Voxelotor (vox-EL-oh-tor)

Treats sickle cell disease.

Brand Name(s):

Oxbryta

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the regular tablet whole. Do not crush, break, or chew it.
• Tablet for suspension:
  • Do not swallow whole, cut, crush, or chew the tablets.
  • Mix the tablet in a room temperature clear liquid (including drinking water, apple juice, clear electrolyte drinks, clear flavored drinks, clear soda, or clear sports drinks) before swallowing.
  • Swirl the oral liquid until the tablets break apart in the drink. The tablet will not completely dissolve. You will still see small tablet clumps in the mixture. Wait for 1 to 5 minutes, then swirl the mixture again and drink until no tablet residue is left in the cup.
• Your doctor may want you to take hydroxyurea while taking this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with St John's wort.
• Some medicines can affect how voxelotor works. Tell your doctor if you are using efavirenz, fluconazole, itraconazole, ketoconazole, midazolam, or rifampin.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or if you have liver disease. Tell your doctor if you are receiving blood transfusions.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose.
• This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS).
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing
• Fever, chills, cough sore throat, body aches
• Swelling of the face, eyes, lips, or tongue
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, nausea, stomach pain
• Headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088