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Zilbrysq
zilucoplan
Black Box Warnings .
Appropriate Use
restricted distribution program (Zilbrysq REMS) due to serious meningococcal infection risk; prescribers, pharmacies must be certified; 1-877-414-8353 or www.zilbrysqrems.com for more info
Serious Meningococcal Infection
incr. risk of serious infection caused by meningococcal bacteria; life-threatening and fatal cases have occurred with complement inhibitors; may become rapidly life-threatening or fatal if not recognized and treated early; complete or update vaccination for serogroups A, C, W, Y, and B at least 2wk before tx start, unless tx delay risks outweigh infection risk; follow ACIP recommendations for patients receiving a complement inhibitor; give antibacterial prophylaxis if tx must start <2wk after vaccination; patients at incr. risk for invasive disease even after vaccination; monitor for early infection signs/symptoms and evaluate immediately if infection suspected
Adult Dosing .
Dosage forms: INJ (pre-filled syringe): 16.6 mg per 0.416 mL, 23 mg per 0.574 mL, 32.4 mg per 0.81 mL
Restricted Distribution in US
- [1-877-414-8353 or www.zilbrysqrems.com for more info]
generalized myasthenia gravis
- [<56 kg]
- Dose: 16.6 mg SC qd; Info: for anti-acetylcholine receptor antibody positive patients
- [56-76.9 kg]
- Dose: 23 mg SC qd; Info: for anti-acetylcholine receptor antibody positive patients
- [>77 kg]
- Dose: 32.4 mg SC qd; Info: for anti-acetylcholine receptor antibody positive patients
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.