About omaveloxolone
Nrf2 pathway activator
Used for
- Treatment of Friedreich ataxia in adults and adolescents aged 16 years or older.
Usual adult dose
150 mg by mouth once daily, taken on an empty stomach.
Usual dose in children
Not established for children younger than 16 years.
Common side effects
- Elevated liver enzymes
- Headache
- Nausea
- Fatigue
Important warnings
- Monitor liver enzymes before treatment and during treatment.
- May cause fluid buildup and worsen heart failure.
- May increase blood pressure; monitor regularly.
- Avoid strong or moderate CYP3A4 inhibitors and inducers.
Pregnancy
May cause fetal harm based on animal studies; human pregnancy data are limited.
Breastfeeding
It is unknown whether omaveloxolone passes into breast milk; effects on infants are unknown.
Interactions
- Strong or moderate CYP3A4 inhibitors can raise omaveloxolone levels.
- Strong or moderate CYP3A4 inducers can lower omaveloxolone levels.
- Omaveloxolone can reduce effectiveness of CYP3A4-substrate medicines, including hormonal contraceptives.
AI-generated from general medical knowledge, not from this product's official leaflet. It may be incomplete or out of date. Not medical advice — ask a pharmacist or doctor before making any decision.