Oxbryta For Oral Susp Generic Name & Formulations
Legal Class
Rx
General Description
Voxelotor 300mg; tabs for oral susp; grape flavor.
Pharmacological Class
Hemoglobin S polymerization inhibitor.
See Also
How Supplied
Tabs—90; Tabs for Oral Susp—60, 90
Manufacturer
Generic Availability
NO
Oxbryta For Oral Susp Indications
Indications
Sickle cell disease.
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 or clear soda) 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 or clear soda) 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) 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) 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) 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
Severe hepatic impairment: reduce dose. Pregnancy. Nursing mothers: not recommended (during and for ≥2 weeks after the last dose).
Oxbryta For Oral Susp Pharmacokinetics
See Literature
Oxbryta For Oral Susp Interactions
Interactions
May be antagonized by strong or moderate CYP3A4 inducers; if unavoidable, increase voxelotor dose. May be potentiated by strong CYP3A4 inhibitors. Avoid concomitant sensitive CYP3A4 substrates with a narrow therapeutic index; if unavoidable, consider dose reduction of the substrate. May interfere with measurement of Hb subtypes by high-performance liquid chromatography.
Oxbryta For Oral Susp Adverse Reactions
Adverse Reactions
Headache, diarrhea, abdominal pain, nausea, rash, pyrexia, vomiting; hypersensitivity reactions (discontinue if occur).
Oxbryta For Oral Susp Clinical Trials
See Literature
Oxbryta For Oral Susp Note
Not Applicable
Oxbryta For Oral Susp Patient Counseling
See Literature