voxelotor 500 mg tablet

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Medication name

Generic name:
Voxelotor - oral

Pronunciation
(vox-EL-oh-tor)

Brand name(s)
Oxbryta

Uses

This medication is used to treat sickle cell disease. People with sickle cell disease have a certain abnormal protein (hemoglobin S) in their red blood cells that makes the cells stiff and irregularly shaped (sickle- or crescent moon-shaped). Voxelotor works by decreasing hemoglobin S. This effect may decrease symptoms such as tiredness, shortness of breath, and attacks of pain (sickle cell crisis).

This drug has been withdrawn from the US market due to problems with safety.

How to use

Read the Patient Information Leaflet if available from your pharmacist before you start taking voxelotor and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication comes in 2 different tablet forms which are not taken the same way. Check that you receive the correct form each time you receive your medication to avoid taking the wrong form of this medication. Swallow the tablets whole. Do not cut, crush, or chew the tablets.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your symptoms do not get better or if they get worse.

Side effects

Headache, diarrhea, nausea, stomach/abdominal pain, or fever may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • fever
  • swollen lymph nodes
  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking voxelotor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • liver problems

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for at least 2 weeks after the last dose. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

  • elacestrant

Other medications can affect the removal of voxelotor from your body, which may affect how voxelotor works. Examples include azole antifungals (such as fluconazole, ketoconazole), efavirenz, macrolide antibiotics (such as erythromycin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood counts) should be done while you are taking this medication. Keep all medical and lab appointments.

Missed dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.