Oxbryta

Oxbryta is a prescription medication used to treat adults and children over 12 with sickle cell disease.

This medication belongs to a group of drugs called hemoglobin S (HbS) polymerization inhibitors. It works by directly working on hemoglobin S to interfere with the process that causes red blood cells to sickle.

Oxbryta comes in tablet form. It is taken once daily by mouth, with or without food. Do not cut, crush or chew the tablets.

Common side effects include headache, nausea, diarrhea, and rash.

Oxbryta is a prescription medicine used for the treatment of sickle cell disease in adults and children 12 years of age and older.

It is not known if Oxbryta is safe and effective in children below 12 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oxbryta may cause serious side effects. See "Oxbryta Precautions" section.

The most common side effects of Oxbryta include:

• headache
• diarrhea
• stomach (abdominal) pain
• nausea
• tiredness
• rash
• fever

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 Global Blood Therapeutics at 1-833-428-4968 (1-833-GBT-4YOU).

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take:

CYP3A4 Inhibitors: amiodarone, erythromycin, fluconazole, miconazole, diltiazem, verapamil, delavirdine, amprenavir, fosamprenavir, conivaptan, clarithromycin, itraconazole, ketoconazole, ritonavir, goldenseal and grapefruit, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

Inducers of CYP3A4: phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids.

Ask your healthcare provider if you are not sure if you are taking any of these medications.

Your healthcare provider or pharmacist can tell you if it is safe to take Oxbryta with your other medicines. Do not start or stop any medicine without talking to your healthcare provider first.

Oxbryta can cause serious side effects, including:

Serious allergic reactions. Tell your healthcare provider or get emergency medical help right away if you get:

• rash
• hives
• shortness of breath
• swelling of the face

Do not take Oxbryta if you have had an allergic reaction to voxelotor or any of the ingredients in Oxbryta. 

If you are receiving exchange transfusions, talk to your healthcare provider about possible difficulties with the interpretation of certain blood tests when taking Oxbryta.

Grapefruit and grapefruit juice may interact with this medication and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

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

• 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 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.

Tell your healthcare provider if you are pregnant or plan to become pregnant. You and your healthcare provider should decide if you should take Oxbryta while you are pregnant.

There are no well-done studies that have been done in humans with Oxbryta. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.

Tell your health care provider if you 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.

• Take Oxbryta exactly as your healthcare provider tells you.
• Do not change your dose or stop taking Oxbryta unless your healthcare provider tells you to.
• Take Oxbryta 1 time each day. Swallow each Oxbryta tablet whole. Do not cut, crush or chew the tablets.
  • Your healthcare provider may change your dose if needed.
• Your healthcare provider may also prescribe hydroxyurea during treatment with Oxbryta.
• Take Oxbryta with or without food.
• If you forget to take a dose of Oxbryta, skip that dose and return to your normal dosing schedule the next day.

Take Oxbryta exactly as it is prescribed by your doctor. 

The recommended dosage of Oxbryta is 1,500 mg taken orally once daily.

If you take too much Oxbryta, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• Store Oxbryta at or below 86°F (30°C).
• Oxbryta comes in a child-resistant package.
• The bottle contains a desiccant to help keep your medicine dry (protect it from moisture) and polyester coil. Do not eat.

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