Voxelotor

Voxelotor

Voxelotor

What is Voxelotor?

Voxelotor is sometimes given with another medicine called hydroxyurea.

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

Side effects of voxelotors

If necessary, get emergency medical helpSigns 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

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

Before you take this medicine

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 whether voxelotor will harm an unborn child. Tell your doctor if you are pregnant or planning to become pregnant.

Do not breast-feed while using Voxelotor.and for at least 2 weeks after your last dose.

How should I take Voxelotor?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You can take voxelotor once daily 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 a clear liquid at room temperature, e.g., just before taking. B. Water, clear soda, apple juice, clear electrolyte drink, clear flavored drink or clear sports drink. Do not swallow, break, crush or chew the dispersible tablets whole.

Your dosage needs may change if you change to a different brand, strength, or form of this medication. Avoid medication errors by only taking the medications 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, protected from moisture and heat. Store the tablets in their original container along with the package or canister containing the moisture-absorbing preservative.

Voxelotor dosage information

Usual Adult Dose for Sickle Cell Anemia:

1500 mg orally once daily

Comment:
-This medication may be administered with or without hydroxyurea.

Uses: For the treatment of sickle cell anemia.

Usual Pediatric Dose for Sickle Cell Anemia:

4 to under 12 years:
-Weight: 10 to less than 20 kg: 600 mg orally once daily
-Weight: 20 to less than 40 kg: 900 mg orally once daily
-Weight 40 kg or more: 1500 mg orally once daily

12 years or older: 1500 mg orally once daily

Comment:
-This medication may be administered with or without hydroxyurea.

Application: For the treatment of sickle cell anemia in patients aged 4 years and over.

What happens if I miss a dose?

Skip the missed dose and take the next dose at the regular time. Do not use two doses at the same time.

What happens if I overdose?

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

What should I avoid while taking voxelotor?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect voxelotor?

Tell your doctor about all medications you are currently taking. Many medications can affect the voxelotor, particularly:

• phenobarbital or other barbiturate drugs;

• St. John's wort;

• an antibiotic – rifabutin, rifampin, rifapentine;

• Cancer drugs – apalutamide, enzalutamide, mitotane;

• HIV or AIDS medications – efavirenz, nevirapine;

• Seizure medications – carbamazepine, oxcarbazepine, phenytoin, primidone; or

• Steroid medications – dexamethasone, prednisone.

This list is not exhaustive and many other medications can affect voxelotor. This includes prescription and over-the-counter medications, vitamins and herbal products. Not all possible drug interactions are listed here.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.