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About Sickle Cell
About Oxbryta
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Taking Oxbryta

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- Full Prescribing Information (English)
Patient Information and Instructions for Use
- Patient Information and Instructions for Use (English)
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IMPORTANT SAFETY INFORMATION & USE

IMPORTANT SAFETY INFORMATION & USE

IMPORTANT SAFETY
INFORMATION & USE

IMPORTANT SAFETY INFORMATION

Do not take OXBRYTA if you or your child have had an allergic reaction to voxelotor or any of the ingredients in OXBRYTA. See the end of the patient leaflet for a list of the ingredients in OXBRYTA.

Before taking OXBRYTA, tell your healthcare provider about all of your medical conditions, including if you or your child:

have liver problems
are pregnant or plan to become pregnant. It is not known if OXBRYTA can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if OXBRYTA can pass into your breastmilk and if it can harm your baby. Do not breastfeed during treatment with OXBRYTA and for at least 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how OXBRYTA works. OXBRYTA may also affect how other medicines work and may affect the results of certain blood tests. Keep a list of all your medicines and show it to your healthcare provider.

What should I avoid while taking OXBRYTA?

Do not take St. John’s wort during treatment with OXBRYTA.

What are the possible side effects of OXBRYTA?

OXBRYTA can cause serious side effects, including:

Severe skin rash and serious allergic reactions. Treatment with OXBRYTA may cause severe skin reactions and serious allergic reactions. The organs in your body may also be affected, such as your liver, kidneys or lungs, and your blood cells.
Stop taking OXBRYTA, and tell your healthcare provider or get emergency medical help right away if you develop any of the following signs or symptoms during treatment:

rash
hives
high temperature (fever)
swollen glands (lymph nodes)
trouble swallowing

shortness of breath (difficult breathing)
swelling of your face, around your eyes, lips, or tongue
lack of energy and tiredness (fatigue)
muscle or joint aches

The most common side effects of OXBRYTA include:

headache
nausea or vomiting
fever

stomach-area (abdominal) pain
diarrhea
rash or hives

These are not all the possible side effects of OXBRYTA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

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

What is OXBRYTA?

OXBRYTA is a prescription medicine used for the treatment of sickle cell disease in adults and children 4 years of age and older. It is not known if OXBRYTA is safe and effective in children with sickle cell disease below 4 years of age.

OXBRYTA is approved under accelerated approval based on an increase in hemoglobin. Continued approval may depend on verification of clinical benefits in ongoing trials.

Oxbryta^® is a registered trademark of Global Blood Therapeutics, Inc., a wholly owned subsidiary of Pfizer Inc., and YourSource^TM is a trademark of Pfizer Inc.

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You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.

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