Syfovre Generic Name & Formulations
Mechanism of Action
Pegcetacoplan binds to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation.
Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Syfovre Dosage and Administration
See full labeling. Each vial is for use in a single eye. Give by intravitreal inj to each affected eye. 15mg (0.1mL of 150mg/mL solution) once every 25 to 60 days.
Ocular or periocular infection. Active intraocular inflammation.
Syfovre Boxed Warnings
Must be administered by a qualified physician. Monitor for elevated IOP prior to initiation and following inj (may give ocular hypotensive meds if needed). Monitor for endophthalmitis, retinal detachments, neovascular AMD, and perfusion of the optic nerve head following inj. Risk for intraocular inflammation; may resume after resolution. Advise females of reproductive potential to use effective contraception during and for 40 days after the last dose. Pregnancy. Nursing mothers.
Systemic median Tmax is between 7 and 14 days. The systemic exposure of pegcetacoplan increases approximately proportionally over a dosage range from 4–20 mg.
The geometric mean (95% CI) volume of distribution: ~1.85 L (1.62–2.12) in patients with GA following intravitreal administration.
Estimated geometric mean (%CV) of clearance (CL): 0.284 L/day (21.1%). Geometric mean half-life: 4.5 days (21.1%).
If anti-VEGF is required, give separately from Syfovre administration.
Syfovre Adverse Reactions
Ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage; intraocular inflammation.
Syfovre Clinical Trials
Syfovre Patient Counseling