CAVERJECT® IMPULSE Instructions For Use

(alprostadil)

INSTRUCTIONS FOR USE
CAVERJECT [KAV-er-jeckt]®
(alprostadil)
for injection, for intracavernosal use

Before you use CAVERJECT, your doctor must train you in how to prepare and give the injection properly.

Before using CAVERJECT, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. Your dose has been selected for your individual needs. Do not change your dose without consulting your doctor. If you are not sure of the volume or dose to be used, talk to your doctor or pharmacist.

Follow these instructions exactly to properly prepare the syringe for use, and to correctly inject a sterile (germ-free) dose of CAVERJECT.

Supplies Needed

The CAVERJECT IMPULSE carton contains two (2) sealed plastic trays, with one dose of Caverject in each tray.

Each tray contains: (a) a syringe, (b) a separate needle assembly and (c) two alcohol swabs. The syringe and the needle assembly are shown in Figure A (below). Please note that the needle assembly is packaged as a single piece and is sealed with a paper cover on the bottom.

DO NOT try to assemble the syringe until you have read ALL of the instructions.

First-read through ALL of the instructions (Step 1 through Step 12) before trying to assemble the syringe. Then go back to Step 1 and begin to prepare the syringe for use.

Figure A

CAVERJECT IMPULSE is available in two versions: the 10 mcg strength (white plunger) and the 20 mcg strength (blue plunger). Each syringe is designed to be used only one time, but you can select the dose that will be delivered:

•
The 10 mcg strength syringe (white plunger) can deliver 10 mcg (the full dose), or one of three partial doses: 7.5 mcg, or 5 mcg, or 2.5 mcg.
•
The 20 mcg strength syringe (blue plunger) can deliver 20 mcg (the full dose), or one of three partial doses: 15 mcg, or 10 mcg, or 5 mcg.

If you deliver a partial dose there will be left-over solution in the syringe – this is normal.

MAKE SURE YOU HAVE THE CORRECT STRENGTH OF CAVERJECT IMPULSE to deliver your assigned dose

INSTRUCTIONS for PREPARING the SYRINGE (Step 1 through Step 12)

Wash your hands thoroughly and dry them with a clean towel.

STEP 1.

Open the sealed plastic tray. Remove the syringe, the needle assembly, and the alcohol swabs from the tray. All items should be present.

Look at the needle assembly. The needle assembly is a sealed unit that contains the outer protective cap, the inner protective cap, and the superfine needle, as shown in Figure A. It is sealed with a small round paper cover (not shown in Figure A).

Do not open the needle assembly at this point – leave it sealed inside the outer protective cap.

Next, examine the syringe. Find the location of the dose window. Right now you will not see anything in this window, but at a later Step, a number will appear in this window (the dose to be delivered).

Finally, look at the Plunger, but do not move it at this time. During the assembly process, some Steps may ask you to ROTATE the plunger and other steps may ask you to PUSH the plunger.

It is important to only rotate the plunger – or only push – as directed in each Step, but DO NOT do both at the same time.

                exclaim image




Never PUSH on the plunger – even slightly – while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

Figure B


STEP 2.


Open the packet containing the alcohol swab, and then pick up the syringe. Use the alcohol swab to wipe the rubber membrane at the tip of the syringe (Figure B). Discard the alcohol swab.

Figure C


STEP 3.


Pick up the Needle Assembly. Grab the paper tab and peel off the paper cover (lid) from the bottom of the needle assembly (Figure C).

Figure D


STEP 4.


Hold the needle assembly by the cap. Pick up the syringe with your other hand.

Press the needle assembly onto the tip of the syringe and turn it clockwise (like tightening a screw) until the needle assembly is firmly locked into place.

Remove (twist off - clockwise) the outer protective cap from the needle (Figure D), but DO NOT REMOVE the inner protective cap at this time. The inner protective cap is the thin plastic tube that directly covers the needle. It will be removed later.

