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Avastin (bevacizumab) - Association with Allergic Reactions - For Health Professionals

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Hoffmann-La Roche Limited.
Contact the company for a copy of any references, attachments or enclosures.

Health Canada Endorsed Important Safety Information on AVASTIN (bevacizumab)

August 19, 2010

Dear Health Care Professional,

Subject: Association of AVASTIN^® (bevacizumab) with Hypersensitivity Reactions and Infusion Reactions

Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, would like to inform you of an important update to the safety information regarding the use of AVASTIN. Hypersensitivity reactions and infusion reactions have been identified as risks in patients treated with AVASTIN.

AVASTIN is a recombinant humanized monoclonal antibody that is directed against the vascular endothelial growth factor (VEGF). It is authorized for intravenous administration in the following:

• first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with fluoropyrimidine-based chemotherapy;
• treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in combination with carboplatin/paclitaxel chemotherapy regimen;
• treatment of patients with metastatic HER2-negative breast cancer who are ECOG Class 0-1 in combination with paclitaxel*;
• treatment of patients with glioblastoma after relapse or disease progression, following prior therapy*.

*It should be noted that the breast cancer and glioblastoma indications have been issued a marketing authorization with conditions, pending the results of confirmatory studies to verify clinical benefit. A marketing authorization with conditions is issued to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada.

In clinical trials, anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving AVASTIN in combination with chemotherapy than with chemotherapy alone. The incidence of these reactions in clinical trials of AVASTIN is common (up to 5% in AVASTIN-treated patients). No fatal cases with a clear causal association with AVASTIN treatment have been reported so far from clinical trials.

AVASTIN has been administered to more than 500,000 cancer patients. Although, for the overall population, the incidence of hypersensitivity was very similar between the AVASTIN and comparator groups, imbalances were noted in hypersensitivity reactions and infusion reactions reported in some clinical studies among patients treated with AVASTIN and chemotherapy. Medical assessment of all reports from the Roche safety database showed that the majority of cases were confounded by concomitant chemotherapy. Seven cases of positive rechallenge and two cases with a positive cutaneous test were identified. In light of this information, Roche considers there is sufficient evidence to confirm the causal role of AVASTIN in the occurrence of hypersensitivity reactions and infusion reactions.

Patients should be closely monitored during and after AVASTIN infusion as expected for any infusion of a therapeutic humanized monoclonal antibody. If a reaction occurs, the infusion should be interrupted and appropriate medical therapies administered. A systematic premedication specifically for AVASTIN administration, in general, is not warranted; however, use of premedication should be based on clinical judgment.

The Canadian Product Monograph (CPM) for AVASTIN has been revised to include this updated safety information.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious hypersensitivity reactions, infusion reactions, or other serious or unexpected adverse reactions in patients receiving AVASTIN should be reported to Roche or Health Canada at the following addresses:

Should you have any questions or require additional information regarding the use of AVASTIN, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388, Monday to Friday, between 8:30 a.m. and 4:30 p.m. (Eastern Standard Time).

Sincerely,

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited