Omaveloxolone

　　【Indications】

　　This product is a semi synthetic triterpenoid compound suitable for the treatment of Friedreich ataxia in adults and adolescents aged 16 and above.

　　Recommended dosage

　　Obtain alanine aminotransferase(ALT),aspartate aminotransferase(AST),bilirubin,B-type natriuretic peptide(BNP),and blood lipid parameters before starting this product and during treatment.

　　The recommended dosage is 150mg,taken orally once a day,on an empty stomach at least 1 hour before meals.

　　Adverse reactions

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

　　Pharmacological effects

　　The exact mechanism of action of this product for treating patients with Friedreich ataxia is not yet clear.

　　Studies on animals and humans both in vitro and in vivo have shown that oxacin can activate the nuclear factor(erythroid derived 2)-like 2(Nrf2)pathway.The Nrf2 pathway is involved in the cellular response to oxidative stress.

　　[Storage]

　　The storage temperature ranges from 20°C to 25°C(68°F to 77°F),with allowable fluctuations between 15°C to 30°C(59°F to 86°F).