If you are not sure which piece is the inner protective cap, see Figure A (Step 1) to identify the inner protective cap.


Figure E






STEP 5.



The next few steps will mix the powder and the fluid to make the Caverject Impulse solution.

Hold the syringe system with the needle pointing upward.

The plunger rod should still be in the fully extended position, with all of the threads visible, as shown in Figure E.

Figure F



STEP 6.



Slowly ROTATE the plunger rod clockwise (like tightening a screw,) until it goes all the way in and stops (Figure F).

This automatically combines the drug powder and the fluid.

exclaim image




DO NOT turn the plunger rod counter-clockwise (do not try to "unscrew" the plunger rod).

exclaim image



DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.



STEP 7.



Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Do not use it if it is cloudy or contains particles.

Figure G


STEP 8.



STEP 9.


Hold the syringe with the needle upward and carefully remove the inner protective cap from the needle (Figure G). Do not touch the exposed needle because it is sterile.

Next, you need to remove any large bubbles from the solution.

Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. Very small bubbles may remain.

Figure H


STEP 10.


With the syringe pointed upward (Figure H), use your thumb to push in the plunger rod until it stops.

This will push the air out. Some liquid will appear at the needle point.

After pressing the plunger you may still see some small bubbles on the wall of the glass cartridge. This is normal.



exclaim image





If you can't press the plunger rod in, check that the plunger rod is rotated all the way: turn it clockwise until it stops, and then repeat Step 10.



exclaim image





After the plunger is pushed in – Do Not rotate the plunger. That will be done in the next step.

Figure I


STEP 11.


PLEASE READ the following before going on.

In Step 11, you will need to set the dose by ROTATING the plunger until the correct dose appears in the small oval Dose Window on the syringe. The plunger must be rotated "clock-wise" – like tightening a screw.

Figure J

  exclaim image



DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

If the plunger does stick, you can try to free it by gently turning it backward ("unscrewing it") and trying again.



TO SET THE DOSE:

Locate the Dose Window on the syringe. This small oval window (above the left thumb in Figure I) is where the dose number will appear when the plunger is rotated.

Then – holding the syringe as shown in Figure I, slowly turn the plunger rod clockwise (like tightening a screw – see arrow in Figure I) until the correct dose number appears in the center of the window (Figure J).

If you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward

STEP 12.

The syringe is now ready for use.

Set the syringe down on a flat level surface.

The needle is sterile. Make sure the needle does not touch the surface or anything else.

How to give the injection

•
Make yourself comfortable. Take some time to relax yourself and your partner. If your doctor has recommended you use an alcohol cleansing swab, open one now.
•
Make sure that the needle is not bent. If it is, do not use it. Do not attempt to straighten the needle out. Properly discard it.
Figure K
1.
The injection will go into the part of the penis shown as the shaded area in Figure K. Do not inject into the white areas because there may be blood vessels in the white areas. Also see Figure L.
Figure L
2.
The correct injection angle is shown in Figure L.
3.
If your doctor has recommended that you use an alcohol swab, wipe over the area for injection and let it dry. Reconfirm that the correct dose is visible in the dose window. If the correct dose is not in the dose window, repeat Step 11.
Figure M
4.
Take hold of the penis from the front, with the first two fingers underneath close to the testicles and the thumb on top (Figure M).


5.
Gently squeeze the penis between your thumb and finger so that the injection site bulges out. If there is a foreskin on the penis, make sure it is stretched.


6.
Keeping a firm grip on the penis and taking the syringe in your free hand, push the needle straight through the skin all the way into the bulgy part (corpora cavernosa). Avoid veins or other obvious blood vessels (Figures K and L).


7.
Push the plunger firmly and steadily until it no longer moves. Plunger movement may be very small or undetectable if administering a partial dose.


8.
If the plunger does not move easily adjust the needle depth slightly and try again. Do not force the solution from the syringe.


