Archived – Important Safety Information: Use of Kineret (Anakinra) in Combination with Etanercept – Amgen Canada – For the Public

PUBLIC ADVISORY

Important Safety Information Regarding Use of Kineret® (anakinra) in Combination with Etanercept

December 17, 2002 - Amgen Canada Inc., in consultation with Health Canada, advised healthcare professionals of results of a recently completed clinical study conducted in the United States where patients received both Kineret® and etanercept therapy. Kineret® is a medication used to reduce the signs and symptoms of active rheumatoid arthritis.

This study showed that patients receiving both Kineret® and etanercept had a higher incidence of serious infections and experienced no clinical benefit over patients receiving etanercept alone. The results of this study confirmed the rate of serious infections previously reported in a small study where Kineret® was given to patients already being treated with etanercept.

Amgen Canada Inc. has provided information about the recently completed study to healthcare professionals to reinforce the "Warning" already present in the Canadian product monograph for Kineret® regarding use of Kineret® with medicines such as etanercept. Each drug approved for sale in Canada has a product monograph that contains information on the approved use of a medication as well as the possible side effects, precautions, and warnings. This information helps health professionals decide whether or not a particular medication is suitable for an individual patient. The product monograph for Kineret® can be requested from the manufacturer (Amgen) or from your physician or pharmacist.

Patients or their caregivers should immediately report any adverse events while receiving Kineret® to their physicians, and should also consult their physician prior to making any changes in their medication

The new clinical data being conveyed in this letter reflects data obtained during a clinical trial and not data from spontaneously reported adverse events. Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with Kineret® (anakinra).

For more information, please contact Amgen Canada's Medical Information at 1-800-665-4273 extension 360.

Any suspected adverse drug reactions can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

HEALTH CANADA

Address Locator: 0201C2

OTTAWA, Ontario, K1A 1B9

Tel: (613) 957-0337 or Fax: (613) 957-0335

Toll free for consumers and health professionals:

Tel: 866 234-2345, Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The ADR Reporting Form and the ADR Guidelines can be found on the TPD web site or in The Canadian Compendium of Pharmaceuticals and Specialties.