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.
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 Canada.
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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
E-mail: [email protected]
Original Signed By
Vito S. Racanelli, MD
Dir Medical Affairs,
™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.