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Important Safety Information on the Association of Zevalin (ibritumomab tiuxetan) with severe mucocutaneous reactions - Berlex Canada Inc.
- Starting date:
- December 7, 2005
- Posting date:
- December 7, 2005
- Type of communication:
- Public Communication
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Audience:
- General Public
- Identification number:
- RA-19000366
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public 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 HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Berlex Canada Inc.
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Notice about Health Canada advisories
Public Communication
Health Canada Endorsed Important Safety Information on Zevalin® (ibritumomab tiuxetan)
December 7, 2005
Subject: Association of Severe Skin and Mucous Membrane Reactions with the ZEVALIN Treatment Regimen.
Berlex Canada Inc., in collaboration with Health Canada, is informing healthcare professionals of new safety information regarding ZEVALIN. ZEVALIN, as part of the ZEVALIN treatment regimen, is a medication used for the treatment of patients with some types of non-Hodgkin's lymphoma that have received and are not responding to other treatments, including patients with non-Hodgkin's lymphoma that is not responsive to rituximab.
Please be aware of the following important safety information that may be relevant to patients receiving ZEVALIN.
- Severe skin and mucous membrane reactions have been reported since marketing in patients treated with the ZEVALIN treatment regimen, which includes rituximab and ZEVALIN. These reactions consisted of erythema multiforme, a type of allergic skin reaction that sometimes occurs in response to medications, infections or illness, and included Stevens-Johnson syndrome and toxic epidermal necrolysis, more severe forms of this reaction. One case resulted in death.
- Patients who develop a severe skin and mucous membrane reaction should have rituximab and ZEVALIN infusions stopped and should receive medical treatment.
Although the cases of severe skin and mucous membrane reactions associated with the ZEVALIN treatment regimen are rare (0.01% to 0.1%), in one case the patient developed multiple complications, including kidney failure, and died. Skin and mucous membrane reactions have been reported up to four months after treatment with rituximab and ZEVALIN.
Patients noticing a skin or mucous membrane reaction (i.e, a reaction involving moist body surfaces such as those found in the nose, mouth, vagina or anus) during or after ZEVALIN or rituximab treatment should inform their doctor immediately and should not receive any further treatment with rituximab or ZEVALIN. The safety of re-administration of rituximab or ZEVALIN to patients with any skin or mucous membrane reaction has not been determined.
Should you have any question or require further information regarding the use of ZEVALIN, please contact your healthcare provider or Berlex Canada Inc. at 1-800-361-0240.
Berlex Canada Inc.
334 Avro Avenue
Pointe-Claire, Quebec
H9R 5W5
Tel: (800) 361-0240 or Fax: (514) 631-4721
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
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
cadrmp@hc-sc.gc.ca
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.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
Email: mhpd_dpsc@hc-sc.gc.ca
Telephone: (613) 954-6522
Fax: (613) 952-7738