9.
After completing the injection, carefully pull the needle out. A drop of liquid may remain on the tip of the needle. Press gently on the injection site with the alcohol swab. Massage the penis to help the Caverject Impulse solution spread through it.

Some liquid will remain in the syringe if you delivered a PARTIAL dose. This is expected. Do not try to inject left-over liquid from a partial dose. Syringes used to inject a partial dose must be discarded since each syringe can only be used one time. Discard syringes with left-over liquid.

 
o
A partial dose is 5 mcg, 10 mcg or 15 mcg for the BLUE plunger syringe.
o
A partial dose is 2.5 mcg, 5 mcg, or 7.5 mcg for the WHITE plunger syringe.

Do not keep any solution in the cartridge to use for a second injection. When you have finished with the syringe, discard it carefully as recommended by your doctor, so no one will use it or stick themselves with it.

After your injection:

Dispose of your used CAVERJECT IMPULSE syringes and needle.

•
Put your used CAVERJECT IMPULSE syringe and needle in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
•
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
o
made of a heavy-duty plastic
o
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
o
upright and stable during use
o
leak-resistant
o
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. Do not reuse or share your needles or syringes with other people. For more information about the 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 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.

How should I store CAVERJECT IMPULSE?

1.
Store unmixed CAVERJECT IMPULSE at room temperature between 68°F to 77°F (20°C to 25°C).
2.
Store mixed CAVERJECT IMPULSE between 36°F to 77°F (2°C to 25°C). Do not freeze.
3.
CAVERJECT IMPULSE should be used within 24 hours after it is mixed.

Keep CAVERJECT IMPULSE and all medicines out of the reach of children.

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

logo.jpg

LAB-1504-2.0

Revised January 2023

Find CAVERJECT® IMPULSE medical information:

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Prescribing Information
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Health Professional Information

Instructions For Use

INSTRUCTIONS FOR USE
CAVERJECT [KAV-er-jeckt]®
(alprostadil)
for injection, for intracavernosal use

Before you use CAVERJECT, your doctor must train you in how to prepare and give the injection properly.

Before using CAVERJECT, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. Your dose has been selected for your individual needs. Do not change your dose without consulting your doctor. If you are not sure of the volume or dose to be used, talk to your doctor or pharmacist.

Follow these instructions exactly to properly prepare the syringe for use, and to correctly inject a sterile (germ-free) dose of CAVERJECT.

Supplies Needed

The CAVERJECT IMPULSE carton contains two (2) sealed plastic trays, with one dose of Caverject in each tray.

Each tray contains: (a) a syringe, (b) a separate needle assembly and (c) two alcohol swabs. The syringe and the needle assembly are shown in Figure A (below). Please note that the needle assembly is packaged as a single piece and is sealed with a paper cover on the bottom.

DO NOT try to assemble the syringe until you have read ALL of the instructions.

First-read through ALL of the instructions (Step 1 through Step 12) before trying to assemble the syringe. Then go back to Step 1 and begin to prepare the syringe for use.

Figure A

CAVERJECT IMPULSE is available in two versions: the 10 mcg strength (white plunger) and the 20 mcg strength (blue plunger). Each syringe is designed to be used only one time, but you can select the dose that will be delivered:

•
The 10 mcg strength syringe (white plunger) can deliver 10 mcg (the full dose), or one of three partial doses: 7.5 mcg, or 5 mcg, or 2.5 mcg.
•
The 20 mcg strength syringe (blue plunger) can deliver 20 mcg (the full dose), or one of three partial doses: 15 mcg, or 10 mcg, or 5 mcg.

If you deliver a partial dose there will be left-over solution in the syringe – this is normal.

MAKE SURE YOU HAVE THE CORRECT STRENGTH OF CAVERJECT IMPULSE to deliver your assigned dose

INSTRUCTIONS for PREPARING the SYRINGE (Step 1 through Step 12)

Wash your hands thoroughly and dry them with a clean towel.

