Syfovre
(Pegcetacoplan)Dosage & Administration
The recommended dose for SYFOVRE is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days. (
The recommended dose for SYFOVRE is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.
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Syfovre Prescribing Information
Dosage and Administration, Preparation for Administration (
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Contraindications, Hypersensitivity (SYFOVRE is contraindicated in patients with hypersensitivity to pegcetacoplan or to any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred in patients treated with SYFOVRE [see Adverse Reactions (6.2)] . | 12/2024 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SYFOVRE is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The recommended dose for SYFOVRE is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days. (
The recommended dose for SYFOVRE is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.
Injection: 150 mg/mL, clear, colorless to light yellow aqueous solution in a single-dose vial for administration of a single 0.1 mL dose.
There are no adequate and well-controlled studies of SYFOVRE administration in pregnant women to inform a drug-associated risk. The use of SYFOVRE may be considered following an assessment of the risks and benefits.
Systemic exposure of SYFOVRE following ocular administration is low
SYFOVRE is administered directly into the vitreous to exert local effects in the eye.
Following repeat intravitreal administration of pegcetacoplan at a dose of 15 mg, geometric mean (%CV) serum Cmaxvalue at steady state was 2.2 μg/mL (28.7%) and 1.5 μg/mL (58.1%) for GA patients dosed monthly and every other month, respectively. The steady state geometric mean (%CV) serum trough concentrations were 1.0 μg/mL (52.3%) and 0.2 μg/mL (89.6%) for patients treated monthly and every other month, respectively.
Following intravitreal administration of pegcetacoplan, the systemic median Tmaxof pegcetacoplan is between 7 and 14 days. Following intravitreal treatment, systemic exposure of pegcetacoplan increases approximately proportionally over a dosage range from 4 to 20 mg.
The geometric mean (95%CI) volume of distribution of pegcetacoplan is approximately 1.85 L (1.62 - 2.12) in patients with GA following intravitreal administration.
The estimated geometric mean (%CV) of clearance (CL) is 0.284 L/day (21.1%) and geometric mean half-life of elimination (t1/2) is 4.5 days (21.1%) in patients with GA.
Pegcetacoplan is expected to be metabolized into small peptides and amino acids by catabolic pathways.
There were no clinically significant differences on the pharmacokinetics of pegcetacoplan intravitreal administration based on age (60 to 97 years old), gender, renal impairment, and hepatic function as evaluated by total bilirubin (0.05-1.7 mg/dL), albumin (2.96-5.38 g/dL), aspartate aminotransferase (8.7-101 IU/L), or alanine aminotransferase (5.9-136 IU/L).
In embryofetal development studies, subcutaneous administration of pegcetacoplan to pregnant cynomolgus monkeys from the mid gestation period through birth produced increased incidences of abortions and stillbirths at doses of 28 mg/kg/day [approximately 1040-fold higher than the MRHOD based on exposure (AUC)]. Pegcetacoplan was not maternally toxic and did not produce adverse embryofetal effects in the monkey at subcutaneous doses of 7 mg/kg/day. (approximately 470-fold higher than the MRHOD). No developmental effects were observed in infants up to 6 months postpartum. Minimal systemic exposure to pegcetacoplan (less than 1%, not pharmacologically significant) was detected in fetuses from monkeys treated subcutaneously with 28 mg/kg/day from the period of organogenesis through the second trimester.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
- Ocular or Periocular Infections ()
4.1 Ocular or Periocular InfectionsSYFOVRE is contraindicated in patients with ocular or periocular infections
[see Warnings and Precautions (5.1)]. - Active Intraocular Inflammation ()
4.2 Active Intraocular InflammationSYFOVRE is contraindicated in patients with active intraocular inflammation.
- Hypersensitivity ()
4.3 HypersensitivitySYFOVRE is contraindicated in patients with hypersensitivity to pegcetacoplan or to any of the excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have occurred in patients treated with SYFOVRE[see Adverse Reactions (6.2)].