Subject: Association of BENLYSTA™ (belimumab) with hypersensitivity and infusion reactions
MISSISSAUGA, ON, May 8, 2012 /CNW/ - GlaxoSmithKline Inc., in consultation with Health Canada, would like to inform you of important new safety information regarding hypersensitivity and infusion reactions, in association with BENLYSTA™ (belimumab) treatment.
BENLYSTA™ is a prescription drug used to treat adults with lupus (systemic lupus erythematosus, also called SLE), who are also receiving other medicines for lupus. At the time of authorization of BENLYSTA™, information and warnings about allergic (hypersensitivity) reactions occurring more often in patients treated with BENLYSTATM (compared to patients not treated with BENLYSTATM) were included in the Product Monograph.
The Product Monograph for BENLYSTA™has been updated with important information for patients, as described below:
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The updated Product Monograph for BENLYSTA™ is available at www.gsk.ca.
GlaxoSmithKline has sent a letter to healthcare professionals informing them of this new safety information. This information may be obtained on the Canadian website of GlaxoSmithKline (http://www.gsk.ca) or on the Health Canada Web site. If you have questions regarding your BENLYSTA™ prescription, please contact your doctor.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious hypersensitivity and infusion reactions, or other serious or unexpected adverse reactions in patients receiving BENLYSTA™ should be reported to GlaxoSmithKline Inc. or Health Canada:
GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Tel: 1-800-387-7374 You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
Postal Locator: 0701E Ottawa, Ontario, K1A 0K9 The Reporting Form, postage paid labels, and Guidelines can be found on the MedEffect TM Canada Web site in the Adverse Reaction Reporting section. http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php For other health products inquiries related to this communication, please contact Health Canada at: Marketed Health Products Directorate e-mail: [email protected] Tel: 613-954-6522 Fax: 613-952-7738 |
Sincerely,
Original signed by
Dr. Glenn Crater, Vice-President, Medical and Chief Medical Officer
™BENLYSTA is a trademark of Human Genome Sciences, Inc., used under license by GlaxoSmithKline Inc. |
For media inquiries please contact GSK Communications at (905) 819-3363.
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