danicopan (Voydeya)
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Introduction
Tradename: Voydeya
Indications
- add-one therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in patients with paroxysmal nocturnal hemoglobinuria
Contraindications
- not effective as monotherapy
- prescribe only in combination with ravulizumab or eculizumab
Dosage
Tablets: 50 mg, 100 mg
Monitor
- assess serum transaminases before treatment initiation & periodically during treatment
- monitor lipid panel periodically during treatment
Adverse effects
- most common: headache (10%)
- hyperlipidemia
- serious adverse reactions were reported in 5% of patients
- pancreatitis, cholecystitis, hepatotoxicity
- no specific serious adverse reaction was reported in more than 1 patient
Drug interactions
- danicopan increases plasma concentrations of BCRP1 substrates
- danicopan increases plasma concentrations of P-glycoprotein substrates
- danicopan significantly increases rosuvastatin levels
- dose of rosuvastatin should not exceed 10 mg once daily when used with Voydeya
Mechanism of action
- danicopan is complement factor D inhibitor inhibitor
- danicopan is a breast cancer resistance protein (BCRP1) inhibitor
- danicopan is an inhibitor of P-glycoprotein
Notes
- Voydeya is only available through a restricted program call Voydeya REMS because of the risk of serious infections caused by encapsulated bacteria
- patients must be vaccinated against infections caused by encapsulated bacteria (Neisseria meningitidis serogroups A, C, W, Y, & B & Streptococcus pneumoniae) prior to starting therapy
- patients & providers are aware or early signs & symptoms of serious encapsulated bacterial infections & the need for immediate medical evaluation
- prescribers must be certified in the Voydeya REMS to prescribe to patients
- pharmacies must be certified in the Voydeya REMS to dispense to patients
More general terms
References
- ↑ HIGHLIGHTS OF PRESCRIBING INFORMATION Voydeya <TM> (danicopan) tablets, for oral use https://alexion.com/Documents/VOYDEYA_USPI.pdf
- ↑ Voydeya Risk Evaluation and Mitigation Strategy (REMS) https://www.voydeyarems.com