Monday, January 27, 2014

Health Canada Endorsed Important Safety Information on ARZERRA™ (ofatumumab)

Subject:  ARZERRA™ (ofatumumab) - Recommendations to screen, monitor and to manage hepatitis B virus reactivation
MISSISSAUGA, ON, Jan. 27, 2014 /CNW/ - GSK, in consultation with Health Canada has informed health care professionals of important safety updates regarding the use of ARZERRA™.
ARZERRA™ is a medication that is administered into the veins to treat chronic lymphocytic leukemia (CLL), a type of blood cancer.

  • Use of ARZERRA™ has been shown to be associated with recurrence of Hepatitis B virus infection in patients who show evidence of a previous infection with the Hepatitis B virus, in a blood test. It is advised that all patients be tested for hepatitis B virus infection before starting treatment with ARZERRA™.
  • Infection with hepatitis B virus causes inflammation of the liver which may show as mild fever, feeling of sickness, fatigue, loss of appetite, joint and/or abdominal pain and yellowing of whites of the eyes, skin and tongue.
  • Patients who experience any of these symptoms should immediately contact their healthcare provider.  Patients who show evidence of hepatitis B virus infection may be referred to a liver disease expert for ongoing follow-up and management. Patients with a history of hepatitis should report this to their physician.
  • ARZERRA™ is not to be used in patients with active hepatitis B viral disease. Tell your doctor if you think you have hepatitis B.

The prescribing information for ARZERRA™ has been revised to include new recommendations for the screening, follow-up and management of patients with Hepatitis B reactivation.

GSK has sent a letter to healthcare professionals informing them of this important safety information. This information may be obtained on the Canadian website of GlaxoSmithKline Inc. ( or on the Health Canada website.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious hepatitis B recurrence 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:

For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
Telephone: 1-613-954-6522
Fax:  1-613-952-7738

Original Signed By
Vito S. Racanelli, MD
Dir Medical Affairs,
GlaxoSmithKline Inc.
ARZERRA is used under license by GlaxoSmithKline Inc.
SOURCE GlaxoSmithKline Inc.

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