Source: FDA, National Drug Code (US) Revision Year: 2020
OXBRYTA is indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older.
This indication is approved under accelerated approval based on increase in hemoglobin (Hb) [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
The recommended dosage of OXBRYTA is 1,500 mg taken orally once daily with or without food. If a dose is missed, continue dosing on the day following the missed dose.
Patients should swallow OXBRYTA tablets whole. Do not cut, crush, or chew the tablets.
OXBRYTA may be given with or without hydroxyurea.
The recommended dosage of OXBRYTA in patients with severe hepatic impairment (Child Pugh C) is 1,000 mg taken once daily with or without food. No dosage adjustment of OXBRYTA is required for patients with mild or moderate hepatic impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Avoid concomitant use of strong or moderate CYP3A4 inducers, strong CYP3A4 inhibitors, or fluconazole with OXBRYTA [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. If concomitant use of strong or moderate CYP3A4 inducers, strong CYP3A4 inhibitors, or fluconazole is unavoidable, adjust the OXBRYTA dosage as recommended in Table 1.
Table 1. OXBRYTA Recommended Dosage for Concomitant Medications:
| Concomitant Medication | Recommended OXBRYTA Dosage |
|---|---|
| Strong CYP3A4 inhibitors or fluconazole | 1,000 mg once daily |
| Strong or moderate CYP3A4 inducers | 2,500 mg once daily |
Store at or below 30°C (86°F).
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