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Bevacizumab (removed 6/20/2019)

GI Perforation; Wound Healing Complications (removed 6/20/2019)

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.

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.

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.

Pediatric Use

  • The safety and effectiveness of Avastin in pediatric patients have not been established. In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years who have received Avastin. Avastin is not approved for use in patients under the age of 18 years.
  • Antitumor activity was not observed among eight pediatric patients with relapsed glioblastoma who received bevacizumab and irinotecan. Addition of Avastin to standard of care did not result in improved event-free survival in pediatric patients enrolled in two randomized clinical trials, one in high grade glioma (n= 121) and one in metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma (n= 154).
  • Based on the population pharmacokinetics analysis of data from 152 pediatric patients with cancer (7 months to 21 years of age), bevacizumab clearance normalized by body weight in pediatrics was comparable to that in adults.

Embryo-Fetal Toxicity

  • Based on its mechanism of action and findings from animal studies, Avastin may cause fetal harm when administered to pregnant women. Congenital malformations were observed with the administration of bevacizumab to pregnant rabbits during organogenesis every 3 days at a dose as low as a clinical dose of 10 mg/kg. Furthermore, animal models link angiogenesis and VEGF and VEGFR2 to critical aspects of female reproduction, embryo-fetal development, and postnatal development. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose.

FDA and Industry Communications

Index to FDA Drug Safety Information

Patient Counseling Information

Package Inserts

Bevacizumab

Additional Information

Updated November 2022