Subject: ARZERRA™ (ofatumumab) – Fatal Infusion Reaction in a patient with Chronic Lymphocytic Leukemia (CLL)
MISSISSAUGA, ON, Aug. 6, 2014 /CNW/ - 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.
GSK has sent a letter to health care professionals informing them of this important safety information. This information may be obtained on the Canadian website of GlaxoSmithKline Inc. (www.gsk.ca) or on the Health Canada website.
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.
You can report any suspected side effect associated with the use of health products to Health Canada by:
For other health product inquiries related to this communication, contact Health Canada at:
Original signed by
Dr. Sally Taylor
Country Medical Director, Canada
™ARZERRA is used under license by GlaxoSmithKline Inc.
SOURCE: GlaxoSmithKline Inc.
For further information: If you have any questions about this new information, please contact GlaxoSmithKline Medical Information Department at 1-800-387-7374.