Reports of Eye Inflammation, Endophthalmitis, and Toxic Anterior Segment Syndrome (TASS) Following Off-label Intravitreal Use of Avastin (bevacizumab) - For the Public

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Contact: Marketed Health Products Directorate (MHPD)

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

PUBLIC COMMUNICATION
Health Canada Endorsed Important Safety Information on Avastin (bevacizumab)

December 16, 2008

Subject:

Reports of cases of eye inflammation following the unauthorized use of AVASTIN in the eye

Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning the unauthorized use of AVASTIN^® (bevacizumab) when injected into the eye.

AVASTIN is used together with other drugs to treat cancer of the large bowel and rectum which has spread to other parts of the body.

AVASTIN was specifically developed to treat cancer by injection into the veins. AVASTIN was not developed to be injected into the eye. The use of AVASTIN in the eye has not been reviewed or authorized by Health Canada.

Roche has been made aware of a number of cases of eye inflammation following the injection of AVASTIN into the eye. The majority of these cases were seen in patients who were injected AVASTIN Lot B3002B028 into the eye. The quality standards for Lot B3002B028 were reviewed and all tests were well within the limits established for the authorized use of AVASTIN. Other investigations are currently ongoing.

There was no unusual reporting of side effects for people who received this lot for the treatment of cancer in 2008.

The signs and symptoms of this type of reaction in the eye are:

• Eye pain or burning sensation
• Floaters
• Blurred vision
• Eye redness
• Increased eye pressure (found on examination by your doctor)

It is important to see your eye doctor if you have any of these symptoms after an eye injection with AVASTIN. Treatment is important and available for this condition.

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 occurrence of serious and/or unexpected adverse reactions in patients receiving AVASTIN should be reported to Hoffmann-La Roche Limited 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

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Telephone: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Telephone: 866-234-2345
Fax: 866-678-6789
CanadaVigilance@hc-sc.gc.ca

The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel: 613-954-6522
Fax: 613-952-7738

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 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.

Sincerely,

original signed by

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