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Skyclarys Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Caps—90
Manufacturer
Generic Availability
NO
Mechanism of Action
The precise mechanism by which omaveloxolone exerts its therapeutic effect in patients with Friedreich’s ataxia is unknown. Omaveloxolone has been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.
Skyclarys Indications
Indications
Friedreich's ataxia in patients ≥16yrs.
Skyclarys Dosage and Administration
Adult
Swallow whole. Take on empty stomach. ≥16yrs: 150mg (3 caps) once daily. Concomitant strong CYP3A4 inhibitor (if unavoidable): reduce to 50mg once daily; and monitor closely; discontinue if adverse reactions occur. Concomitant moderate CYP3A4 inhibitor (if unavoidable): reduce to 100mg once daily; monitor closely; if adverse reactions occur, further reduce to 50mg once daily. Moderate hepatic impairment: 100mg once daily; monitor closely; consider reducing to 50mg once daily if adverse reactions occur.
Children
<16yrs: not established.
Skyclarys Contraindications
Not Applicable
Skyclarys Boxed Warnings
Not Applicable
Skyclarys Warnings/Precautions
Warnings/Precautions
Elevation of aminotransferases. Monitor ALT, AST, total bilirubin prior to initiation, monthly for the first 3 months, and periodically thereafter. Discontinue immediately if transaminases increase >5×ULN or >3×ULN with evidence of liver dysfunction; repeat LFTs as soon as possible. May restart with increased monitoring if transaminases stabilize or resolve. Elevation of BNP; check prior to initiation. Monitor for fluid overload, peripheral edema, palpitations, shortness of breath; evaluate BNP, cardiac function, and manage if symptoms develop, worsen, or require hospitalization. Assess lipid levels prior to initiation; monitor periodically during therapy and manage appropriately. Severe hepatic impairment: not recommended. Advise females using hormonal contraceptives to use alternative method or additional non-hormonal contraceptive (eg, condoms) during and for 28 days after discontinuation. Pregnancy. Nursing mothers.
Skyclarys Pharmacokinetics
Absorption
Time to achieve peak plasma concentration was 7–14 (range: 1–24) hours.
Distribution
Serum protein binding: 97%.
Elimination
Fecal (~92%), renal (0.1%). Half-life: 57 hours (range: 32–90 hours).
Skyclarys Interactions
Interactions
Avoid concomitant moderate or strong CYP3A4 inhibitors; if unavoidable, consider dose reduction (see Adults). Avoid concomitant moderate or strong CYP3A4 inducers. May antagonize CYP3A4 and CYP2C8 substrates; monitor for reduced efficacy. May reduce efficacy of hormonal contraceptives; avoid use with combined hormonal contraceptives (eg, pill, patch, ring), implants, progestin only pills.
Skyclarys Adverse Reactions
Adverse Reactions
Elevated AST/ALT, headache, nausea, abdominal pain, fatigue, diarrhea, musculoskeletal pain, other lab abnormalities.
Skyclarys Clinical Trials
Skyclarys Note
Not Applicable
Skyclarys Patient Counseling
See Literature
