OXBRYTA Instructions For Use

(voxelotor)

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

Revised: 08/2023

INSTRUCTIONS FOR USE
OXBRYTA [ox brye ta]
(voxelotor)
tablets for oral suspension
300 mg

This Instructions for Use contains information on how to take OXBRYTA tablets for oral suspension.
Read this Instructions for Use before you or your child start taking OXBRYTA tablets for oral suspension for the first time and each time you or your child get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.
Talk to your healthcare provider or pharmacist if you have questions about how to take or give the prescribed dose of OXBRYTA tablets for oral suspension.

Important Information You Need to Know Before Taking OXBRYTA Tablets for Oral Suspension:

•
Take OXBRYTA tablets for oral suspension exactly as your healthcare provider tells you.
•
Your healthcare provider will tell you how many OXBRYTA tablets for oral suspension you will need for your or your child's dose.
•
OXBRYTA comes in two different dosage forms. Each time you receive your or your child's prescription, check the bottle to make sure that you received the prescribed dosage form of OXBRYTA tablets for oral suspension. OXBRYTA tablets for oral suspension are light yellow to yellow, round shaped, and marked with "300 D" on one side. Contact your pharmacist or healthcare provider if you did not receive the correct dosage form.
•
Do not swallow whole, cut, crush, or chew OXBRYTA tablets for oral suspension.
•
You must first mix OXBRYTA tablets for oral suspension in room temperature clear drink, such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks, before swallowing.
•
If you or your child miss a dose of OXBRYTA tablets for oral suspension or if the entire dose is not taken, skip that dose and return to the normal dosing schedule the next day.
•
For more information about OXBRYTA tablets for oral suspension, see the Patient Information leaflet.

Gather supplies

You will need the following items to prepare the dose of OXBRYTA tablets for oral suspension (not included with OXBRYTA tablets for oral suspension):

•
a teaspoon
•
a small cup
•
room temperature clear drink, such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks.

You will also need:

•
the prescribed number of OXBRYTA tablets for oral suspension needed for your dose.
Figure

Preparing a dose of OXBRYTA tablets for oral suspension

Step 1.

Wash and dry your hands well before preparing the dose.

Step 2.

Pour room temperature clear drink into the cup. The table below shows the amount of clear drink needed for your prescribed dose. You may add more clear drink if needed to mix the tablets.

Step 2

Number of OXBRYTA Tablets for Oral Suspension

Amount of Clear Drink

1

1 teaspoon (5 mL)

2

2 teaspoons (10 mL)

3

3 teaspoons (15 mL)

4

4 teaspoons (20 mL)

5

5 teaspoons (25 mL)

7

7 teaspoons (35 mL)

8

8 teaspoons (40 mL)

   
   

Step 3.

Add the prescribed number of OXBRYTA tablets for oral suspension into the cup.

Step 3

Step 4.

Swirl the cup until the tablet(s) break apart (disperse) in the drink. Be careful not to spill the mixture.

•
The tablet(s) will not completely dissolve. You will still see small tablet clumps in the mixture.
•
If you spill any medicine, clean up the spill. Throw away the rest of the prepared medicine and make a new dose.
Step 4

Step 5.

Wait for 1 to 5 minutes.

Step 5

Giving the dose

Step 6.

Swirl the cup again. Take or give all of the prepared medicine right away.

•
If giving to a child, make sure that your child is upright when drinking the medicine mixture.
Step 6

Step 7.

Add 1 or 2 teaspoons of room temperature clear drink to the cup to make sure the full dose is taken. Swirl the cup until the remaining medicine is mixed and take or give it right away.

•
Repeat this step until no more medicine is left in the cup.
•
After all the medicine is taken, you or your child may drink more water or any type of drink.
Step 7

Step 8.

Wash the teaspoon and cup with warm soap and water.

Storing OXBRYTA

•
Store OXBRYTA between 68°F to 86°F (20°C to 30°C).
•
The OXBRYTA bottle comes with a child-resistant closure.
•
The OXBRYTA tablets for oral suspension bottle contains a polyester coil. Do not eat the polyester coil.

Keep OXBRYTA and all medicines out of the reach of children.

Disposing of OXBRYTA
When all the tablets in the bottle have been taken, throw away the bottle. Safely dispose of (throw away) OXBRYTA that is out of date or no longer needed using your local household waste guidelines.

Logo

Distributed by

Global Blood Therapeutics, Inc

A subsidiary of Pfizer Inc.

South San Francisco, CA 94080

LAB-1568-1.0

For more information, go to www.pfizer.com or call 1-800-438-1985.

Find OXBRYTA medical information:

Find OXBRYTA 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.

