Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.
Safety information changes to the package insert for bevacizumab (Avastin, Genentech) were issued by FDA on September 30, 2011. These changes included safety information regarding the risk of ovarian failure, venous thromboembolism (VTE), and bleeding in patients treated with anticoagulants after first VTE episode, and osteonecrosis of the jaw. Bevacizumab is currently indicated for the treatment of metastatic breast, renal cell, or colorectal cancer; non-squamous, non-small cell lung cancer; and glioblastoma.
New to the "Warnings and Precautions" section is a statement that urges women to be informed of the risk of ovarian failure with bevacizumab treatment. This stems from a sub-study of 179 women treated with mFOLFOX chemotherapy regimen plus bevacizumab versus mFOLFOX regimen alone for the treatment of stage 1 or 3 colorectal cancer (off-label use). The relative risk of ovarian failure in women receiving bevacizumab was 14% (95% CI, 4%– 53%) compared to women who did not receive bevacizumab. Ovarian function recovered in 23% of females who experienced failure.
In patients who were treated with bevacizumab for metastatic colorectal cancer, the incidence of first VTE was higher (13.5%) compared to patients without bevacizumab (9.6%). The incidence of a subsequent VTE in those patients who were treated with an anticoagulant was also increased in the bevacizumab group (31.5%) compared to those without bevacizumab treatment (25.6%), as was the incidence of bleeding (27.4% vs 20.9%). This data has been added to the "Clinical Trial Experience" section of the bevacizumab label.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
Are PBMs Putting GLP-1 Drugs on Their Formularies?
October 11th 2024PBMs are putting weight loss drugs, including Wegovy and Zepbound, on their national formularies, but coverage by plans is uneven. What is needed is more data about whether these drugs can lower overall healthcare costs.
Read More