IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or periocular infections, in patients with active
intraocular inflammation, and in patients with hypersensitivity to pegcetacoplan or any of the
excipients in SYFOVRE. Systemic hypersensitivity reactions (e.g., anaphylaxis, rash, urticaria) have
occurred.
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and
retinal detachments. Proper aseptic injection technique must always be used when administering
SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any
symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed
appropriately.
- Retinal Vasculitis and/or Retinal Vascular Occlusion
- Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular
inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of
SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who
develop these events. Patients should be instructed to report any change in vision without delay.
- Neovascular AMD
- In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or
choroidal neovascularization (12% when administered monthly, 7% when administered every other month
and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs
of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it
should be given separately from SYFOVRE administration.
- Intraocular Inflammation
- In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation
including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and
anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE.
- Increased Intraocular Pressure
- Acute increase in IOP may occur within minutes of any intravitreal injection, including with
SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed
as needed.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular
degeneration, vitreous floaters, conjunctival hemorrhage.
INDICATION
SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).