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Voxelotor

Also known as: Oxbryta

Hemoglobin S Polymerization InhibitorHemoglobin S Polymerization InhibitorsCytochrome P450 3A4 Inhibitors

Route: Oral

2 interactions on record

Voxelotor has 2 known drug interactions based on U.S. FDA drug labeling data. 1 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Exagamglogene Autotemcel, Midazolam. Patients taking Voxelotor should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 1
Moderate: 1

Major (1)

Voxelotor + Exagamglogene Autotemcel— Discontinue at least 8 weeks prior to start of mobilization and conditioning due to unknown interaction potential with m…

Moderate (1)

Voxelotor + Midazolam— Voxelotor increased systemic exposure of midazolam. Avoid coadministration or consider dose reduction of midazolam.

Voxelotor + Exagamglogene Autotemcel⚠️Major

Discontinue at least 8 weeks prior to start of mobilization and conditioning due to unknown interaction potential with mobilization and myeloablative conditioning agents.

Voxelotor + Midazolam🟡Moderate

Voxelotor increased systemic exposure of midazolam. Avoid coadministration or consider dose reduction of midazolam.

Contraindications

4 CONTRAINDICATIONS OXBRYTA is contraindicated in patients with a history of serious drug hypersensitivity reaction to voxelotor or excipients. Clinical manifestations may include generalized rash, urticaria, mild shortness of breath, mild facial swelling, and eosinophilia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ]. Prior drug hypersensitivity to voxelotor or excipients. ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary There are no available data on OXBRYTA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of voxelotor to pregnant rats and rabbits during organogenesis at exposures up to 2.8-times (rats) and 0.3-times (rabbits) the exposure at the maximum recommended human dose resulted in no adverse developmental effects (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is approximately 14% and up to 43%, respectively. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. There are adverse effects on maternal and fetal outcomes associated with SCD in pregnancy (see Clinical Considerations ). OXBRYTA should only be used during pregnancy if the benefit of the drug outweighs the potential risk. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women with SCD have an increased risk of adverse pregnancy outcomes for the mother and the fetus. Pregnant women are at greater risk for vasoocclusive crises, pre-eclampsia, eclampsia, and maternal mortality. For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality. Data Animal Data In embryo-fetal development studies, voxelotor was administered orally to pregnant rats at 15, 50, and 250 mg/kg/day (gestation days 7 through 17) and rabbits at 25, 75, and 150 mg/kg/day (gestation days 7 through 19) through organogenesis. Maternal toxicity was observed at the highest dose levels in these studies equivalent to 2.8-times (rats) and 0.3-times (rabbits) the exposures in patients receiving OXBRYTA at the recommended daily dose. There was no evidence of adverse developmental outcomes in rats or rabbits. In a pre- and postnatal development study, voxelotor was administered orally to pregnan

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.