STEP 1.

Open the sealed plastic tray. Remove the syringe, the needle assembly, and the alcohol swabs from the tray. All items should be present.

Look at the needle assembly. The needle assembly is a sealed unit that contains the outer protective cap, the inner protective cap, and the superfine needle, as shown in Figure A. It is sealed with a small round paper cover (not shown in Figure A).

Do not open the needle assembly at this point – leave it sealed inside the outer protective cap.

Next, examine the syringe. Find the location of the dose window. Right now you will not see anything in this window, but at a later Step, a number will appear in this window (the dose to be delivered).

Finally, look at the Plunger, but do not move it at this time. During the assembly process, some Steps may ask you to ROTATE the plunger and other steps may ask you to PUSH the plunger.

It is important to only rotate the plunger – or only push – as directed in each Step, but DO NOT do both at the same time.

                exclaim image




Never PUSH on the plunger – even slightly – while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

Figure B


STEP 2.


Open the packet containing the alcohol swab, and then pick up the syringe. Use the alcohol swab to wipe the rubber membrane at the tip of the syringe (Figure B). Discard the alcohol swab.

Figure C


STEP 3.


Pick up the Needle Assembly. Grab the paper tab and peel off the paper cover (lid) from the bottom of the needle assembly (Figure C).

Figure D


STEP 4.


Hold the needle assembly by the cap. Pick up the syringe with your other hand.

Press the needle assembly onto the tip of the syringe and turn it clockwise (like tightening a screw) until the needle assembly is firmly locked into place.

Remove (twist off - clockwise) the outer protective cap from the needle (Figure D), but DO NOT REMOVE the inner protective cap at this time. The inner protective cap is the thin plastic tube that directly covers the needle. It will be removed later.

If you are not sure which piece is the inner protective cap, see Figure A (Step 1) to identify the inner protective cap.


Figure E






STEP 5.



The next few steps will mix the powder and the fluid to make the Caverject Impulse solution.

Hold the syringe system with the needle pointing upward.

The plunger rod should still be in the fully extended position, with all of the threads visible, as shown in Figure E.

Figure F



STEP 6.



Slowly ROTATE the plunger rod clockwise (like tightening a screw,) until it goes all the way in and stops (Figure F).

This automatically combines the drug powder and the fluid.

exclaim image




DO NOT turn the plunger rod counter-clockwise (do not try to "unscrew" the plunger rod).

exclaim image



DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.



STEP 7.



Turn the syringe upside down several times to make sure the solution is evenly mixed. The solution should be clear. Do not use it if it is cloudy or contains particles.

Figure G


STEP 8.



STEP 9.


Hold the syringe with the needle upward and carefully remove the inner protective cap from the needle (Figure G). Do not touch the exposed needle because it is sterile.

Next, you need to remove any large bubbles from the solution.

Lightly tap the glass cartridge a few times with your finger until any large bubbles disappear up into the tip. Very small bubbles may remain.

Figure H


STEP 10.


With the syringe pointed upward (Figure H), use your thumb to push in the plunger rod until it stops.

This will push the air out. Some liquid will appear at the needle point.

After pressing the plunger you may still see some small bubbles on the wall of the glass cartridge. This is normal.



exclaim image





If you can't press the plunger rod in, check that the plunger rod is rotated all the way: turn it clockwise until it stops, and then repeat Step 10.



exclaim image





After the plunger is pushed in – Do Not rotate the plunger. That will be done in the next step.

Figure I


STEP 11.


PLEASE READ the following before going on.

In Step 11, you will need to set the dose by ROTATING the plunger until the correct dose appears in the small oval Dose Window on the syringe. The plunger must be rotated "clock-wise" – like tightening a screw.

Figure J

  exclaim image



DO NOT PUSH on the plunger while trying to rotate it. This can cause the plastic threads on the plunger rod to stick.

