FDA slaps warning on Avastin due to VTE, bleeding with anticoagulants
The FDA has made changes to the package inset of bevacizumab (Avastin, Genentech) regarding the risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event.
According to the agency, these changes include the following: a new warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and recommendation that females of reproductive potential be informed of the increased risk of ovarian failure prior to starting treatment with bevacizumab; identification of osteonecrosis of the jaw as an adverse reaction of bevacizumab; and new information regarding the risks of venous thromboembolic events and bleeding in patients receiving anticoagulation therapy after first VTE event while receiving bevacizumab.
Specifically for the venous thromboembolic and bleeding events for patients receiving anticoagulation, an information update was added to the clinical trial experience section, venous thromboembolic events: risk of venous thromboembolic events and bleeding in patients receiving anticoagulation therapy after first VTE event while receiving bevacizumab.
The new warning label reads: "A randomized, four-arm study in 1,401 patients with metastatic colorectal cancer, prospectively evaluating the incidence of VTE (all grades), the overall incidence of first VTE was higher in the Avastin containing arms (13.5 percent) than the chemotherapy alone arms (9.6 percent). Among the 116 patients treated with anticoagulants following an initial VTE event (73 in the Avastin plus chemotherapy arms and 43 in the chemotherapy alone arms), the overall incidence of subsequent VTEs was also higher among the Avastin treated patients (31.5 vs. 25.6 percent). In this subgroup of patients treated with anticoagulants, the overall incidence of bleeding, the majority of which were grade 1, was higher in the Avastin treated arms than the chemotherapy arms (27.4 vs. 20.9 percent)."
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interaction and contraindications is available here.
According to the agency, these changes include the following: a new warning subsection describing the increased risk of ovarian failure in premenopausal patients receiving bevacizumab and chemotherapy and recommendation that females of reproductive potential be informed of the increased risk of ovarian failure prior to starting treatment with bevacizumab; identification of osteonecrosis of the jaw as an adverse reaction of bevacizumab; and new information regarding the risks of venous thromboembolic events and bleeding in patients receiving anticoagulation therapy after first VTE event while receiving bevacizumab.
Specifically for the venous thromboembolic and bleeding events for patients receiving anticoagulation, an information update was added to the clinical trial experience section, venous thromboembolic events: risk of venous thromboembolic events and bleeding in patients receiving anticoagulation therapy after first VTE event while receiving bevacizumab.
The new warning label reads: "A randomized, four-arm study in 1,401 patients with metastatic colorectal cancer, prospectively evaluating the incidence of VTE (all grades), the overall incidence of first VTE was higher in the Avastin containing arms (13.5 percent) than the chemotherapy alone arms (9.6 percent). Among the 116 patients treated with anticoagulants following an initial VTE event (73 in the Avastin plus chemotherapy arms and 43 in the chemotherapy alone arms), the overall incidence of subsequent VTEs was also higher among the Avastin treated patients (31.5 vs. 25.6 percent). In this subgroup of patients treated with anticoagulants, the overall incidence of bleeding, the majority of which were grade 1, was higher in the Avastin treated arms than the chemotherapy arms (27.4 vs. 20.9 percent)."
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interaction and contraindications is available here.