Archived - Association of Microangiopathic anemia with the combined use of AVASTIN (bevacizumab) and sunitinib malate in metastatic renal cell carcinoma - For the Public

Starting date:

July 11, 2008

Posting date:

July 11, 2008

Type of communication:

Public Communication

Subcategory:

Drugs, Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000641

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

Notice about Health Canada advisories

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

July 11, 2008

Hoffmann-La Roche Limited, in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information concerning the use of AVASTIN^® (bevacizumab) in combination with sunitinib malate.

Subject: The association of a rare type of anemia when AVASTIN^® (bevacizumab) and sunitinib malate are used together to treat patients with kidney cancer that has spread to other parts of the body

AVASTIN is used together with other drugs to treat cancer of the bowel and rectum which has spread to other parts of the body; however it is not approved for use for treatment of kidney cancer or for use together with sunitinib malate. Please note the following new safety information for the use of AVASTIN:

• In a study in the US, AVASTIN (at a dose of 10mg/kg given every 2 weeks) and sunitnib malate (at a dose of 50 mg once a day) was given together to treat kidney cancer that had spread. About one third of those patients were diagnosed with a rare type of anemia.
• Some of these patients experienced side effects that are known and expected for both AVASTIN and sunitinib malate, such as high blood pressure; but in this trial, some of the side effects happened more often with the combination of the two drugs.

Microangiopathic haemolytic anemia (MAHA)

This rare type of anemia occurs when pieces of blood clots get caught in small blood vessels causing partial blockages. Red blood cells (the cells that carry oxygen) traveling through these blood vessels may become damaged.

In studies done in the US, patients with kidney cancer that had spread to other parts of their bodies were treated with both AVASTIN and sunitinib malate. Seven of the 19 patients who received the highest dose of sunitinib malate (50 mg) in combination with a high dose of AVASTIN were diagnosed with MAHA. Four of the 7 patients also had other side effects known to occur with these drugs, such as very high blood pressure. However, within 3 weeks of stopping both drugs, the patients recovered from the MAHA and the other side effects.

The prescribing information for AVASTIN will be revised to include this new safety information.

Some examples of signs and symptoms of MAHA are:

• Abnormally pale skin as well as jaundice (yellowing of skin and eyes)
• Confusion
• Dark colored urine
• Dizziness, weakness or intolerance to physical activity
• Enlarged spleen and liver
• Fever

If you develop any of the above or any other unusual signs or symptoms, please contact your doctor or healthcare professional immediately.

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 anemia or other serious 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, ON 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
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 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 (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738

Sincerely,

original signed by

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