Version May 2024
Apellis Pharmaceuticals has provided an update on Syfovre (pegcetacoplan) ophthalmic injection kits and an update on the rare events of retinal vasculitis reported in real-world treatment with pegcetacoplan injections for geographic atrophy secondary to age-related macular degeneration. Retinal vasculitis is a rare side effect occurring at an estimated rate of 0.01% per injection. As part of a comprehensive investigation into real-world safety events, internal structural variations were identified in the specific 19-gauge × 1 ½-inch filter needle in certain pegcetacoplan ophthalmic injection kits. A causal relationship has not been established between the structural variations in the 19-gauge filter needle and retinal vasculitis; however, Apellis recommends that providers immediately discontinue use of any kits that contain the 19-gauge filter needle and use kits with 18-gauge filter needles. Apellis is now exclusively distributing kits with 18-gauge filter needles.
Further information can be found at https://investors.apellis.com/news-releases/news-release-details/apellis-provides-updates-injection-kits-and-rare-safety-events and https://syfovreecp.com/
Note: Ocular hypotensive medications may be administered if needed to lower intraocular pressure prior to administration.
Geographic atrophy: Intravitreal: 15 mg (0.1 mL) into affected eye(s) once every 25 to 60 days.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Intraocular inflammation: Hold pegcetacoplan; may resume once resolved.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%: Ophthalmic: Eye discomfort (10% to 13%), macular degeneration (7% to 12%)
1% to 10%: Ophthalmic: Anterior ischemic optic neuropathy (≤2%), conjunctival hemorrhage (8%), increased intraocular pressure (2% to 3%), intraocular inflammation (2% to 4%), punctate keratitis (3% to 5%), retinal hemorrhage (4% to 5%), secondary cataract (4%), vitreous detachment (4% to 6%), vitreous opacity (7% to 10%)
<1%: Ophthalmic: Anterior chamber eye hemorrhage, endophthalmitis, retinal detachment, retinal pigment epithelium tear
Postmarketing: Ophthalmic: Retinal vascular disease (retinal vasculitis) (Apellis Pharmaceuticals 2023)
Ocular or periocular infections; active intraocular inflammation.
Concerns related to adverse effects:
• Endophthalmitis/retinal detachment: Intravitreous injections are associated with endophthalmitis, retinal detachments, retinal tear, and hyphema. Use proper aseptic injection techniques. Instruct patients to report any signs of endophthalmitis (eg, eye pain or redness, photophobia, blurred vision) immediately; manage appropriately.
• Increased intraocular pressure: Following intravitreal injection, intraocular pressure may increase (acute); onset may be within minutes.
• Inflammation: Intraocular inflammation may occur; signs include anterior chamber cells, anterior chamber flare, iridocyclitis, iritis, uveitis, vitreal cells, and vitritis.
• Neovascular age-related macular degeneration: Neovascular (wet) age-related macular degeneration and choroidal neovascularization have been reported. If antivascular endothelial growth factor is required, administer separately from pegcetacoplan.
• Retinal vasculitis/retinal vascular occlusion: Retinal vasculitis and/or retinal vascular occlusion have been reported; may occur with the first intravitreal injection; typically occurs in the presence of intraocular inflammation and may result in severe vision loss. Instruct patients to report any changes in vision and discontinue treatment in patients who develop signs of retinal vasculitis and/or retinal vascular occlusion.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal [preservative free]:
Syfovre: 15 mg/0.1 mL (0.1 mL)
No
Solution (Syfovre Intravitreal)
15MG/0.1ML (per 0.1 mL): $2,628.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Intravitreal: For ophthalmic intravitreal injection only under controlled aseptic conditions. Each vial is used for the treatment of a single eye. Inject slowly until the full 0.1 mL is delivered. Should be administered using a 27 or 29-gauge 1/2-inch sterile needle. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before pegcetacoplan is administered to the other eye. Adequate anesthesia and a topical broad-spectrum antimicrobial agent should be administered prior to the procedure.
Geographic atrophy: Treatment of geographic atrophy secondary to age-related macular degeneration.
Pegcetacoplan may be confused with pegaptanib.
None known.
There are no known significant interactions.
Evaluate pregnancy status prior to use in patients who may become pregnant.
Patients who may become pregnant should use effective contraception during therapy and for 40 days after the last pegcetacoplan dose. Consider the risks and benefits of treatment prior to use in patients who intend to become pregnant.
Based on data from animal reproduction studies following SUBQ dosing, in utero exposure to pegcetacoplan may cause fetal harm. Systemic exposure following intravitreal injection is expected to be lower compared to a SUBQ dose.
It is not known if pegcetacoplan is present in breast milk following intravitreal injection.
Due to the potential for systemic absorption, the manufacturer recommends caution be used in patients who are breastfeeding.
Intraocular pressure using tonometry prior and immediately following injection; optic nerve head perfusion; signs/symptoms of endophthalmitis or retinal detachment; signs of neovascular age-related macular degeneration or choroidal neovascularization.
Pegcetacoplan is a complement inhibitor that acts by binding to complement protein C3 and its activation fragment C3b, thereby regulating the cleavage of C3 and the generation of downstream effectors of complement activation.
Distribution: Vd: ~1.85 L.
Metabolism: Metabolized by catabolic pathways into small peptides and amino acids.
Half-life elimination: 4.5 days.
Time to peak: 7 to 14 days.
Excretion: Clearance: 0.284 L/day.
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