Oxbryta For Oral Susp Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Tabs 300mg—60, 90; 500mg—90; Tabs for Oral Susp—60, 90
Manufacturer
Generic Availability
Mechanism of Action
Oxbryta For Oral Susp Indications
Indications
Oxbryta For Oral Susp Dosage and Administration
Adult
Swallow tabs whole. If difficulty swallowing, tabs for oral susp may be used; disperse tabs for oral susp in room temp clear liquid (eg, water, clear soda, apple juice) before swallowing. ≥12yrs: 1500mg once daily. Severe hepatic impairment: 1000mg once daily. Avoid concomitant strong or moderate CYP3A4 inducers; if unavoidable, increase dose to 2000mg once daily (with moderate CYP3A4 inducers); 2500mg once daily (with strong CYP3A4 inducers).
Children
<4yrs: not established. Use tabs or tabs for oral susp based on the ability to swallow and body weight. Disperse tabs for oral susp in room temp clear liquid (eg, water, clear soda, apple juice) before swallowing. 4–<12yrs (10–<20kg): 600mg once daily; (20–<40kg): 900mg once daily; (≥40kg): 1500mg once daily. Severe hepatic impairment (10–<20kg): 300mg once daily; (20–<40kg): 600mg once daily; (≥40kg): 1000mg (two 500mg tabs) or 900mg (three 300mg tabs for oral susp or three 300mg tabs) once daily. Avoid concomitant strong or moderate CYP3A4 inducers; if unavoidable with moderate CYP3A4 inducers (10–<20kg): 900mg once daily; (20–<40kg): 1200mg once daily; (≥40kg): 2000mg (four 500mg tabs) or 2100mg (seven 300mg tabs for oral susp or seven 300mg tabs) once daily; if unavoidable with strong CYP3A4 inducers (10–<20kg): 900mg once daily; (20–<40kg): 1500mg once daily; (≥40kg): 2500mg (five 500mg tabs) or 2400mg (eight 300mg tabs for oral susp or eight 300mg tabs) once daily.
Oxbryta For Oral Susp Contraindications
Not Applicable
Oxbryta For Oral Susp Boxed Warnings
Not Applicable
Oxbryta For Oral Susp Warnings/Precautions
Warnings/Precautions
Discontinue if hypersensitivity reactions occur; do not reinitiate. Severe hepatic impairment: reduce dose. Pregnancy. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Oxbryta For Oral Susp Pharmacokinetics
Absorption
Median plasma and whole blood Tmax is 2 hours after oral administration. Mean peak concentrations in whole blood and RBCs are observed between 6 and 18 hours after oral administration. High-fat, high-calorie meal increased AUC and Cmax.
Distribution
Apparent volume of distribution: 333 L (in central compartment); 72.3 L (in plasma). Plasma protein bound: 99.8%.
Elimination
Fecal (62.6%), renal (35.5%). Half-life: 38.7 hours. Apparent oral clearance: ~6.1 L/h in plasma.
Oxbryta For Oral Susp Interactions
Interactions
Oxbryta For Oral Susp Adverse Reactions
Adverse Reactions
Headache, diarrhea, abdominal pain, nausea, rash, pyrexia, vomiting; hypersensitivity reactions (eg, DRESS).
Oxbryta For Oral Susp Clinical Trials
See Literature
Oxbryta For Oral Susp Note
Not Applicable
Oxbryta For Oral Susp Patient Counseling
See Literature