Label Changes for:
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Surgery and Wound Healing Complications
- Necrotizing fasciitis including fatal cases, has been reported in patients treated with Avastin; usually secondary to wound healing complications, gastrointestinal perforation or fistula formation. Discontinue Avastin therapy in patients who develop necrotizing fasciitis
- Necrotizing fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation
WARNINGS AND PRECAUTIONS
- The incidence of ovarian failure was higher (34% vs. 2%) in premenopausal women receiving Avastin in combination with mFolfox chemotherapy as compared to those receiving mFolfox chemotherapy alone for adjuvant treatment for colorectal cancer, a use for which Avastin is not approved. Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin.
- osteonecrosis of the jaw
Clinical Trials Experience
Venous Thromboembolic and Bleeding Events for Patients Receiving Anti-Coagulation
- A randomized, 4-arm study in 1401 patients with mCRC, prospectively evaluating the incidence of VTE (all grades), the overall incidence of first VTE was higher in the Avastin containing arms (13.5%) than the chemotherapy alone arms (9.6%). Among the 116 patients...
- The incidence of new cases of ovarian failure (defined as amenorrhoea lasting 3 or more months, FSH level ≥30 mIU/mL and a negative serum β-HCG pregnancy test)was prospectively evaluated in a subset of 179 women receiving mFOLFOX chemotherapy alone (n= 84 or with Avastin (n=95). New cases of ovarian failure were identified in 34% (32/95) of women receiving Avastin in combination with chemotherapy compared with 2% (2/84) of women receiving chemotherapy alone [relative risk of 14 (95% CI 4, 53)]. After discontinuation of Avastin treatment, recovery of ovarian function at all time points during the post-treatment period was demonstrated in 22% (7/32) of the Avastin-treated women. Recovery of ovarian function is defined as resumption of menses, a positive serum β -HCG pregnancy test, or a FSH level <30 mIU/mL during the post-treatment period. Long term effects of Avastin exposure on fertility are unknown.
USE IN SPECIFIC POPULATIONS
Females of Reproductive Potential
- Avastin increases the risk of ovarian failure and may impair fertility. Inform females of reproductive potential of the risk of ovarian failure prior to starting treatment with Avastin.
- Long term effects of Avastin exposure on fertility are unknown.
- In a prospectively designed substudy of 179 premenopausal women randomized to receive chemotherapy with or without Avastin, the incidence of ovarian failure was higher in the Avastin arm (34%) compared to the control arm (2%). After discontinuation of Avastin and chemotherapy, recovery of ovarian function occurred in 22% (7/32) of these Avastin-treated patients.
PATIENT COUNSELING INFORMATION
- ovarian failure