Omaveloxolone

Omaveloxolone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alen Antony Pathil, M.D.[2]

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Overview

Omaveloxolone is a Nuclear factor -like 2 (Nrf2) pathway activator that is FDA approved for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.. Common adverse reactions include transamnitis, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

omaveloxolone (SKYCLARYS) is used for the treatment of friedreich ataxia for adults and adolescents of age above 16 years.

The recommended dosage is 150mg (3 tablets of 50mg) taken orally once daily.

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Omaveloxolone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

none

Warnings

Elevation of AST/ALT- In the clinical study it showed incidence of elevations of ALT or AST above 5 times and 3 times the upper limit of normal (ULN) was 16% and 31%, respectively, in patients treated with SKYCLARYS. Monitor ALT, AST, and total bilirubin prior to initiation of SKYCLARYS, every month for the first 3 months of treatment, and periodically thereafter. Discontinue SKYCLARYS and repeat liver function tests as soon as possible, if there is transaminases increase to levels greater than 5 times the ULN, or greater than 3 times the ULN with evidence of liver dysfunction (e.g., elevated bilirubin).

Elevation of B-Type Natriuretic Peptide- Treatment with SKYCLARYS can cause elevation in BNP. Cardiomyopathy and cardiac failure are common in patients with Friedreich's ataxia. Patient should be monitored for signs and symptoms of fluid overload like sudden weight gain (3 pounds or more of weight gain in one day, or 5 pounds or more of weight gain in a week), peripheral edema, palpitations, and shortness of breath.

Abnormalities in the lipid profile - In a study 29% of patients treated with SKYLARCY had elevated cholesterol above the UNL, A total of 16% of patients treated with SKYCLARYS had an increase in low-density lipoprotein cholesterol and 6% of patients treated with SKYCLARYS had decreases in high-density lipoprotein cholesterol (HDL-C) from baseline compared to 4% of patients who received placebo.

Adverse Reactions

Clinical Trials Experience

In the clinical trials where SKYCLARYS 150 mg was taken once daily by 165 patients with Friedreich's ataxia, including 137 patients being exposed for at least 48 weeks, and 125 patients being exposed for at least 96 weeks. It showed SKYCLARYS had common adverse effects of transamnitis, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain. Furthermore, less adverse effects include back pain and spasm, rash and decreased appetite.

Postmarketing Experience

There is limited information regarding Omaveloxolone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Omaveloxolone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Omaveloxolone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Omaveloxolone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Omaveloxolone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Omaveloxolone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Omaveloxolone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Omaveloxolone in geriatric settings.

Gender

There is no FDA guidance on the use of Omaveloxolone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Omaveloxolone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Omaveloxolone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Omaveloxolone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Omaveloxolone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Omaveloxolone in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Omaveloxolone Administration in the drug label.

Monitoring

There is limited information regarding Omaveloxolone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Omaveloxolone and IV administrations.

Overdosage

There is limited information regarding Omaveloxolone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Omaveloxolone Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Omaveloxolone Mechanism of Action in the drug label.

Structure

There is limited information regarding Omaveloxolone Structure in the drug label.

Pharmacodynamics

There is limited information regarding Omaveloxolone Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Omaveloxolone Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Omaveloxolone Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Omaveloxolone Clinical Studies in the drug label.

How Supplied

There is limited information regarding Omaveloxolone How Supplied in the drug label.

Storage

There is limited information regarding Omaveloxolone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Omaveloxolone Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Omaveloxolone interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Omaveloxolone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Omaveloxolone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.