Oxbryta is a prescription medicine used to treat sickle cell disease (an inherited blood disease) in adults and children 4 years of age and older.

Oxbryta is sometimes given together with another medicine called hydroxyurea.

Oxbryta belongs to a class of medications called hemoglobin S (HbS) polymerization inhibitors. Voxelotor works by helping hemoglobin (a protein in red blood cells) to hold onto more oxygen and to stop red blood cells from becoming misshapen.

Use Oxbryta only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tell your healthcare provider about all the medicines you or your child take. Some medicines may interact with voxelotor. Oxbryta may also affect how other medicines work and may affect the results of some blood tests.

Before taking this medicine

You should not use Oxbryta if you are allergic to voxelotor.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver problems.

It is not known if voxelotor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Take Oxbryta exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Oxbryta once per day with or without food.

Tablets: swallow the tablet whole and do not crush, chew, or break it.

Tablets for oral suspension: mix the tablets for oral suspension in room temperature clear liquid, such as water, clear soda, apple juice, clear electrolyte drink, clear flavored drink, or clear sports drink, just before taking it. Do not swallow whole, break, crush, or chew the tablets for oral suspension.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the medicine your doctor prescribes.

Voxelotor can affect the results of certain blood tests. Tell any doctor who treats you that you are using Oxbryta.

You should not stop using Oxbryta without your doctor's advice.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Usual Adult Dose for Sickle Cell Anemia:

1500 mg orally once a day

Comment:
-This drug may be given with or without hydroxyurea.

Use: For the treatment of sickle cell disease.

Usual Pediatric Dose for Sickle Cell Anemia:

4 to less than 12 years:
-Weight: 10 to less than 20 kg: 600 mg orally once a day
-Weight: 20 to less than 40 kg: 900 mg orally once a day
-Weight 40 kg or greater: 1500 mg orally once a day

12 years or older: 1500 mg orally once a day

Comment:
-This drug may be given with or without hydroxyurea.

Use: For the treatment of sickle cell disease in patients 4 years or older.

You should not use Oxbryta if you are allergic to voxelotor.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver problems.

It is not known if voxelotor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Oxbryta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common Oxbryta side effects may include:

• headache;

• fever;

• hives, rash; or

• stomach pain, nausea, diarrhea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can interact with voxelotor, especially:

• phenobarbital or other barbiturate medicine;

• St. John's wort;

• an antibiotic - rifabutin, rifampin, rifapentine;

• cancer medicine - apalutamide, enzalutamide, mitotane;

• HIV or AIDS medicine - efavirenz, nevirapine;

• seizure medicine - carbamazepine, oxcarbazepine, phenytoin, primidone; or

• steroid medicine - dexamethasone, prednisone.

This list is not complete and many other drugs may interact with voxelotor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.