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pegcetacoplan (Empaveli, Syfovre)
Indications:
- treatment of adults with paroxysmal nocturnal hemoglobinuria
- geographic atrophy secondary to age-related macular degeneration (Syfovre) [2]
Contraindications:
- Syfovre: ocular or periocular infections or active intraocular inflammation [2]
Dosage:
- 1,080 mg twice weekly
- may be given in addition to eculizumab
- Syfovre injection administered every 25-60 days for geographic atrophy [2]
Adverse effects:
- serious infections caused by encapsulated bacteria
- life-threatening meningococcal infections
- viral infections
- respiratory tract infection
- diarrhea
- abdominal pain
Mechanism of action:
- binds to complement-C3
Notes:
- available only through a restricted program under a risk evaluation & mitigation strategy (REMS)
- Syfovre cost: $2190 per vial [2]
General
hematologic agent
ophthalmic agent (eyedrops)
References
- FDA Drug Approval. May 18, 2021
FDA approves new treatment for adults with serious rare blood disease
https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-new-treatment-adults-serious-rare-blood-disease
- Marcus A
FDA OKs First Drug for Geographic Atrophy, a Major Cause of Adult Blindness.
Medscape. February 17, 2023
https://www.medscape.com/viewarticle/988460