WARNINGS
Who should NOT receive SYFOVRE® (pegcetacoplan injection)?
Do not receive SYFOVRE if you have an infection or active swelling in or around your eye that may include pain and redness, or are allergic to pegcetacoplan or any ingredients in SYFOVRE. SYFOVRE can cause serious allergic reactions such as trouble breathing, tongue, face, lips, or mouth swelling, rashes, and hives.
What should I avoid while receiving SYFOVRE?
After an injection or an eye exam, your eyesight may temporarily be impaired. Do not drive or use machinery until your vision recovers
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.
USES
SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
HOW TO USE
Please call your healthcare provider for more information.
SYFOVRE can cause serious side effects:
Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment)
Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, small specks floating in your vision, or flashing lights
Severe inflammation of vessels in the retina which may result in severe vision loss. Call your healthcare provider right away if you have eye redness, light sensitivity, eye pain, or any change in vision including blurred, wavy/distorted vision, or flashing lights
Risk of developing wet AMD. You should be monitored for signs of wet AMD and you should report if you have any change in vision including blurred, wavy/distorted vision, black spots, or loss of central vision to your healthcare provider
Episodes of eye inflammation. You should report any symptoms including eye redness, light sensitivity, eye pain, small specks floating in your vision, or any changes in vision to your healthcare provider
Increase in eye pressure within minutes of the injection. Your healthcare provider will monitor this after each injection
What are the most common side effects of SYFOVRE?
Eye discomfort
Wet age-related macular degeneration
Small specks floating in vision
Blood in the white of the eye
These are not all the possible side effects of SYFOVRE. Tell your healthcare provider about any side effect that bothers you or does not go away.
Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
None.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store SYFOVRE in the refrigerator between 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F); Keep the vial in the original carton to protect from light.
NOTES
Medication Guide: revision date N/A
Prescribing Information: revision date 07/2025
Please call your healthcare provider for more information.
Before receiving SYFOVRE:
Tell your healthcare provider if any of the following applies to you:
If you have a history of seeing flashes of light or small specks floating in your vision and notice a sudden increase of size and number of these specks
If you have high pressure in the eye or glaucoma
Tell your healthcare provider about all of your medical conditions, including
If you are, or think you are pregnant, breastfeeding, or are planning to have a baby, ask your doctor for advice before taking this medicine
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
