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
Additional Information
Updated April 2020