BENLYSTA (belimumab) – Association with Hypersensitivity and Infusion Reactions – For the Public

Starting date:

May 8, 2012

Posting date:

May 8, 2012

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-190001051

This is duplicated text of a letter from GlaxoSmithKline Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication – Health Canada Endorsed Important Safety Information on BENLYSTA (belimumab)

May 8, 2012

Subject: Association of BENLYSTA™ (belimumab) with hypersensitivity and infusion reactions

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 BENLYSTA™ (compared to patients not treated with BENLYSTA™) were included in the Product Monograph.

The Product Monograph for BENLYSTA™has been updated with important information for patients, as described below:

• BENLYSTA™ can cause a reaction to the infusion or an allergic (hypersensitivity) reaction. These can affect 1 to 10 users in 100, and can occasionally be severe, and can cause death. They are more likely to happen on the day of treatment, but can happen later.




• BEFORE you receive BENLYSTA™, tell your healthcare provider if you have had an allergic reaction to other drugs or shots/injections. You may be given medicines to help prevent reactions before you are given BENLYSTA™.




• Contact your doctor immediately if you develop any of the following symptoms after being treated with BENLYSTA™:
  • swelling of face, mouth, lips or tongue, causing difficulty in breathing
  • rash, possibly with itchy raised bumps or hives
  • light-headedness when you stand up (possibly due to low blood pressure)
  • slow heart beat
  • shortness of breath

The updated Product Monograph for BENLYSTA™ is available on the Canadian website of GlaxoSmithKline.

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 or on the Healthy Canadians Web site. If you have questions regarding your BENLYSTA™ prescription, please contact your doctor.

For media inquiries please contact GSK Communications at 905-819-3363.

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

Telephone: 1-800-387-7374

To report suspected adverse reactions to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or visit the MedEffect™ Canada Web site for information on how to report.

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section. The Reporting Form is also in the Canadian Compendium of Pharmaceuticals and Specialties.

For other health product inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

e-mail: mhpd_dpsc.public@hc-sc.gc.ca

Telephone: 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.