
•: 1 sharps disposal container (not included). See "Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles" in Step 12.

Parts of the GENOTROPIN MINIQUICK (See Figure A)

Storage instructions for your GENOTROPIN MINIQUICK

•: Keep your GENOTROPIN MINIQUICK in the original carton to protect it from light.
•: Before you mix the growth hormone powder with the liquid in the syringe, you can store the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). You can also store the GENOTROPIN MINIQUICK at room temperature between 68ºF to 77ºF (20ºC to 25ºC) for up to 3 months. Do not freeze.
•: Inject the GENOTROPIN right after you mix it. If that is not possible, you can keep the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours after mixing it. Do not freeze.

Using your GENOTROPIN MINIQUICK

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN MINIQUICK.

Step 2.
Open the plastic bag that contains your GENOTROPIN MINIQUICK by tearing the bag along the dotted lines on the plastic.

Step 3. Wipe the rubber stopper on the GENOTROPIN MINIQUICK with an alcohol pad. (See Figure B)	Figure B
Step 4. Peel the seal from the back of the injection needle. Leave both the inner needle cover and the outer needle cover on the needle. (See Figure C)	Figure C
Step 5. • Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn. • Make sure the needle is placed directly over the rubber stopper (not at an angle), before screwing the needle onto the rubber stopper of the GENOTROPIN MINIQUICK. (See Figure D)	Figure D
Step 6. • Hold the GENOTROPIN MINIQUICK with the needle pointing up. Turn the plunger rod clockwise (to the right) until it will not go any further. (See Figure E) This will automatically mix the growth hormone powder and the liquid. • Do not shake the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well. • Make sure the solution (combined growth hormone powder and liquid) is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, do not inject it. Call the Pfizer Bridge Program at 1-800-645-1280.	Figure E
Step 7. • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be at least 1 inch from the site you used before (See Figure F). Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas that have scars or skin problems. • Clean the injection site with the alcohol swab. Allow the injection site to dry.	Figure F
Step 8. • Remove the outer needle cover and the inner needle cover from the needle. Save the outer needle cover. (See Figure G)	Figure G
Step 9. • Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. (See Figure H)	Figure H
Step 10. • Push the plunger rod in as far as it will go, to inject all of the medicine in the GENOTROPIN MINIQUICK into the fold of skin. (See Figure I) • Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.	Figure I
Step 11 • Replace the outer needle cover on the needle. (See Figure J)	Figure J

Step 12. Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles

Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

•: Do not reuse the GENOTROPIN MINIQUICK or needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Questions and Answers
Question	Answer
Is it a problem if I see air bubbles in the syringe?	No. There is no need to remove the air bubbles from the GENOTROPIN MINIQUICK. The small amount of air in the syringe does not affect your injection.
What should I do if I have problems turning the plunger rod (Step 6)?	The problem could be because the needle has been inserted at an angle onto the rubber stopper. Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.
What should I do if I have problems pushing the plunger when making the injection (Step 10)?	The problem could be because the needle has been inserted at an angle onto the rubber stopper. Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.
What should I do if the needle is damaged or bent?	Throw away the needle and use a new needle with the GENOTROPIN MINIQUICK. See "Disposing of (throwing away) your GENOTROPIN MINIQUICK and needles".

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc.
New York, NY 10001

U.S. License No. 1216
Logo

LAB-0227-9.0
Revised: August 2024

Prescribing Information

Download Prescribing Information

Health Professional Information

Full Patient Information

17 PATIENT COUNSELING INFORMATION

GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. A reconstitution device is used to mix the diluent and powder.

Follow the directions for reconstitution provided with each device. Do not shake; shaking may cause denaturation of the active ingredient.

Please see accompanying directions for use of the reconstitution and/or delivery device.

Instructions for Use

Important Note

GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

•: 1 GENOTROPIN PEN 5 device
•: 1 GENOTROPIN 5 mg single-patient-use 2-chamber cartridge
•: 1 new 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
•: Alcohol swab (not included)
•: 1 sharps disposal container. See "Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5" in Step 14.

Parts of the GENOTROPIN PEN 5 (See Figure A)

Figure A

Storage instructions for your GENOTROPIN PEN 5

•: Between uses, store your pen (with the cartridge) in the refrigerator 36°F to 46°F (2°C to 8°C) in its protective case. Always remove the needle before storing.
•: Do not freeze. Protect from light.
•: Throw away the cartridge within 28 days after mixing, even if the cartridge is not empty.
•: When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put your pen back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 5

Step 1.

Wash your hands well with soap and water before using the GENOTROPIN PEN 5.

