Syfovre (pegcetacoplan/PF)

No dosing information is available for this tab.

Pegcetacoplan is administered as an intravitreal injection by a qualified physician. It is supplied in a single-dose vial as a 150 mg/mL solution for intravitreal injection.

Pegcetacoplan must be administered under aseptic conditions using a sterile, 1/2-inch, 29-gauge, thin-wall needle with Luer-lock hub or a sterile, 1/2-inch, 27-gauge needle with Luer-lock hub. Pegcetacoplan must be withdrawn from the vial using a sterile 5-micron filter needle and sterile 1 mL Luer-lock syringe with a 0.1 mL dose mark. Consult the prescribing information for detailed instructions on dose preparation. Ensure that the injection is administered immediately after dose preparation. Inject the dose volume of 0.1 mL slowly.

Each vial is for treatment of a single eye only. If both eyes require treatment, a new sterile vial should be used for the second eye, and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed between injections.

Do not shake the vial.

Store at 2--8degreesC in the original carton to protect from light. Keep the vial in the original carton at 20--25degreesC for at least 15 minutes (but not more than 8 hours) prior to injection.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been conducted with pegcetacoplan.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Ocular or periocular infections.

*Active intraocular inflammation.

*Hypersensitivity to pegcetacoplan or any excipients in the formulation.

• Ocular infection
• Ocular inflammation

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in at least 5% of patients receiving pegcetacoplan include ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage.

More Frequent

• Conjunctival hemorrhage
• Hypokalemia
• Infection
• Neovascular age-related macular degeneration

Less Frequent

• Biliary tract infection
• Gastrointestinal vascular ischemia
• Hypersensitivity pneumonitis
• Hypertension
• Ocular hypertension
• Posterior capsule opacification
• Punctate keratitis
• Retinal hemorrhage
• Vitreous detachment

Rare or Very Rare

• Anaphylaxis
• Facial edema
• Hypersensitivity drug reaction
• Meningococcemia
• Retinal vascular occlusion
• Retinal vasculitis

More Frequent

• Acute abdominal pain
• Cough
• Diarrhea
• Dizziness
• Fatigue
• Injection site sequelae
• Ocular discomfort
• Skin rash
• Upper respiratory infection
• Viral infection
• Vitreous floater

Less Frequent

• Abdominal distension
• Arthralgia
• Back pain
• Chest pain
• Drowsy
• Ecchymosis
• Endophthalmitis
• Epistaxis
• Erythema
• Fever
• Headache disorder
• Myalgia
• Pain in extremities
• Pain in oropharynx
• Peripheral edema
• Sepsis
• Symptoms of anxiety
• Thrombocytopenic disorder

Rare or Very Rare

• Urticaria

No enhanced messaging available.

The safety and efficacy of pegcetacoplan in pediatric patients have not been established.

Data on pegcetacoplan administration in pregnancy are not adequate to inform a drug-associated risk. Use during pregnancy may be considered following an assessment of risks and benefits.

Following ocular administration of pegcetacoplan, systemic exposure is low. Increases in abortion and stillbirth were observed following subcutaneous administration of pegcetacoplan to pregnant monkeys from the mid gestation period through birth. Systemic exposures to pegcetacoplan were 1040-fold greater than those observed in humans at the maximum recommended human ophthalmic dose (MRHOD). There were no adverse maternal or fetal effects observed in monkeys at systemic exposures approximately 470-fold higher than those observed in humans at the MRHOD.

It is unknown if intravitreal pegcetacoplan is excreted into human milk. It is not known whether there is potential for the drug to be absorbed and cause harm to the infant. Based on animal studies, the risk of clinically relevant exposure to the infant following maternal intravitreal administration appears to be minimal. Since many drugs are excreted into human milk, and there is potential for absorption and subsequent harm to infant growth and development, exercise caution when administering pegcetacoplan to a breastfeeding woman.

Pegcetacoplan was detected in the milk of lactating monkeys following subcutaneous injection at a concentration <1% of plasma levels; however, it was not detectable in the plasma of breast-fed infants.

The manufacturer states that no dosage adjustments are necessary based on age.

Approximately 97% of patients who received pegcetacoplan in clinical studies were >=65 years of age; approximately 72% were >=75 years of age. No differences in efficacy or safety of pegcetacoplan were observed with increasing age, and no dosage adjustments are recommended based on age.