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Empaveli
pegcetacoplan
Black Box Warnings .
Appropriate Use
restricted distribution program (EMPAVELI REMS) due to risk of serious infections; prescribers must enroll at 1-888-343-7073 or at www.empavelirems.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 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: INJ
Restricted Distribution in US
- [1-888-343-7073 or www.empavelirems.com for more info]
paroxysmal nocturnal hemoglobinuria
- [1080 mg SC 2x/wk]
- Info: if switching from eculizumab, initiate 1st pegcetacoplan dose 4wk before last eculizumab dose; if switching from ravulizumab, initiate 1st pegcetacoplan dose w/in 4wk after last ravulizumab dose; incr. dose to 1080 mg SC q3 days if LDH >2x ULN
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [no adjustment]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.