Gastrointestinal Perforations

• Bevacizumab administration can result in the development of gastrointestinal perforation, in some instances resulting in fatality.
• Gastrointestinal perforation, sometimes associated with intra-abdominal abscess, occurred throughout treatment with bevacizumab (i.e., was not correlated to duration of exposure).
• The incidence of gastrointestinal perforation (gastrointestinal perforation, fistula formation, and/or intra-abdominal abscess) in patients with colorectal cancer and in patients with non-small cell lung cancer (NSCLC) receiving AVASTIN was 2.4% and 0.9%, respectively. The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting.
• Gastrointestinal perforation should be included in the differential diagnosis of patients presenting with abdominal pain on bevacizumab.
• Bevacizumab therapy should be permanently discontinued in patients with gastrointestinal perforation.
• (See WARNINGS: Gastrointestinal Perforations and DOSAGE AND ADMINISTRATION: Dose Modifications.)

Wound Healing Complications

• Bevacizumab administration can result in the development of wound dehiscence, in some instances resulting in fatality.
• Bevacizumab therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention.
• The appropriate interval between termination of bevacizumab and subsequent elective surgery required to avoid the risks of impaired wound healing/wound dehiscence has not been determined.
• (See WARNINGS: Wound Healing Complications and DOSAGE AND ADMINISTRATION: Dose Modifications.)

Hemorrhage

• Fatal pulmonary hemorrhage can occur in patients with non-small cell lung cancer treated with chemotherapy and bevacizumab.
• Incidence: The incidence of serious or fatal hemoptysis was 31% in patients with squamous histology and 2.3% in patients with NSCLS excluding predominant squamous histology.
• Patients with recent hemoptysis (at least one-half teaspoonful of red blood) should not receive bevacizumab.
• (See WARNINGS: Hemorrhage, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION: Dose Modifications.)

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Gastrointestinal perforation should be included in the differential diagnosis of patients presenting with abdominal pain during therapy.
• Labeling revision: Dear Health Professional Letter (January 2005)
• Labeling revision: Dear Health Professional Letter (September 2006)
• Labeling revision: Dear Health Professional Letter (April 2007)
• Labeling revision:(October 2006)

Review Date: April 2007

Package Inserts

Bevacizumab