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danicopan (Voydeya)
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:
- start 150 mg PO TID with or without food
- can increase to 200 mg TID
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
General
hematologic agent
Database Correlations
PUBCHEM correlations
References
- HIGHLIGHTS OF PRESCRIBING INFORMATION
Voydeya (danicopan) tablets, for oral use
https://alexion.com/Documents/VOYDEYA_USPI.pdf
- Voydeya Risk Evaluation and Mitigation Strategy (REMS)
https://www.voydeyarems.com