Syfovre
Pronunciation: Sigh-fove-ree
Generic name: pegcetacoplan
Dosage form: intravitreal injection
Drug class: Miscellaneous ophthalmic agents
What is Syfovre?
Syfovre (pegcetacoplan) injection is used to treat geographic atrophy (GA), the dry, advanced form of age-related macular degeneration (AMD). Syfovre helps to preserve vision for longer by slowing the growth of GA lesions. It does not cure GA, but it can help slow down the decline in vision.
Syfovre works by controlling the overactive immune response that damages retinal cells. Syfovre's mechanism of action is as a complement inhibitor.
Syfovre is administered as an injection into the eye (intravitreal injection) every 25 to 60 days.
Syfovre FDA approval was granted on February 17, 2023, for the indication of geographic atrophy secondary to age-related macular degeneration.
How does Syfovre work?
Syfovre works (mechanism of action) by inhibiting C3, a key protein that is part of the body’s immune system (the complement system). In age-related macular degeneration (AMD), the complement system becomes overactive and is involved in damaging the retina. By blocking C3, Syfovre helps to regulate the complement system, reducing damage to retinal cells and slowing the progression of geographic atrophy.
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
How effective is Syfovre?
The Phase 3 clinical trials, OAKS and DERBY, demonstrated that Syfovre significantly slowed geographic atrophy growth over 24 months compared to placebo treatment.
OAKS Trial (NCT03525613)
Geographic atrophy growth was slowed by:
-
22% for monthly Syfovre injections (-0.87 mm²/24 months).
- 18% for every-other-month injections (-0.72 mm²/24 months).
DERBY Trial (NCT03525600)
Geographic atrophy growth was slowed by:
- 18% for monthly injections (-0.73 mm²/24 months).
- 17% for every-other-month injections (-0.70 mm²/24 months).
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.
Related/similar drugs
Who should not have this injection?
You should NOT receive this injection if you have:
- An infection in or around your eye.
- Any active swelling around or in your eye that may include pain and redness.
- Hypersensitivity or allergy to the active ingredient or inactive ingredients.
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.
Your retina specialist will numb your eye first with a topical anesthetic, so the injection is not painful but you may feel some pressure during the injection.
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 dosing information
The recommended Syfovre dose for is 15 mg (0.1 mL of 150 mg/mL solution) administered by intravitreal injection to each affected eye once every 25 to 60 days.
General dosing information
- 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 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.
Syfovre J code
Syfovre J code is J2781.
J codes are used for medicines that are not taken orally and include injections, inhalations chemotherapies.
Syfovre Package Insert
HCPs and patients often use the Syfovre Package Insert (PI) for more detailed information about this medicine. The Package Insert contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). 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.
The Package Insert is sometimes called Syfovre Prescribing Information (PI) or FDA label.
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
- Complement C3 Inhibitor Pegcetacoplan for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Phase 2 Trial
- Syfovre Package Insert - FDA
- Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials
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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.