Step 2. Attach the Needle • Pull off the front cap (See Figure B).	Figure B
• Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (See Figure C).	Figure C
• Peel off the foil from the needle. • Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (See Figure D). • Do not remove the outer needle cover and inner needle cap until you are ready to inject.	Figure D
Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN Use only the 5 mg cartridge.
• Open the cartridge pack and take out 1 cartridge. • Check that the color on the cartridge matches the color around the window of the plastic body (See Figure E).	Figure E
• Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (See Figure F). • Push the cartridge firmly into place.	Figure F
Step 4. Prepare your Pen • Press the red release button. The injection button will pop up (See Figure G).	Figure G
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go (See Figure H). This will draw back the plunger rod.	Figure H
• Check that the plunger rod is not visible through the plunger rod window (See Figure I). Do not proceed if the plunger rod is visible, as the medicine will not be properly mixed.	Figure I
Step 5. Mix your GENOTROPIN • Make sure that a needle is attached to the metal front part. • While holding your pen upright, gently screw the metal front part and the plastic body back together as shown (See Figure J). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.	Figure J
Step 6. Examine the Solution • Gently tip your pen from side to side to help dissolve the powder completely (See Figure K).	Figure K
• Do not shake your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (See Figure L). • If you see particles, or if the solution is not clear, do not inject. Remove the cartridge and use a new one.	Figure L
Step 7. Release Trapped Air • Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. Do not to touch the exposed needle.
• Remove any trapped air from the solution as follows:
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).	Figure M
b) Hold your pen with the needle pointing upwards. Gently tap the metal front part with your finger to move any air bubbles to the top.
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).	Figure N
d) If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.1'. Repeat steps b) and c) to remove any trapped air from the solution (see Figure O).	Figure O
Step 8. Attach the Needle Guard (Optional) The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.
• Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure P). Do not push the needle guard on the end. Be careful not to touch the exposed needle.	Figure P
My daily dose is mg (write in your daily dose)
Step 9. Dial Your Prescribed Dose • Press the red release button to reset your pen. • The button will pop up and the dose display window will read '0.0'. • Turn the injection button in a clockwise direction (to the right) as shown, until your prescribed dose is displayed (See Figure Q). • If you turn the button too far, turn it back the other way until your correct dose is displayed.	Figure Q
Step 10. Inject your GENOTROPIN • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (see Figure R). • Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas of the skin that have scars or skin problems. • Clean the injection site with the alcohol swab. • Allow the injection site to dry.	Figure R
• Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (See Figure S). • Push the injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (See Figure S).	Figure S
Step 11. Throw away the Needle and Store your GENOTROPIN PEN 5 • Pull off the needle guard, gripping the sides. Be careful not to push on the end. (See Figure T). • Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (See Step 14). Do not reuse the needle. • Push on the front cap, and put your pen back in its protective case. • Store your pen (with the cartridge) in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) until your next injection.	Figure T
Step 12. Your Next Injection If you already have a cartridge in your pen, prepare the pen and give the injection as follows:
• Remove the front cap (See Figure U).	Figure U
• Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure V). • Peel off the foil from a needle.	Figure V
• Push and screw the needle onto the metal front part of the pen as shown (See Figure W). Remove the outer needle cover and inner needle cap. • Follow the instructions above, starting with Step 8: Attach the Needle Guard.	Figure W
Step 13. To Replace the Cartridge • Press the red release button to reset your pen (See Figure X).	Figure X
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (See Figure Y).This will draw back the plunger rod.	Figure Y
• Unscrew the metal front part and remove the empty cartridge (See Figure Z). • Throw away the empty cartridge as instructed by your healthcare provider. • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.	Figure Z

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

•: Do not reuse needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Dispose of the entire GENOTROPIN PEN 5 as electronic waste per state and local regulations.

Customizing your Pen

Figure AA

Questions and Answers
Question	Answer
How long is the use period of my pen?	The pen has a use period of 2 years starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen?	The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display does not work, can my pen still be used?	Contact your healthcare provider as soon as possible to get a new pen.
What happens if I dial the injection button beyond the maximum dose ('2.0' mg)?	Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.
Why is it difficult to turn or push the injection button?	The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.

Display Information:

	Steady		The selected dose size. The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
	Steady		A dose is not set. The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
	Flashing		The injection button is rotated too fast or too slow. Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		The injection button is rotated too fast or too slow. Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		1 month before the end of the 2 year use period.
	(5 seconds)		This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Pen has reached the end of its use period of 2 years.
			The display will continue to show until the battery is completely empty. This does not indicate a problem with the pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.
	Flashing		Battery charge is low and will be empty in 1 month. Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.
	(5 seconds)
	Steady		Battery power low. The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.
	Steady		Blank screen To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Manufactured by:

Pharmacia & Upjohn Company LLC

A subsidiary of Pfizer Inc.

