HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use OXBRYTA safely and effectively. See full prescribing information for OXBRYTA. OXBRYTA® (voxelotor) tablets, for oral use OXBRYTA® (voxelotor) tablets for oral suspension Initial U.S. Approval: 2019 INDICATIONS AND USAGEOXBRYTA is a hemoglobin S polymerization inhibitor indicated for the treatment of sickle cell disease in adults and pediatric patients 4 years of age and older. This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). (1) DOSAGE AND ADMINISTRATIONOXBRYTA can be taken with or without food. (2.7) Recommended dosage:
Recommended dosage for severe hepatic impairment (Child Pugh C): CONTRAINDICATIONSPrior drug hypersensitivity to voxelotor or excipients. (4) WARNINGS AND PRECAUTIONSADVERSE REACTIONSMost common adverse reactions (incidence ≥10% with a difference of >3% compared to placebo) are headache, diarrhea, abdominal pain, nausea, rash, and pyrexia. (6.1) Most common adverse reactions (incidence >10%) reported in pediatric patients 4 to <12 years are pyrexia, vomiting, rash, abdominal pain, diarrhea, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Global Blood Therapeutics, Inc. at 1-833-GBT-4YOU (1-833-428-4968) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONSLactation: Advise not to breastfeed. (8.2) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 10/2022 |
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OXBRYTA Highlights (voxelotor)
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