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ZIV-Aflibercept (BBRx deleted 3/11/2020)

3/11/2020 ENTIRE BOX WARNING DELETED

Hemorrhage; Gastrointestinal Perforation; Comproised Wound Healing

Hemorrhage

  • Severe and sometimes fatal hemorrhage, including gastrointestinal (GI) hemorrhage, has been reported in the patients who have received Zaltrap in combination with FOLFIRI.
  • Monitor patients for signs and symptoms of GI bleeding and other severe bleeding. Do not administer Zaltrap to patients with severe hemorrhage.

Gastrointestinal Perforation

  • Gastrointestinal perforation including fatal GI perforation can occur in patients receiving Zaltrap. Discontinue Zaltrap therapy in patients who experience GI perforation.

Compromised Wound Healing

  • Severe compromised wound healing can occur in patients receiving Zaltarp/Folfiri.  Discontinue Zaltrap in patients with compromised wound healing.
  • Suspend Zaltrap for at least 4 weeks prior to elective surgery, and do not resume therapy for at least 4 weeks following major surgery and until the surgical wound is fully healed.

Patient Counseling Information

Package Inserts

Ziv-aflibercept

Additional Information

Updated April 2020