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Voydeya
danicopan
Black Box Warnings .
Appropriate Use
restricted distribution program (VOYDEYA REMS) due to risk of serious infections; prescribers and pharmacies must be certified and enroll at 1-888-765-4747 or www.voydeyarems.com
Serious Infections
may occur, esp. those caused by encapsulated bacteria, such as Streptococcus pneumoniae, Neisseria meningitidis, and Haemophilus influenzae type B; life-threatening and fatal cases have occurred w/ complement inhibitors; may become rapidly life-threatening or fatal if not recognized and treated early; complete or update vaccination for encapsulated bacteria, specifically Streptococcus pneumoniae and Neisseria meningitidis at least 2wk before tx start, unless tx delay risks outweigh serious infection risk; give antibacterial prophylaxis if urgent tx indicated in pt not up to date w/ vaccines, and admin. vaccines ASAP; comply w/ ACIP recommendations for vaccinations against encapsulated bacteria in pts receiving a complement inhibitor; revaccinate per ACIP recommendations, considering tx duration; pts at incr. risk for invasive dz caused by encapsulated bacteria even if antibodies developed after vaccination; monitor for early signs of serious infection and eval. immediately if infection suspected
Adult Dosing .
Dosage forms: TAB: 50 mg, 100 mg
Restricted Distribution in US
- [1-888-765-4747 or www.voydeyarems.com]
paroxysmal nocturnal hemoglobinuria, add-on tx
- [150-200 mg PO TID]
- Start: 150 mg PO TID; Info: for pts w/ extravascular hemolysis; use w/ eculizumab or ravulizumab; may incr. dose to 200 mg PO TID if Hgb not incr. by >2 g/dL after 4wk, if transfusion required in previous 4wk, or if clinically warranted to achieve Hgb response
renal dosing
- [see below]
- renal impairment: not defined; Info: caution advised if eGFR <30
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class C: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.