If the plunger does stick, you can try to free it by gently turning it backward ("unscrewing it") and trying again.



TO SET THE DOSE:

Locate the Dose Window on the syringe. This small oval window (above the left thumb in Figure I) is where the dose number will appear when the plunger is rotated.

Then – holding the syringe as shown in Figure I, slowly turn the plunger rod clockwise (like tightening a screw – see arrow in Figure I) until the correct dose number appears in the center of the window (Figure J).

If you pass the correct number, keep turning the plunger in the same direction until the correct number comes around again – do not try to turn it backward

STEP 12.

The syringe is now ready for use.

Set the syringe down on a flat level surface.

The needle is sterile. Make sure the needle does not touch the surface or anything else.

How to give the injection

•
Make yourself comfortable. Take some time to relax yourself and your partner. If your doctor has recommended you use an alcohol cleansing swab, open one now.
•
Make sure that the needle is not bent. If it is, do not use it. Do not attempt to straighten the needle out. Properly discard it.
Figure K
1.
The injection will go into the part of the penis shown as the shaded area in Figure K. Do not inject into the white areas because there may be blood vessels in the white areas. Also see Figure L.
Figure L
2.
The correct injection angle is shown in Figure L.
3.
If your doctor has recommended that you use an alcohol swab, wipe over the area for injection and let it dry. Reconfirm that the correct dose is visible in the dose window. If the correct dose is not in the dose window, repeat Step 11.
Figure M
4.
Take hold of the penis from the front, with the first two fingers underneath close to the testicles and the thumb on top (Figure M).


5.
Gently squeeze the penis between your thumb and finger so that the injection site bulges out. If there is a foreskin on the penis, make sure it is stretched.


6.
Keeping a firm grip on the penis and taking the syringe in your free hand, push the needle straight through the skin all the way into the bulgy part (corpora cavernosa). Avoid veins or other obvious blood vessels (Figures K and L).


7.
Push the plunger firmly and steadily until it no longer moves. Plunger movement may be very small or undetectable if administering a partial dose.


8.
If the plunger does not move easily adjust the needle depth slightly and try again. Do not force the solution from the syringe.


9.
After completing the injection, carefully pull the needle out. A drop of liquid may remain on the tip of the needle. Press gently on the injection site with the alcohol swab. Massage the penis to help the Caverject Impulse solution spread through it.

Some liquid will remain in the syringe if you delivered a PARTIAL dose. This is expected. Do not try to inject left-over liquid from a partial dose. Syringes used to inject a partial dose must be discarded since each syringe can only be used one time. Discard syringes with left-over liquid.

 
o
A partial dose is 5 mcg, 10 mcg or 15 mcg for the BLUE plunger syringe.
o
A partial dose is 2.5 mcg, 5 mcg, or 7.5 mcg for the WHITE plunger syringe.

Do not keep any solution in the cartridge to use for a second injection. When you have finished with the syringe, discard it carefully as recommended by your doctor, so no one will use it or stick themselves with it.

After your injection:

Dispose of your used CAVERJECT IMPULSE syringes and needle.

•
Put your used CAVERJECT IMPULSE syringe and needle in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
•
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
o
made of a heavy-duty plastic
o
can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
o
upright and stable during use
o
leak-resistant
o
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. Do not reuse or share your needles or syringes with other people. For more information about the 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 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.

How should I store CAVERJECT IMPULSE?

1.
Store unmixed CAVERJECT IMPULSE at room temperature between 68°F to 77°F (20°C to 25°C).
2.
Store mixed CAVERJECT IMPULSE between 36°F to 77°F (2°C to 25°C). Do not freeze.
3.
CAVERJECT IMPULSE should be used within 24 hours after it is mixed.

Keep CAVERJECT IMPULSE and all medicines out of the reach of children.

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

logo.jpg

LAB-1504-2.0

Revised January 2023
Medication Guide

Health Professional Information

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