New York, NY 10001

U.S. License No. 1216

LAB-0225-10.0

Revised August 2024

Important Note

GENOTROPIN PEN 12 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.

For your injection you will need:

•: 1 GENOTROPIN PEN 12 device
•: 1 GENOTROPIN 12 mg single-patient-use 2-chamber cartridge
•: 1 new 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle
•: Alcohol swab (not included)
•: 1 sharps disposal container. See "Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12" in Step 14.

Parts of the GENOTROPIN PEN 12 (See Figure A)

Figure A

Storage instructions for your GENOTROPIN PEN 12

•: Between uses, store your pen (with the cartridge) in the refrigerator between 36°F to 46°F (2°C to 8°C) in its protective case. Always remove the needle before storing.
•: Do not freeze. Protect from light.
•: Throw away the cartridge within 28 days after mixing, even if the cartridge is not empty.
•: When travelling, keep your pen in its protective case and carry it in an insulated bag to protect it from heat or freezing. Put your pen back in the refrigerator as soon as possible.

Using your GENOTROPIN PEN 12

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN PEN 12.

Step 2. Attach the Needle • Pull off the front cap (See Figure B).	Figure B
• Unscrew the metal front part from the plastic body by turning the metal front part clockwise (to the right) (See Figure C).	Figure C
• Peel off the foil from the needle. • Push and screw the needle onto the metal front part using the outer needle cover, by turning it counter clockwise (to the left) (See Figure D). • Do not remove the outer needle cover and inner needle cap until you are ready to inject.	Figure D
Step 3. Insert the 2-Chamber Cartridge of GENOTROPIN Use only the 12 mg cartridge. • Open the cartridge pack and take out 1 cartridge. • Check that the color on the cartridge matches the color around the window of the plastic body (See Figure E).	Figure E
• Hold the metal front part upright, and insert the cartridge. Insert the end of the cartridge with the metal cap first, as shown (See Figure F). • Push the cartridge firmly into place.	Figure F
Step 4. Prepare the Pen • Press the red release button. The injection button will pop up (See Figure G).	Figure G
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go (See Figure H). This will draw back the plunger rod.	Figure H
• Check that the plunger rod is not visible through the plunger rod window (See Figure I). Do not proceed if the plunger rod is visible, as the medicine will not be properly mixed.	Figure I
Step 5. Mix your GENOTROPIN • Make sure that a needle is attached to the metal front part. • While holding your pen upright, gently screw the metal front part and the plastic body back together as shown (See Figure J). Make sure that the metal front part is firmly attached to the plastic body. This mixes the liquid and the powder.	Figure J
Step 6. Examine the Solution • Gently tip the pen from side to side to help dissolve the powder completely (See Figure K).	Figure K
• Do not shake your pen, as this might stop the growth hormone from working. Check that the solution (combined growth hormone powder and liquid) is clear in the cartridge window (See Figure L). If you see particles, or if the solution is not clear, do not inject. Remove the cartridge and use a new one.	Figure L
Step 7. Release Trapped Air • Remove both the outer needle cover and inner needle cap. Throw away (dispose of) both the inner needle cap and outer needle cover. Do not touch the exposed needle.
• Remove any trapped air from the solution as follows:
a) Turn the injection button so that the white mark on the injection button lines up with the black mark on the plastic body (See Figure M).	Figure M
b) Hold your pen with the needle pointing upwards (See Figure N). Gently tap the metal front part with your finger to move any air bubbles to the top.	Figure N
c) Push the injection button all the way in. You will see a drop of liquid appear at the needle tip. Any trapped air has now been released (See Figure N).	Figure N
d) If you do not see liquid at the needle tip, press the red release button. Then turn the injection button in the direction of the arrow until it clicks 1 time, and the dose display shows '0.2'. Repeat steps b) and c) to remove any trapped air from the solution (See Figure O).	Figure O
Step 8. Attach the Needle Guard (Optional) The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. You can choose to use the needle guard, if desired.
• Grip the sides of the needle guard. Push it over the needle until it snaps in place (See Figure P). Do not push the needle guard on the end. Be careful not to touch the exposed needle.	Figure P
My daily dose is mg (write in your daily dose)
Step 9. Dial Your Prescribed Dose • Press the red release button to reset your pen. • The button will pop up and the dose display window will read '0.0'. • Turn the injection button in a clockwise direction (to the right) as shown until your prescribed dose is displayed (See Figure Q). • If you turn the button too far, turn it back the other way until your correct dose is displayed.	Figure Q
Step 10. Inject your GENOTROPIN • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be given at least 1 inch from the site you used before (See Figure R). • Avoid areas that are bony, bruised, red, sore or hard, and areas of the skin that have scars or skin conditions. • Clean the injection site with the alcohol swab. • Allow the injection site to dry.	Figure R
• Firmly pinch a fold of skin at the injection area. Push the needle fully into the skin fold at a 90° angle as shown (See Figure S). • Push the injection button until it clicks. Wait while counting slowly for 5 seconds, and then remove the needle from the skin. This is to make sure that the entire dose has been injected (See Figure S).	Figure S
Step 11. Throw away the Needle and Store the GENOTROPIN PEN 12 • Pull off the needle guard, gripping the sides. Be careful not to push on the end (See Figure T). • Remove the needle as instructed by your healthcare provider, and throw it away in a sharps disposal container (See Step 14). Do not reuse the needle. • Push on the front cap, and put your pen back in its protective case. • Store your pen (with the cartridge) in the refrigerator between 36°F to 46°F (2°C to 8°C) until your next injection.	Figure T
Step 12. Your Next Injection If you already have a cartridge in your pen, prepare the pen and give the injection as follows: • Remove the front cap (See Figure U).	Figure U
• Make sure there is enough growth hormone solution in the cartridge for your dose. Check the position of the plunger against the indicative scale in the cartridge window (See Figure V). • Peel off the foil from a needle.	Figure V
• Push and screw the needle onto the metal front part of your pen as shown (See Figure W). Remove the outer needle cover and inner needle cap. • Follow the instructions above, starting with Step 8: Attach the Needle Guard.	Figure W
Step 13. To Replace the Cartridge • Press the red release button to reset your pen (See Figure X).	Figure X
• Turn the injection button in a counter clockwise direction (to the left) as far as it will go as shown (See Figure Y). This will draw back the plunger rod.	Figure Y
• Unscrew the metal front part and remove the empty cartridge (See Figure Z). • Throw away the empty cartridge as instructed by your healthcare provider. • To insert a new cartridge and prepare your pen for reuse, follow the instructions starting with Step 1.	Figure Z

