The Health Products and Food Branch (HPFB) posts on the H ealth Canada w eb site safety alerts,
pu blic health advisories, press releases and other notices as a service to health professionals,
consumers, and other interested parties. These advisories may be prepared with Directorates in the
HPFB which includes pre-market and post-market areas as well as market authorization holders and other
stakeholders. Although the HP FB grants market authorizations or licenses for therapeutic products,
we do not endorse either the product or the company. Anyquestions regarding product information should
be discussed with your health pro fessional.
This is duplicated text of a letter from Schering Canada Inc..
Contact the company for a copy of any references, attachments or enclosures. |
Health Canada Endorsed Important Safety Information on
REMICADE (infliximab) |
November 29th, 2004
Subject: Updated Safety Information addressing the risk of malignancies associated
with REMICADE (infliximab)
Dear Health Care Professional,
Schering Canada, Inc., in consultation with Health Canada, would like to inform you of updated
safety information regarding malignancies. This information will be included in a revised
Canadian Product Monograph for REMICADE (infliximab). Similar information is already
included in the Canadian Product Monographs for other agents in this class of products called
tumor necrosis factor-α blockers or TNF-blockers.
REMICADE (infliximab) is a chimeric IgG monoclonal antibody known as a Biological
Response Modifier that is directed against TNFα. It is indicated for the treatment of
moderately to severely active rheumatoid arthritis and moderately to severely active Crohn’s
disease.
- As with other TNF-blockers, malignancies have been associated with
REMICADE in clinical trials and in post-approval use.
- In clinical trials data, the occurrence of lymphomas was rare. However, patients
treated with REMICADE had a higher incidence of lymphoma than the expected
rate in the general population*.
- Patients with rheumatoid arthritis and Crohn's disease, particularly those with
highly active disease and/or chronic exposure to immunosuppressant
therapies, may be at a higher risk (up to several fold) for the development of
lymphoma than the general population, even in the absence of TNF blocking
therapy. The role of TNF-blockers in the development of malignancy is not
known.
* Refers to general US population
|
Clinical Trials
In the controlled portions of clinical trials of all the TNFα blocking agents, more cases of
lymphoma have been observed among patients receiving a TNF blocker compared with control
patients. During the controlled portions of REMICADE trials in patients with moderately to
severely acute rheumatoid arthritis and Crohn's disease, 1 patient developed lymphoma
among 1389 REMICADE-treated patients versus 0 among 483 control patients (median
duration of follow-up 1.1 years). In the controlled and open-label portions of these clinical trials
of REMICADE, 3 patients developed lymphomas (1 patient with rheumatoid arthritis and 2
patients with Crohn's disease) among 2410 patients (median duration of follow-up 1.1 years).
No studies have been conducted that include patients with a history of malignancy or that
continue treatment in patients who develop malignancy while receiving REMICADE; thus
additional caution should be exercised in considering REMICADE treatment of these patients.
Other than lymphoma, 13 patients developed malignancies, which is similar in number to what
would be expected in the general population. Of these, the most common malignancies were
breast, colorectal, and melanoma.
Post-Approval Use
Malignancies, including non-Hodgkin's lymphoma and Hodgkin's disease, have also been
reported in patients receiving REMICADE during post-approval use worldwide. In Canada, a
total of 14 cases of lymphoma reported to the Canadian Adverse Drug Reaction Monitoring
Program (CADRMP) are temporally associated with REMICADE, based on a cumulative
patient exposure of approximately 27,611 patients.
Cumulatively, approximately 576,000 patients have been treated with REMICADE worldwide.
The Canadian Product Monograph for REMICADE is being revised to include the above updated
safety data.
Reporting rates determined on the basis of spontaneously reported post-marketing adverse
events are generally presumed to underestimate the risks.
The identification, characterization, and management of marketed health product-related
adverse reactions are dependent on the active participation of health care professionals in
adverse drug reaction reporting programmes. Any occurrences of serious and/or unexpected
adverse reactions in patients receiving REMICADE (infliximab) should be reported to Schering
Canada, Inc. or the Marketed Health Products Directorate of Health Canada at the following
addresses:
Schering Canada, Inc.
3535 Trans-Canada Highway
Pointe-Claire, Quebec
H9R 1B4
Toll free Tel : (800) 463-5442 or Toll Free Fax: (800) 369-3090
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed H ealth 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
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information.
The AR Reporting Form
and the AR Guidelines can be found on the Health Canada web site or in The Canadian
Compendium of Pharmaceuticals and Specialties. |
Your professional commitment in this regard has an important role in protecting the well being
of your patients by contributing to early signal detection and informed drug use.
Should you have any questions or require additional information regarding the use of
REMICADE (infliximab), please contact our Medical Services at Schering Canada, Inc. at 800
463-5442.
Sincerely Yours,
original signed by
Patrice Larose, B.Pharm., PhD.
Vice President, Regulatory Affairs, Drug Safety and Medical Services
|