OXBRYTA Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Instructions For Use

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

Revised: 08/2023

INSTRUCTIONS FOR USE
OXBRYTA [ox brye ta]
(voxelotor)
tablets for oral suspension
300 mg

This Instructions for Use contains information on how to take OXBRYTA tablets for oral suspension.
Read this Instructions for Use before you or your child start taking OXBRYTA tablets for oral suspension for the first time and each time you or your child get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.
Talk to your healthcare provider or pharmacist if you have questions about how to take or give the prescribed dose of OXBRYTA tablets for oral suspension.

Important Information You Need to Know Before Taking OXBRYTA Tablets for Oral Suspension:

•
Take OXBRYTA tablets for oral suspension exactly as your healthcare provider tells you.
•
Your healthcare provider will tell you how many OXBRYTA tablets for oral suspension you will need for your or your child's dose.
•
OXBRYTA comes in two different dosage forms. Each time you receive your or your child's prescription, check the bottle to make sure that you received the prescribed dosage form of OXBRYTA tablets for oral suspension. OXBRYTA tablets for oral suspension are light yellow to yellow, round shaped, and marked with "300 D" on one side. Contact your pharmacist or healthcare provider if you did not receive the correct dosage form.
•
Do not swallow whole, cut, crush, or chew OXBRYTA tablets for oral suspension.
•
You must first mix OXBRYTA tablets for oral suspension in room temperature clear drink, such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks, before swallowing.
•
If you or your child miss a dose of OXBRYTA tablets for oral suspension or if the entire dose is not taken, skip that dose and return to the normal dosing schedule the next day.
•
For more information about OXBRYTA tablets for oral suspension, see the Patient Information leaflet.

Gather supplies

You will need the following items to prepare the dose of OXBRYTA tablets for oral suspension (not included with OXBRYTA tablets for oral suspension):

•
a teaspoon
•
a small cup
•
room temperature clear drink, such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks.

You will also need:

•
the prescribed number of OXBRYTA tablets for oral suspension needed for your dose.
Figure

Preparing a dose of OXBRYTA tablets for oral suspension

Step 1.

Wash and dry your hands well before preparing the dose.

Step 2.

Pour room temperature clear drink into the cup. The table below shows the amount of clear drink needed for your prescribed dose. You may add more clear drink if needed to mix the tablets.

Step 2

Number of OXBRYTA Tablets for Oral Suspension

Amount of Clear Drink

1

1 teaspoon (5 mL)

2

2 teaspoons (10 mL)

3

3 teaspoons (15 mL)

4

4 teaspoons (20 mL)

5

5 teaspoons (25 mL)

7

7 teaspoons (35 mL)

8

8 teaspoons (40 mL)

   
   

Step 3.

Add the prescribed number of OXBRYTA tablets for oral suspension into the cup.

Step 3

Step 4.

Swirl the cup until the tablet(s) break apart (disperse) in the drink. Be careful not to spill the mixture.

•
The tablet(s) will not completely dissolve. You will still see small tablet clumps in the mixture.
•
If you spill any medicine, clean up the spill. Throw away the rest of the prepared medicine and make a new dose.
Step 4

Step 5.

Wait for 1 to 5 minutes.

Step 5

Giving the dose

Step 6.

Swirl the cup again. Take or give all of the prepared medicine right away.

•
If giving to a child, make sure that your child is upright when drinking the medicine mixture.
Step 6

Step 7.

Add 1 or 2 teaspoons of room temperature clear drink to the cup to make sure the full dose is taken. Swirl the cup until the remaining medicine is mixed and take or give it right away.

•
Repeat this step until no more medicine is left in the cup.
•
After all the medicine is taken, you or your child may drink more water or any type of drink.
Step 7

Step 8.

Wash the teaspoon and cup with warm soap and water.

Storing OXBRYTA

•
Store OXBRYTA between 68°F to 86°F (20°C to 30°C).
•
The OXBRYTA bottle comes with a child-resistant closure.
•
The OXBRYTA tablets for oral suspension bottle contains a polyester coil. Do not eat the polyester coil.

Keep OXBRYTA and all medicines out of the reach of children.

Disposing of OXBRYTA
When all the tablets in the bottle have been taken, throw away the bottle. Safely dispose of (throw away) OXBRYTA that is out of date or no longer needed using your local household waste guidelines.

Logo

Distributed by

Global Blood Therapeutics, Inc

A subsidiary of Pfizer Inc.

South San Francisco, CA 94080

LAB-1568-1.0

For more information, go to www.pfizer.com or call 1-800-438-1985.
Medication Guide

Health Professional Information

{{section_name_patient}}

{{section_body_html_patient}}

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Speak with a Pfizer Medical Information Professional regarding your medical inquiry. Available 9AM-5PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.