Syfovre
Pronunciation: Sigh-fove-ree
Generic name: pegcetacoplan
Dosage form: intravitreal injection
Drug class: Miscellaneous ophthalmic agents
What is Syfovre?
Syfovre injection is used to treat geographic atrophy (GA), which is the dry, advanced form of age-related macular degeneration (AMD). Syfovre injection works to slow the growth of GA lesions and to help preserve vision by reducing more significant vision loss and blindness. Syfovre is given as an injection into the eye (intravitreal injection) every 25 to 60 days.
Syfovre injection contains the active ingredient pegcetacoplan, which is a complement inhibitor.
Syfovre injection received FDA approval on February 17, 2023, for the treatment of geographic atrophy secondary to age-related macular degeneration.
What is Geographic Atrophy?
Geographic atrophy lesions are areas in the retina that are damaged due to 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 that is most important for sharp vision. It is the progression of the lesion over the fovea that 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 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 side effects of Syfovre
Common Syfovre side effects may include eye discomfort, wet age-related macular degeneration, small specks floating in the vision, and blood in the white of the eye.
Serious side effects of Syfovre
Serious Syfovre side effects include:
Eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment)
- Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.
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 any symptoms (eg, visual distortion, deterioration in vision, black spots, loss of central vision) to your healthcare provider.
Episodes of eye inflammation
- You should report any symptoms (eg, pain or discomfort, redness, swelling, or sensitivity to light, small specks floating in your vision, 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.
These are not all the possible side effects of this medicine.
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.
Related/similar drugs
Vabysmo, Eylea, Izervay, ranibizumab ophthalmic, Lucentis, aflibercept ophthalmic, pegcetacoplan ophthalmic
Warning
You should NOT receive Syfovre 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 Syfovre?
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 Syfovre may 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.
Syfovre is given into each affected eye every 25 to 60 days; the frequency of your injections will be decided by your physician.
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
Usual Adult Syfovre 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.
What should I avoid while receiving Syfovre?
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.
Syfovre Prescribing Information
Review the Syfovre Prescribing Information for more detailed information about this injection. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.
Storage
- Refrigerate Syfovre 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.
Manufacture
Apellis Pharmaceuticals, Inc. 100 Fifth Avenue Waltham, MA 02451
Popular FAQ
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
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.