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

•: Do not reuse needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Dispose of the entire GENOTROPIN PEN 12 as electronic waste per state and local regulations.

Figure AA

Caring for your Pen

Questions and Answers
Question	Answer
How long is the use period of my pen?	The pen has a use period of 2 years starting from the first use by the patient.
How can I tell how much GENOTROPIN is left in my pen?	The indicative scale along the side of the cartridge window is a guide. The number that aligns with the front edge of the rubber stopper shows you how many milligrams are left in the cartridge. If your cartridge is nearly empty you can also dial the injection button until it cannot go any further, the dose display will then show the maximum dose that can be delivered. When the cartridge is empty, the injection button will not turn any further.
If the display does not work, can my pen still be used?	Contact your healthcare provider as soon as possible to get a new pen.
What happens if I dial the injection button beyond the maximum dose ('4.0' mg)?	Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. This is normal and will not affect your injection. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display. Then dial back to your correct dose.
Why is it difficult to turn or push the injection button?	The injection button may become difficult to turn or to push. This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Contact your healthcare provider if the issue does not resolve.

Display Information

	Steady		The selected dose size. The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.
	Steady		A dose is not set. The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose.
	Flashing		The injection button is rotated too fast or too slow. Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		The injection button is rotated too fast or too slow. Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.
	Flashing		1 month before the end of the 2 year use period.
	(5 seconds)		This is normal. The dose can be set and read from the display. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Pen has reached the end of its use period of 2 years.
			The display will continue to show until the battery is completely empty. This does not indicate a problem with your pen. Your pen can still be used correctly, but the dose size will not be displayed. Contact your healthcare provider right away to get a new Pen.
	Flashing		Battery charge is low and will be empty in 1 month.
	(5 seconds)		Afterwards the dose can be set and your pen can be used correctly. Contact your healthcare provider as soon as possible to get a new Pen.
	Steady		Battery power low. The dose cannot be displayed. Contact your healthcare provider right away to get a new Pen.
	Steady		Blank screen To save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery.

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Caution: Federal law restricts this device to sale by or on the order of a physician.

