Omaveloxolone
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)
There is limited information regarding Omaveloxolone FDA-Labeled Indications and Dosage (Adult) in the drug label.
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
There is limited information regarding Omaveloxolone Contraindications in the drug label.
Warnings
There is limited information regarding Omaveloxolone Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Omaveloxolone Clinical Trials Experience in the drug label.
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.