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Fabhalta
iptacopan
Black Box Warnings .
Appropriate Use
restricted distribution program (FABHALTA REMS) due to risk of serious infections caused by encapsulated bacterial; prescribers and pharmacies must be certified and enroll at 1-833-993-2242 or www.FABHALTA-REMS.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: CAP: 200 mg
Restricted Distribution in US
- [1-833-993-2242 or www.FABHALTA-REMS.com for more info]
paroxysmal nocturnal hemoglobinuria
- [200 mg PO bid]
- Info: if switching from eculizumab, initiate 1st iptacopan dose w/in 1wk after last eculizumab dose; if switching from ravulizumab, initiate 1st iptacopan dose w/in 6wk after last ravulizumab dose; do not open/crush/chew cap
IgA nephropathy, primary
- [200 mg PO bid]
- Info: for pts w/ rapid progression risk; do not open/crush/chew cap
complement 3 glomerulopathy
- [200 mg PO bid]
- Info: do not open/crush/chew cap
renal dosing
- [see below]
- eGFR >25: no adjustment; eGFR <25: not defined
- 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.