Manufactured by:
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc.
New York, NY 10001
U.S. License No. 1216

LAB-0224-10.0

Revised August 2024

INSTRUCTIONS FOR USE
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing GENOTROPIN (somatropin) for injection

Important Note

GENOTROPIN MINIQUICK is available in 10 dose strengths. Check your GENOTROPIN MINIQUICK to be sure you have the dose your healthcare provider prescribed.

GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.

For each injection you will need:

•: 2 alcohol pads (not included)
•: 1 GENOTROPIN MINIQUICK device with the single‑dose 2-chamber cartridge of GENOTROPIN inside. The 2-chamber cartridge of GENOTROPIN contains the growth hormone powder in one chamber and the liquid in the other.
•: 1 injection needle. A needle for injection is provided with each device. If you need additional needles, ask your healthcare provider for a 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle.
•: 1 sharps disposal container (not included). See "Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles" in Step 12.

Parts of the GENOTROPIN MINIQUICK (See Figure A)

Storage instructions for your GENOTROPIN MINIQUICK

•: Keep your GENOTROPIN MINIQUICK in the original carton to protect it from light.
•: Before you mix the growth hormone powder with the liquid in the syringe, you can store the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). You can also store the GENOTROPIN MINIQUICK at room temperature between 68ºF to 77ºF (20ºC to 25ºC) for up to 3 months. Do not freeze.
•: Inject the GENOTROPIN right after you mix it. If that is not possible, you can keep the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours after mixing it. Do not freeze.

Using your GENOTROPIN MINIQUICK

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN MINIQUICK.

Step 2.
Open the plastic bag that contains your GENOTROPIN MINIQUICK by tearing the bag along the dotted lines on the plastic.

Step 3. Wipe the rubber stopper on the GENOTROPIN MINIQUICK with an alcohol pad. (See Figure B)	Figure B
Step 4. Peel the seal from the back of the injection needle. Leave both the inner needle cover and the outer needle cover on the needle. (See Figure C)	Figure C
Step 5. • Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn. • Make sure the needle is placed directly over the rubber stopper (not at an angle), before screwing the needle onto the rubber stopper of the GENOTROPIN MINIQUICK. (See Figure D)	Figure D
Step 6. • Hold the GENOTROPIN MINIQUICK with the needle pointing up. Turn the plunger rod clockwise (to the right) until it will not go any further. (See Figure E) This will automatically mix the growth hormone powder and the liquid. • Do not shake the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well. • Make sure the solution (combined growth hormone powder and liquid) is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, do not inject it. Call the Pfizer Bridge Program at 1-800-645-1280.	Figure E
Step 7. • Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be at least 1 inch from the site you used before (See Figure F). Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas that have scars or skin problems. • Clean the injection site with the alcohol swab. Allow the injection site to dry.	Figure F
Step 8. • Remove the outer needle cover and the inner needle cover from the needle. Save the outer needle cover. (See Figure G)	Figure G
Step 9. • Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. (See Figure H)	Figure H
Step 10. • Push the plunger rod in as far as it will go, to inject all of the medicine in the GENOTROPIN MINIQUICK into the fold of skin. (See Figure I) • Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.	Figure I
Step 11 • Replace the outer needle cover on the needle. (See Figure J)	Figure J

Step 12. Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles

Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the household trash.

If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:

•: Made of a heavy-duty plastic,
•: Can be closed with a tight fitting, puncture-resistant lid, without sharps being able to come out,
•: Upright and stable during use,
•: Leak-resistant, and
•: Properly labeled to warn of hazardous waste inside the container.

When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.

•: Do not reuse the GENOTROPIN MINIQUICK or needles.
•: Do not throw away (dispose of) your used sharps disposal container in your household trash unless your community guidelines permit this.
•: Do not recycle your used sharps disposal container.

Important: Always keep the sharps disposal container out of the reach of children.

Questions and Answers
Question	Answer
Is it a problem if I see air bubbles in the syringe?	No. There is no need to remove the air bubbles from the GENOTROPIN MINIQUICK. The small amount of air in the syringe does not affect your injection.
What should I do if I have problems turning the plunger rod (Step 6)?	The problem could be because the needle has been inserted at an angle onto the rubber stopper. Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.
What should I do if I have problems pushing the plunger when making the injection (Step 10)?	The problem could be because the needle has been inserted at an angle onto the rubber stopper. Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle. Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device.
What should I do if the needle is damaged or bent?	Throw away the needle and use a new needle with the GENOTROPIN MINIQUICK. See "Disposing of (throwing away) your GENOTROPIN MINIQUICK and needles".

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Pharmacia & Upjohn Company LLC
A subsidiary of Pfizer Inc.
New York, NY 10001

U.S. License No. 1216
Logo

LAB-0227-9.0
Revised: August 2024

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