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Label Changes for:

Zaltrap (ziv-aflibercept) Injection

June 2016

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

June 2016

ADVERSE REACTIONS

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

 

March 2016

ADVERSE REACTIONS

Post Marketing Experience

Musculoskeletal and connective tissue disorders:

  • Osteonecrosis of the jaw

 

October 2013

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.

 

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