Safety

Zaltrap (ziv-aflibercept) Injection

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

June 2016

Summary View

ADVERSE REACTIONS

Post Marketing Experience
  • (added) Cardiac disorders: Cardiac failure, Ejection fraction decreased

 

March 2016

Summary View

ADVERSE REACTIONS

Post Marketing Experience

Musculoskeletal and connective tissue disorders:

  • Osteonecrosis of the jaw

 

October 2013

Summary View

WARNINGS AND PRECAUTIONS

Proteinuria
  • Monitor proteinuria by urine dipstick analysis and/or urinary protein creatinine ratio (UPCR) for the development or worsening of proteinuria during Zaltrap therapy. Patients with a dipstick of =2+ for protein or a UPCR greater than 1 should undergo a 24-hour urine collection.

 

Page Last Updated: 07/07/2016
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