Pegcetacoplan (Geographic Atrophy) (Local) (Monograph)

Drug class: Macular Degeneration Agents

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

Introduction

Complement inhibitor.

Uses for Pegcetacoplan (Geographic Atrophy) (Local)

Age-Related Macular Degeneration

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

Current guidelines from the American Academy of Ophthalmology (AAO) support use of antioxidant vitamin and mineral supplementation to slow progression of age-related macular degeneration in patients with intermediate or advanced disease. Specific role in therapy for intravitreal pegcetacoplan not yet established.

Pegcetacoplan (Geographic Atrophy) (Local) Dosage and Administration

General

Pretreatment Screening

Prior to injection, monitor for elevated intraocular pressure (IOP) using tonometry. Give ocular hypotensive medication if needed to lower IOP.

Patient Monitoring

Monitor IOP and perfusion of the optic nerve head following pegcetacoplan injection; provide appropriate management if needed.
Monitor for signs and symptoms of endophthalmitis or retinal detachment (e.g., eye pain, eye redness, photophobia, blurred vision).
Monitor for signs of retinal vasculitis and/or retinal vascular occlusion (e.g., change in vision).
Monitor for signs of neovascular age-related macular degeneration.

Premedication and Prophylaxis

Administer adequate anesthesia and apply a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface prior to injection.

Other General Considerations

Anti-vascular endothelial growth factor (anti-VEGF) therapy should be given separately from pegcetacoplan administration.

Administration

Intravitreal Administration

Administer via intravitreal injection by a qualified physician.

Supplied in a single-dose vial as a 150 mg/mL solution for intravitreal injection.

Administer 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. Withdraw pegcetacoplan 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 prescribing information for detailed instructions on dose preparation.

Inject dose volume of 0.1 mL slowly.

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

Do not shake vial.

Dosage

Adults

Age-Related Macular Degeneration

Intravitreal

15 mg (0.1 mL of the 150 mg/mL solution) as an intravitreal injection to each affected eye once every 25—60 days.

Special Populations

Hepatic Impairment

No specific dosage recommendations in hepatic impairment.

Renal Impairment

No specific dosage recommendations in renal impairment.

Geriatric Patients

Manufacturer states no dosage adjustments necessary based on age.

Cautions for Pegcetacoplan (Geographic Atrophy) (Local)

Contraindications

Ocular or periocular infections.
Active intraocular inflammation.

Warnings/Precautions

Endophthalmitis and Retinal Detachments

Endophthalmitis and detachment of the retina associated with intravitreal injections. Use proper aseptic injection technique during administration to minimize risk. Promptly report symptoms of endophthalmitis or retinal detachment and provide appropriate management.

Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion, usually with concomitant intraocular inflammation, reported. May occur with first dose and cause severe vision loss.

Discontinue pegcetacoplan in patients who develop these conditions. Promptly report any vision changes.

Neovascular Age-related Macular Degeneration

Increased rates of neovascular (wet) age-related macular degeneration or choroidal neovascularization observed.

Monitor for signs of neovascular age-related macular degeneration. Give anti-vascular endothelial growth factor (anti-VEGF) therapy separately from pegcetacoplan.

Intraocular Inflammation

Associated with episodes of intraocular inflammation (including vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, anterior chamber flare). May resume therapy after inflammation resolves.

Increased Intraocular Pressure (IOP)

Possible acute increase in IOP within minutes of injection. Monitor perfusion of the optic nerve head following injection and manage as needed.

Immunogenicity

Anti-pegcetacoplan peptide antibodies observed; effects on pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of pegcetacoplan unknown.

Specific Populations

Pregnancy

Data not adequate to inform a drug-associated risk. May consider use after assessment of risks and benefits. Systemic exposure low following ocular administration.

Lactation

Not known if excreted into human milk. Not known if potential exists for absorption and infant harm. Exercise caution when administering to a breastfeeding woman.

Females and Males of Reproductive Potential

Advise females of reproductive potential to use effective contraception during treatment and for 40 days following the final dose. In women who plan to become pregnant, use may be considered after assessment of risks and benefits.

Pediatric Use

Safety and efficacy not established.

Geriatric Use

No differences in efficacy or safety observed with increasing age. No dosage adjustments recommended based on age.

Hepatic Impairment

Pharmacokinetics not significantly altered in hepatic impairment (based on total bilirubin levels of 0.05—1.7 mg/dL, albumin levels of 2.96—5.38 g/dL, AST levels of 8.7—101 IU/L, and ALT levels of 5.9—136 IU/L).

Renal Impairment

Pharmacokinetics not significantly altered in renal impairment.

Common Adverse Effects

Adverse effects reported in ≥5% of patients: ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

Drug Interactions

Formal drug interaction studies not conducted.

Pegcetacoplan (Geographic Atrophy) (Local) Pharmacokinetics

Absorption

Bioavailability

Systemic exposure increases in a dose-proportional manner over the intravitreal dosage range of 4—20 mg.

Peak plasma concentrations attained a median of 7—14 days following intravitreal administration.

Special Populations

Pharmacokinetics not significantly altered by age (60—97 years) or gender.

Distribution

Extent

Not known if excreted into human milk.

Elimination

Metabolism

Expected to be metabolized via catabolic pathways into small peptides and amino acids.

Half-life

4.5 days.

Stability

Storage

Intravitreal

Solution for Intravitreal Injection

2—8°C in original carton to protect from light. Keep in original carton for ≥15 minutes (but ≤8 hours) at 20—25°C prior to injection.

Actions

Complement inhibitor.
Binds with high affinity to C3 complement protein and its activation fragment C3b.
Binding regulates C3 cleavage and generation of downstream effectors of complement activation.

Advice to Patients

Advise patients that pegcetacoplan injection increases the risk of neovascular age-related macular degeneration, endophthalmitis, retinal detachment, and retinal vasculitis with or without retinal vascular occlusion. Advise patients that if they experience eye redness, light sensitivity, eye pain, or changes in vision (including flashing lights, blurred vision, or metamorphopsia), they should seek immediate care with an ophthalmologist.
Inform patients that they may experience temporary visual disturbances due to either the intravitreal injection or the eye examination. Advise patients not to drive or operate machinery until visual function has sufficiently recovered.
Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.
Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed. Advise females of reproductive potential to use effective contraception during treatment and for 40 days following the final dose.
Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Pegcetacoplan for intravitreal injection is obtained through designated specialty distributors and specialty pharmacies. Contact manufacturer or consult the Syfovrewebsite for specific availability information.