Syfovre
Pronunciation: Sigh-fove-ree
Generic name: pegcetacoplan
Dosage form: intravitreal injection
Drug class: Miscellaneous ophthalmic agents
What is Syfovre?
Syfovre is used to treat a form of macular degeneration called geographic atrophy (GA) to help preserve vision by slowing vision loss and, therefore, blindness. Syfovre injection works by slowing the growth of GA lesions by controlling part of the immune system that is overactive. It is given as an injection into the eye (intravitreal injection) every 25 to 60 days.
Syfovre FDA approval was received on February 17, 2023, for the treatment of geographic atrophy secondary to age-related macular degeneration for the company Apellis. Syfovre injection contains the active ingredient pegcetacoplan, which is a complement inhibitor.
Syfovre injection works by controlling part of the immune system called the complement system. In age-related macular degeneration, the complement system is overactive, which may cause damage to the retinal cells and progression of geographic atrophy. Syfovre works (mechanism of action) by binding and inhibiting a protein called C3, which regulates complement overactivation, and this helps slow vision loss.
What is Geographic Atrophy?
Geographic atrophy lesions are damaged areas in the retina caused by age-related macular degeneration. Over time, the geographic atrophy lesion(s) become larger and can spread to the center of the retina (fovea), which is the area most important for sharp vision. The progression of the lesion over the fovea causes vision loss and blindness.
How does Syfovre work?
Syfovre works (mechanism of action) by inhibiting C3, a protein in the complement system, which is part of the immune system. In AMD, the complement system is overactive and is involved in the damage of retinal cells. When Syfovre injection inhibits C3, it controls the complement system, which slows the damage to the retinal cells and the progression of geographic atrophy.
Syfovre side effects
Common Syfovre side effects
Common side effects of Syfovre are eye pain, irritation, or feeling like something is in your eye, an eye condition called neovascular age-related macular degeneration, seeing flashes of light or "floaters" in your vision, or bleeding in the white part of the eye. These side effects occurred in 5% or more of patients.
Serious Syfovre side effects
Allergic reactions: Get emergency medical help if you have signs of an allergic reaction with symptoms of hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
Some other serious side effects may occur right after the injection. Tell your doctor right away if you have:
- signs of eye infection - swelling, severe discomfort, crusting or drainage;
- severe eye redness or pain;
- eyes being more sensitive to light;
- blurred or cloudy vision; or
- changes in your vision, seeing flashes of light.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Warning
You should NOT receive this injection if you:
- have an infection in or around your eye
- have any active swelling around or in your eye that may include pain and redness
What should I tell my doctor before receiving this medicine?
Tell your healthcare provider if:
- If in the past you have seen flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.
- If you have high eye pressure or if you have glaucoma.
Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant.
Women able to become pregnant should use effective contraception methods to prevent pregnancy during treatment with this medicine and for 40 days after the last dose. For women planning to become pregnant, the use of this medicinemay be considered following an assessment of the risks and benefits.
Breastfeeding
Ask your doctor for advice before taking this medicine. If you are breastfeeding or planning to breastfeed, your doctor will talk to you about the best way to feed your baby.
How is Syfovre administered?
Syfovre is given as an injection into the vitreous (the soft gel in the middle of your eye) by a qualified physician.
The injection is given into each affected eye every 25 to 60 days; the frequency of your injections will be decided by your physician.
You will need to have frequent eye examinations before and after receiving this injection.
Syfovre cost
The cost of this medicine may vary depending on your insurance plan. You may also be eligible for a financial assistance program.
Syfovre Dosing Information
The usual Adult Dose is 15 mg (0.1 mL of 150 mg/mL solution) given as a single dose. Any excess volume should be disposed of. The injection should be given immediately after the dose has been prepared.
Comments:
- Monitor the patient for elevated intraocular pressure (IOP) using tonometry before and after the intravitreal injection; if needed, ocular hypotensive medication can be given to lower the IOP.
- Administer adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface prior to the injection.
- Do not use the filter needle for injection.
- Each vial should only be used for the treatment of a single eye.
Related/similar drugs
Eylea, Vabysmo, aflibercept ophthalmic, Lucentis, Izervay, ranibizumab ophthalmic, pegcetacoplan ophthalmic
What should I avoid while receiving this medicine?
Syfovre injection may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.
Storage
- Refrigerate between 2°C to 8°C (36°F to 46°F). Store the vial in the original carton to protect from light.
- Do not use beyond the expiration date on the carton.
- Do not shake.
What other drugs will affect this medicine?
Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact. Tell your doctor about all your current medicines, including prescription and over-the-counter medicines, vitamins, and herbal products.
Company
Syfovre Apellis Pharmaceuticals, Inc. 100 Fifth Avenue Waltham, MA 02451
Popular FAQ
How do Izervay and Syfovre compare?
Izervay (avacincaptad pegol) and Syfovre (pegcetacoplan) are injectable treatments for geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that causes progressive and irreversible vision loss. Continue reading
Is Syfovre covered by Medicare?
Medicare Part B covers eye disease treatment Syfovre if you have geographic atrophy (GA) secondary to age-related macular degeneration (AMD). After you meet your Part B deductible, your cost is 20% of the Medicare-approved amount for the drug and services. Check with your Medicare plan for coverage details. Continue reading
How effective is Syfovre for macular degeneration?
In two 24-month long clinical studies, monthly eye injections with Syfovre slowed geographic atrophy lesion growth rate (retinal cell loss) by 18% to 22%. Injections given every other month slowed the lesion growth rate by 17% to 18%. Syfovre is used to treat geographic atrophy secondary to age-related macular degeneration. Continue reading
References
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Professional resources
- Syfovre Injection prescribing information
- Pegcetacoplan (Geographic Atrophy) (Local) (AHFS Monograph)
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.