SYFOVRE- pegcetacoplan injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

Pegcetacoplan (UNII: TO3JYR3BOU) (Pegcetacoplan - UNII:TO3JYR3BOU)

Disponível em:

Apellis Pharmaceuticals, Inc.

Via de administração:

INTRAVITREAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

SYFOVRE is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). SYFOVRE is contraindicated in patients with ocular or periocular infections [see Warnings and Precautions (5.1)] . SYFOVRE is contraindicated in patients with active intraocular inflammation. Risk Summary 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 [see Clinical Pharmacology (12.3)] . Subcutaneous administration of pegcetacoplan to pregnant monkeys from the mid gestation period through birth resulted in increased incidences of abortions and stillbirths at systemic exposures 1040-fold higher than that observed in humans at the maximum recommended human ophthalmic dose (MRHOD) of SYFOVRE (based on the area under the curve (AUC) systemically measured levels). No adverse maternal or fetal effects were observed in monkeys at systemic exposures approximately 470-fold higher than that observed in humans at the MRHOD (see Data) . 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. Data Animal Data 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. Risk Summary It is not known whether intravitreal administered pegcetacoplan is secreted in human milk or whether there is potential for absorption and harm to the infant. Animal data suggest that the risk of clinically relevant exposure to the infant following maternal intravitreal treatment is minimal (see Data) . Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when SYFOVRE is administered to a nursing woman. Data Animal Data Pegcetacoplan was detectable in milk of lactating monkeys after subcutaneous administration at less than 1% concentration of serum levels but was not detectable in the serum of nursing infants. Contraception Females It is recommended that women of childbearing potential use effective contraception methods to prevent pregnancy during treatment with intravitreal pegcetacoplan. Advise female patients of reproductive potential to use effective contraception during treatment with SYFOVRE and for 40 days after the last dose. For women planning to become pregnant, the use of SYFOVRE may be considered following an assessment of the risks and benefits. The safety and effectiveness of SYFOVRE in pediatric patients have not been established. In clinical studies, approximately 97% (813/839) of patients randomized to treatment with SYFOVRE were ≥ 65 years of age and approximately 72% (607/839) were ≥ 75 years of age. No significant differences in efficacy or safety were seen with increasing age in these studies. No dosage regimen adjustment is recommended based on age.

Resumo do produto:

SYFOVRE (pegcetacoplan injection) is supplied as a clear, colorless to light yellow aqueous solution. Each SYFOVRE carton (NDC 73606-020-01) contains one single-dose glass vial. Each glass vial contains an overfill amount to allow for administration of a single 0.1 mL dose of solution containing 15 mg of SYFOVRE. Refrigerate SYFOVRE between 2°C to 8°C (36°F to 46°F). Store the vial in the original carton to protect from light. Do not use beyond the expiration date on the carton. Do not shake.

Status de autorização:

New Drug Application

Características técnicas

SYFOVRE- PEGCETACOPLAN INJECTION, SOLUTION
APELLIS PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYFOVRE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYFOVRE.
SYFOVRE ™ (PEGCETACOPLAN INJECTION), FOR INTRAVITREAL USE
INITIAL U.S. APPROVAL: 2021
RECENT MAJOR CHANGES
Warnings and Precautions, Retinal Vasculitis and/or Retinal Vascular
Occlusion (5.2)
11/2023
INDICATIONS AND USAGE
SYFOVRE is a complement inhibitor indicated for the treatment of
geographic atrophy (GA) secondary to
age-related macular degeneration (AMD). (1)
DOSAGE AND 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.
(2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 150 mg/mL in a single-dose vial. (3)
CONTRAINDICATIONS
Ocular or Periocular Infections (4.1)
Active Intraocular Inflammation (4.2)
WARNINGS AND PRECAUTIONS
Endophthalmitis and Retinal Detachments (5.1)
Retinal Vasculitis and/or Retinal Vascular Occlusion (5.2)
Neovascular AMD (5.3)
Intraocular inflammation (5.4)
Increased Intraocular Pressure (5.5)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥5%) are ocular discomfort,
neovascular age-related macular
degeneration, vitreous floaters, and conjunctival hemorrhage. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT APELLIS
PHARMACEUTICALS, INC. AT 1-833-
866-3346 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2023
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Recommended Dosage
2.3 Preparation for Administration
2.4 Injection Procedure
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
4.2 Active Intraocular Inflammation
5 WARNINGS AND PRECAUTIONS
5.1 Endophthalmitis and Retinal Detachments
5.2 Retinal Vasculitis and/or Retinal Va