PEGCETACOPLAN INJ,SOLN

Clinical Criteria Summary

1080 mg by subcutaneous infusion twice weekly
Infusion duration: 30 minutes if using two infusion sides, or 60 minutes if using one infusion site
Patient can self-administer
Obtained via specialty pharmacy

Empaveli REMS program required for both prescribers and pharmacies
Prescribers must enroll in the REMS program
Providers must counsel patients on the risk of serious infection
Providers must provide patients with REMS educational materials
Patients must be vaccinated against encapsulated bacteria (Streptococcus pneumoniae, Neisseria meningitidis, Hemophilus influenzae) prior to initiation
Vaccination should occur at least 2 weeks before the first dose
Pharmacies must be REMS registered and submit daily data files to the REMS coordinator; use of the program’s specialty pharmacy is recommended due to administrative requirements

Hypersensitivity to pegcetacoplan or any component of the formulation
Patients not currently vaccinated against encapsulated bacteria (unless risks of delaying treatment outweigh the risk of infection)
Unresolved infection caused by encapsulated bacteria
Boxed warning for serious infections caused by encapsulated bacteria; adhere to ACIP recommendations for vaccinations in people with complement deficiencies
Live vaccines should not be administered
Consider restarting pegcetacoplan treatment if signs of hemolysis occur after discontinuation
Avoid breastfeeding during treatment and up to 40 days after the last dose

Complement C3 inhibitor indicated for the treatment of PNH
May be reasonable to consider in patients refractory to a complement C5 inhibitor, including those experiencing breakthrough hemolysis
European Medical Association approved for patients who remain anemic after at least three months of complement C5 inhibitor therapy

Geographic atrophy that is secondary to a condition other than age-related macular degeneration
Ocular or periocular infections
Active intraocular inflammation

Pregnancy should be excluded prior to receiving pegcetacoplan
Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 40 days after stopping treatment

Monitor for signs of neovascular AMD due to increased rates associated with clinical trial use
If anti-VEGF is required, administer separately from pegcetacoplan administration

Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
Specifically indicated for dry AMD (advanced late stage)

Intravitreal injection of 15 mg (0.1 mL of 150 mg/mL solution) to each affected eye
Dosing interval: Once every 25 to 60 days

Neovascular AMD: Associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (CNV); monitor for signs. If anti-VEGF therapy is required, administer separately from pegcetacoplan.
Retinal vasculitis: Post-marketing reports of occlusive and non-occlusive retinal vasculitis following injection; associated with intraocular inflammation. Discontinue use of 19-gauge filter needles; utilize kits containing 18-gauge needles.
Endophthalmitis and retinal detachments
Intraocular inflammation
Increased intraocular pressure

Women of childbearing potential: Use effective contraception during treatment and for 40 days after the last dose. Assess risks and benefits for women planning pregnancy.
Patients with a history of choroidal neovascularization (CNV) in the fellow eye have a greater risk of developing exudative AMD.

Use should be restricted to the treatment of GA secondary to AMD when no contraindications are present.

Active infection with Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae, or Streptococcus pneumoniae

Prescribed by a REMS registered VA or VA Community Care hematologist, oncologist, immunologist or genetic specialist
Laboratory-confirmed diagnosis of Paroxysmal Nocturnal Hemoglobinuria (PNH), as evidenced by detectable GPI-deficient hematopoietic clones (Type III PNH red blood cells (RBC)) via Flow Cytometry
Evidence of clinically significant hemolysis (e.g., Hemoglobin <10g/dL) despite 6 months of stable therapy with anti-C5 inhibitor (e.g., ravulizumab or eculizumab)
Complete or update vaccination for encapsulated bacteria, including Streptococcus pneumoniae and Neisseria meningitidis at least 2 weeks prior to the first dose of therapy according to current Advisory Committee on Immunization Practices (ACIP)