Now Approved: SYFOVRE (pegcetacoplan injection) – 3/2/23

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Email content sponsored by Apellis Pharmaceuticals, Inc. 


NOW APPROVED:


The first and only treatment proven to slow lesion growth rate in GA secondary to AMD1

SYFOVRE (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)


SELECT SAFETY INFORMATION

SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation.


Please see additional Important Safety Information below.


PRODUCT SPECIFICATIONS1:

How Supplied

SYFOVRE is supplied as a clear, colorless to light yellow aqueous solution. Each carton contains one single-dose glass vial. Each glass vial contains an overfill amount to allow for administration of a single 0.1mL dose of solution containing 15 mg of SYFOVRE

Packaging

Each SYFOVRE carton contains one single-dose glass vial

NDC Number

10-digit: 73606-020-01 and 11-digit: 73606-0020-01

WAC Pricing

$2,190 per vial

CPT Code2

67028: Intravitreal injection of a pharmacologic agent, separate procedure

Geographic Atrophy ICD-10-CM Diagnosis Codes3

Non-exudative age-related macular degeneration

Right Eye

Left Eye

Bilateral

Advanced atrophic without subfoveal involvement

H35.3113

H35.3123

H35.3133

Advanced atrophic with subfoveal involvement

H35.3114

H35.3124

H35.3134

This coding information is provided for informational purposes only, is subject to change, and should not be a substitute for independent clinical judgment when selecting diagnosis and/or reimbursement codes. Codes listed above may not be exhaustive of those required by payers.

INDICATION


SYFOVRE™ (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

 

IMPORTANT SAFETY INFORMATION


CONTRAINDICATIONS

  • SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation


WARNINGS AND PRECAUTIONS

  • Endophthalmitis and Retinal Detachments
  • 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.
  • Neovascular AMD
  • 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.
  • Intraocular Inflammation
  • 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.
  •  Increased Intraocular Pressure
  • 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.



ADVERSE REACTIONS

  • Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage.

 

Please see full Prescribing Information for more information.


References

1. Syfovre. Prescribing information. Apellis Pharmaceuticals, Inc.; 2023.

2. CPT 67028, under vitreous procedures on the posterior segment of the eye. AAPC. Accessed February 17, 2023. https://www.aapc.com/codes/cpt-codes/67028

3. ICD-10-CM code for nonexudative age-related macular degeneration H35.31. AAPC. Accessed February 17, 2023. https://www.aapc.com/codes/icd-10-codes/H35.31

APELLIS®, SYFOVRE™ and their respective

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Apellis Pharmaceuticals, Inc.

©2023 Apellis Pharmaceuticals, Inc. All Rights Reserved.

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