DANICOPAN TAB
Clinical Criteria Summary
Indication & Patient Population
- Add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Adults with confirmed PNH and clinically significant extravascular hemolysis (e.g., Hgb <9.5) despite stable anti-C5 treatment
Dosage & Administration
- 150mg to 200mg three times daily
- Available as 50mg and 100mg oral tablets
Contraindications
- Hypersensitivity to danicopan
- Unresolved serious infection caused by encapsulated bacteria (Strep. Pneumoniae, Neisseria meningitidis, or H. influenzae type B)
Warnings & Monitoring
- Risk of serious infections caused by encapsulated bacteria; complete or update vaccination at least 2 weeks prior to first dose unless risks of delaying therapy outweigh infection risk
- Not recommended in severe hepatic impairment (Child-Pugh class C)
- Insufficient data regarding risk of birth defects in pregnancy
- Cessation of breastfeeding recommended during treatment and for 3 days after final dose
- Hepatic enzyme elevations reported; baseline screening and monitoring recommended
- Monitor for hemolysis after cessation of therapy
Drug Interactions
- BCRP inhibitor: May increase plasma concentrations of BCRP substrates
- P-glycoprotein inhibitor: May increase plasma concentrations of P-gp substrates
- Rosuvastatin: Exposure significantly increased; dose should not exceed 10mg/day when used concomitantly
Adverse Reactions
- Headache (11%), vomiting (7%), pyrexia (7%), ALT increase (5%), hypertension (5%)