Omaveloxolone

This product is a semi-synthetic triterpenoid indicated for the treatment of Friedreich’s Ataxia in adults and adolescents aged 16 years and older.

【Recommended Dosage】

Prior to initiation and during treatment, assess alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, B-type natriuretic peptide (BNP), and lipid parameters. The recommended dosage is 150 mg taken orally once daily, on an empty stomach at least 1 hour before meals.

【Adverse Reactions】

The most common adverse reactions (incidence ≥20% and greater than placebo) are elevations in liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain.

【Pharmacological Action】

The exact mechanism of action of this product in treating Friedreich’s Ataxia is not fully established. Preclinical in vitro and in vivo animal studies and human data suggest that omaveloxolone activates the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway, which is involved in cellular responses to oxidative stress.

【Storage】

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).