Note: "authorized" which does not include a notation for those patients in clinical trials/ovarian cancer
August 2010
*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.
- A risk of developing serious hypersensitivity reactions,
including anaphylactic and anaphylactoid reactions, has been reported
in up to 5% of patients receiving AVASTIN in clinical trials.
Post-marketing reports have also captured cases of serious
hypersensitivity and infusion reactions.
- Infusion and hypersensitivity reactions may manifest as:
dyspnea/difficulty breathing, flushing/redness/rash, hypotension or
hypertension, oxygen desaturation, chest pain, rigors, and
nausea/vomiting.
- Patients should be closely monitored for signs and
symptoms of hypersensitivity or infusion reactions during and following
the administration of AVASTIN infusion.
- If a reaction occurs, the infusion should be interrupted and appropriate medical therapies should be administered.
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:
Hoffmann-La Roche Limited
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or fax at: 905-542-5864
or email to:
mississauga.drug_safety@roche.com
You can report any suspected adverse reactions associated with
the use of health products to the Canada Vigilance Program by one of
the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the
Adverse Reaction Reporting section. The Reporting Form is also in the
Canadian Compendium of Pharmaceuticals and Specialties.
For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail:
mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738
To change your mailing address or fax number, contact the Market Authorization Holder (Industry).
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
Risk prediction 
