Voxelotor is used to treat sickle cell disease in adults and children at least 4 years old.

Voxelotor is sometimes given together with another medicine called hydroxyurea.

Voxelotor may also be used for purposes not listed in this medication guide.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take voxelotor 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 voxelotor.

You should not stop using voxelotor 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 voxelotor if you are allergic to it.

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 voxelotor, 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

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: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects of voxelotor 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 affect 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 affect voxelotor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking voxelotor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.