November 2023 Syfovre Label Change Comes After Earlier Reports of Eye Inflammation and Severe Vision Loss
We have been writing about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects since July 2023. This latest article is about the November 2023 Syfovre label change that adds new warnings about retinal vasculitis and/or retinal vascular occlusion associated with Syfovre injections.
For background, here is a general Syfovre timeline bringing us up to the present time:
- Syfovre (pegcetacoplan injection) was approved by the FDA in February 2023 as a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD);
- In July 2023 the first reports of retinal vasculitis associated with Syfovre became public. In turn, Apellis Pharmaceuticals launched an investigation for retinal vasculitis cases and other eye-related side effects; and,
- Then Apellis suggested in August 2023 that an issue related to certain injection kits used for Syfovre may be a possible cause of eye inflammation sometimes leading to retinal vasculitis and severe vision loss, Apellis urging doctors to switch to a different injection kit.
With this November 2023 Syfovre label change it now seems that the retinal vasculitis cases associated with Syfovre use are due to the drug itself and not the injection kits, as had been suggested by Apellis.
The two newly added subsections to the Syfovre Prescribing Information document "Revised: 11/2023" version (accessed 12/4/23) with warnings about retinal vasculitis are set forth below:
5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE [see Adverse Reactions (6.2)]. 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.
6.2 Postmarketing Experience
The following adverse reactions have been identified during postapproval use of SYFOVRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye disorders: retinal vasculitis with or without retinal vascular occlusion.
Strictly Confidential, No Obligation.
Here is a list of our earlier Drug Injury Watch articles about Syfovre drug safety developments having to do with retinal vasculitis cases and other eye-related side effects:
Syfovre Patients Eye Side Effects Cases at Iowa Clinic: Important 2023 AAO Meeting Presentation -- A Syfovre Case of Hemorrhagic Occlusive Vasculitis-type Inflammation With Continued Blindness Is Reported [11/10/2023]
Apellis Updates Number of Syfovre Retinal Vasculitis Cases But Provides No Further "Explanation" -- On That Aspect, in August 2023 Apellis Asked Doctors to Stop Using Syfovre Injection Kits With a 19-gauge Filter Needle [10/13/2023]
Syfovre Adverse Reaction Cases: Updated Number of Patients With Retinal Vasculitis, Timeline of Events -- Additional Information from Apellis and the American Society of Retina Specialists About Ongoing Syfovre Safety Issues [8/17/2023]
Syfovre Retinal Vasculitis And Severe Intraocular Inflammation Cases Reported By Ophthalmologists -- A July 2023 "Dear Doctor" Letter From Apellis Acknowledges This Developing Syfovre Safety Signal Situation [7/28/2023]
Eye Drug Syfovre Side Effects: Occlusive Retinal Vasculitis, Eye Inflammation, Vision Loss, And Blindness -- American Society of Retinal Specialists (ASRS) July 2023 Warning Letter About Adverse Events Reports Associated With Syfovre [7/19/2023]
We are investigating Syfovre drug injury lawsuits for patients who developed retinal vasculitis, eye inflammation, severe vision loss, or blindness after receiving their Syfovre injection. To be clear, these lawsuits would be filed against Apellis Pharmaceuticals, the drug company responsible for Syfovre -- not the patient's eye doctor.