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SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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SELECT SAFETY INFORMATION
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SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation.
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Please see additional Important Safety Information below.
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Consider these key factors when choosing a treatment for your patients with Geographic Atrophy (GA):
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Of FDA-approved therapies for GA secondary to AMD
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ONLY SYFOVRE
is FDA approved for treatment beyond 12 months1-3
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Treat beyond 12 months with SYFOVRE
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ONLY SYFOVRE included every-other-month dosing from the start of clinical trials1,4
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Start every other month with SYFOVRE
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The recommended dose for SYFOVRE 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.1
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| INDICATION |
| SYFOVRE® (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). |
| IMPORTANT SAFETY INFORMATION |
| CONTRAINDICATIONS |
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SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation |
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| WARNINGS AND PRECAUTIONS |
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Endophthalmitis and Retinal Detachments
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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. |
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Retinal Vasculitis and/or Retinal Vascular Occlusion
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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. |
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Neovascular AMD
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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. |
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Intraocular Inflammation
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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. |
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Increased Intraocular Pressure
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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. |
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| ADVERSE REACTIONS |
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Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. |
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Please see full Prescribing Information for more information.
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AMD=age-related macular degeneration.
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References: 1. SYFOVRE (pegcetacoplan injection) [package insert]. Waltham, MA: Apellis Pharmaceuticals, Inc.; 2023. 2. Data on file. Apellis Pharmaceuticals, Inc. 3. IZERVAY [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; 2024. 4. A phase 3 safety and efficacy study of intravitreal administration of zimura (complement C5 inhibitor). ClinicalTrials.gov identifier: NCT04435366. Updated March 27, 2023. Accessed July 17, 2024.
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This content is sponsored by Apellis, and Specialty Practice Network has not independently reviewed or verified the information provided by Apellis. | | |