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U.S. Department of Health and Human Services

Safety

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Lucentis (Ranibizumab) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Summary View

 

WARNINGS AND PRECAUTIONS

 
Increases in Intraocular Pressure
  • Injection and post-injection (at 60 minutes) while being treated with Lucentis…
 
Thromboembolic Events
Diabetic Macular Edema
  • In a pooled analysis of Studies DME-1 and DME-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg Lucentis, 5.6% (14 of 250) with 0.3 mg Lucentis, and 5.2% (13 of 250) with control…
 
Fatal Events in DME Patients
  • A pooled analysis of Studies DME-1 and DME-2 showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg Lucentis, in 2.8% (7 of 250) of patients treated with 0.3 mg Lucentis, and in 1.2% (3 of 250) of control patients…