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Post-marketing data
The rates below include cases reported from date of approval (October 2019) through July 24, 2020.* These events have been reported in Germany, Japan, Portugal, Switzerland, the United Kingdom and the USA.
Adverse event† |
Post-marketing adverse event rates
|
|
Total of three events of interest |
10.13 per 10,000 injections |
|
Retinal vasculitis |
2.73 per 10,000 injections |
|
Retinal vascular occlusion§ |
2.64 per 10,000 injections |
|
Retinal vasculitis + retinal vascular occlusion† |
4.76 per 10,000 injections |
*Spontaneous post-marketing reporting systems have several limitations, which can include under-reporting, incompletely documented cases and cases without imaging information
†Event rates are discrete; there is no duplication between categories
‡For some, but not all of the reported adverse events, moderate or severe vision loss has been reported
§The term “retinal vascular occlusion” includes physician reports of ocular and retinal infarction and ischemia, retinal vascular (artery and vein) occlusion, stenosis, thrombosis, and embolism.
As part of an enhanced pharmacovigilance program, Novartis performed a cumulative review of post-marketing data with a data lock point of 30 Jun 2020. In this analysis, approximately 30% of cases reporting retinal vasculitis and/or retinal vascular occlusion also reported vision loss (as reported or assessed by Novartis based on reported visual acuity test results).