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
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. (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. 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
7333 Mississauga Road
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
Original Signed By
Vito S. Racanelli, MD
Dir Medical Affairs,
™ARZERRA is used under license by GlaxoSmithKline Inc.
SOURCE GlaxoSmithKline Inc.
Labels: ARZERRA™ (ofatumumab), Canada, reactivation, warnings