ARZERRA (ofatumumab) - Fatal Infusion Reaction Reported in a Patient with Chronic Lymphocytic Leukemia - For the Public

Starting date:

August 6, 2014

Posting date:

August 6, 2014

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-40853

This is duplicated text of a letter from GlaxoSmithKline Inc. 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 ARZERRA (ofatumumab)

August 6, 2014

Subject: ARZERRA™ (ofatumumab) – Fatal Infusion Reaction in a patient with Chronic Lymphocytic Leukemia (CLL)

GlaxoSmithKline Inc., in consultation with Health Canada, has informed health care professionals of important new updates to safety information regarding infusion reactions related to ARZERRA™.

ARZERRA™ is a medication that is administered into the veins to treat chronic lymphocytic leukemia (CLL), a type of blood cancer.

• A severe infusion reaction resulting in death was reported in a patient with CLL who was given ARZERRA^TM.
  - Signs and symptoms of an infusion reaction may include the following: swelling of face or mouth, fever,chills, difficulty breathing, tightness of the chest and/or throat, lightheadedness, nausea, diarrhea, and rash.            
  - These symptoms can occur during or shortly after the infusion of ARZERRA^TM. If you experience these or any other symptoms, please notify your health care provider immediately.
• The prescribing information for ARZERRA^TM is being revised to include new information regarding the potential for fatal infusion reactions.
• Patients are reminded that it is important to be closely monitored during and after the infusion by a health care professional, especially if you have a heart condition.

GlaxoSmithKline Inc. has sent a letter to health care professionals informing them of this important safety information. This information may be obtained on the Canadian Web site of GlaxoSmithKline Inc. or on the Health Canada Web site.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious hypersensitivity or infusion reactions or other serious or unexpected side effects in patients receiving ARZERRA™ should be reported to GlaxoSmithKline or Health Canada.

GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Tel: 1-800-387-7374

You can report any suspected side effect associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
   
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

If you have any questions about this new information, please contact GlaxoSmithKline Medical Information Department at 1-800-387-7374.

original signed by

Dr. Sally Taylor
Country Medical Director, Canada
GlaxoSmithKline Inc.

^™ARZERRA is used under license by GlaxoSmithKline Inc.