SYFOVRE Dosage & Rx Info | Uses, Side Effects

Syfovre Generic Name & Formulations

Legal Class

General Description

Pegcetacoplan 150mg/mL; soln for intravitreal inj.

Pharmacological Class

Complement inhibitor.

How Supplied

Single-dose vial—1

Manufacturer

Apellis Pharmaceuticals

Generic Availability

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.

Syfovre Indications

Indications

Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Syfovre Dosage and Administration

Adult

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.

Children

Not established.

Syfovre Contraindications

Contraindications

Ocular or periocular infection. Active intraocular inflammation.

Syfovre Boxed Warnings

Not Applicable

Syfovre Warnings/Precautions

Warnings/Precautions

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. Discontinue if retinal vasculitis and/or retinal vascular occlusion occurs. 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.

Syfovre Pharmacokinetics

Absorption

Systemic median T_max is between 7–14 days. The systemic exposure of pegcetacoplan increases approximately proportionally over a dosage range from 4–20 mg.

Distribution

Geometric mean (95% CI) volume of distribution: ~1.85 L (1.62–2.12) in patients with GA following intravitreal administration.

Metabolism

Catabolic pathways.

Elimination

Estimated geometric mean (%CV) of clearance (CL): 0.284 L/day (21.1%). Geometric mean half-life: 4.5 days (21.1%).

Syfovre Interactions

Interactions

If anti-VEGF is required, give separately from Syfovre administration.

Syfovre Adverse Reactions

Adverse Reactions

Ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Syfovre Clinical Trials

See Literature

Syfovre Note