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Anti-TNFa Therapy: ENBREL (etanercept), HUMIRA (adalimumab), and REMICADE (infliximab) - Advisories, Warnings and Recalls for the Public

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Contact: Marketed Health Products Directorate (MHPD)

PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on anti-TNFa Therapy: ENBREL (etanercept), HUMIRA (adalimumab), and REMICADE (infliximab)

January 13, 2006

Subject: Possible association between the anti-TNFa products ENBREL (etanercept), HUMIRA (adalimumab), and REMICADE (infliximab) and the relapse of Hepatitis B virus (HBV) infection

The manufacturers of the anti-TNFa products, in collaboration with Health Canada, are informing Canadian healthcare professionals of important new safety information for the anti-TNFa class of products.

These products block tumor necrosis factor-a or TNFa , a key protein in the immune system involved in several autoimmune diseases. The following table lists the anti-TNFa products marketed in Canada, their respective manufacturers, and the condition(s) each is used for:

• Very rare cases of relapse of hepatitis B virus (HBV) infection have been reported in patients receiving the anti-TNFa products Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab).
• Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before beginning therapy with any anti-TNFa product. Those patients identified as carriers of HBV should be monitored for signs and symptoms of relapse of HBV infection throughout their therapy and for several months following termination of therapy.
• Relapse of HBV infection is not unique to the anti-TNFa products and has been reported with other medications that suppress the immune system.

Very rare cases (less than 1 adverse event per 10,000 treated patients) of relapse of HBV infection have been reported in patients receiving anti-TNFa therapy. In the majority of cases, patients were also being treated with other medications that suppress the immune system. Hence, a direct causal relationship between anti-TNFa therapy and relapse of HBV infection may be difficult to establish.

Signs and symptoms of HBV infection include the following:

• yellowing of the skin or eyes (jaundice);
• feeling of sickness;
• tiredness;
• loss of appetite;
• joint pain;
• abdominal pain.

Patients who experience any of these signs and symptoms should contact their doctor immediately. These symptoms may occur several months after starting anti-TNFa therapy.

This advisory is in addition to a letter issued to healthcare professionals discussing the above-mentioned safety information. This letter can be accessed at the Health Canada website at the following address: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/index-eng.php

Following consultation with Health Canada, the Product Monographs for Enbrel, Humira, and Remicade will be revised. If patients have questions regarding their current anti-TNFa treatment, they are asked to contact their doctor or pharmacist.

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 events are generally presumed to underestimate the risks associated with drug treatments. Any cases of serious or unexpected adverse reactions in patients taking Enbrel, Humira, or Remicade should be reported to the manufacturers or Health Canada at the following addresses:

Media enquiries can be directed to the following officials:

ENBREL:
Robert Argiropoulos
Amgen Canada, Inc.
(800) 665-4273 Ext .53444

HUMIRA:
Sylvie Légaré
Abbott Laboratories, Ltd.
(514) 832-7175

REMICADE:
Kent Hovey-Smith
Schering Canada, Inc.
(514) 428-7475

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