Omaveloxolone

FDA label

Read the full label on DailyMed ↗

Renal Undefined

Hepatic Mild (Child-Pugh A): 150 mg QD; Moderate (B): 100 mg QD, reduce to 50 mg QD if adverse reactions; Severe (C): avoid use

If strong/moderate CYP3A4 inhibitor unavoidable: reduce to 50/100 mg QD respectively with close monitoring; avoid strong/moderate CYP3A4 inducers

Instructions

• Take on empty stomach: at least 1 h before or 2 h after eating
• Swallow capsules whole (do not crush/chew), or open and sprinkle entire contents on 2 tbsp applesauce and take immediately; not with milk or orange juice; not for enteral feeding tubes
• Missed dose: skip; do not double next dose
• Obtain ALT/AST, bilirubin, BNP, and lipid panel before initiation and during treatment

Available strengths

• cap 50 mg

Cautions

• Aminotransferase elevations (ALT/AST >3x ULN in 31%): monitor ALT/AST/bilirubin monthly x3 months then periodically; discontinue if >5x ULN, or >3x ULN with liver dysfunction
• BNP elevation — may indicate cardiac failure (cardiomyopathy common in Friedreich's ataxia): check BNP at baseline; monitor for fluid overload (rapid weight gain, edema, palpitations, dyspnea)
• Lipid abnormalities (increased LDL-C, decreased HDL-C): monitor lipids periodically
• May reduce hormonal contraceptive efficacy — use non-hormonal/additional contraception during and 28 days after treatment

Adverse reactions

• Elevated liver enzymes (AST/ALT, 37%)
• Headache
• Nausea
• Abdominal pain
• Fatigue
• Diarrhea
• Musculoskeletal pain

Pregnancy No adequate human data; developmental toxicity in animals at exposures at or below clinical; pregnancy exposure registry available

Lactation No human data; present in rat milk; weigh benefits vs risk