ACTEMRA (tocilizumab) - Risk of Fatal Anaphylaxis - For the Public

Starting date:

September 16, 2010

Posting date:

September 17, 2010

Type of communication:

Public Communication

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000831

This is duplicated text of a letter from Hoffmann-La Roche Limited.
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 ACTEMRA (tocilizumab)

September 16, 2010

Subject: ACTEMRA™ (tocilizumab) and the Risk of Death Due to Severe Allergic Reaction

Hoffmann-La Roche Limited, in consultation with Health Canada, has informed health care professionals of important new safety information regarding ACTEMRA™ (tocilizumab) and severe allergic reactions.

ACTEMRA is a drug that is used intravenously to treat adults with moderate to severe rheumatoid arthritis.

Roche would like to inform you of the following;

• A death from a severe allergic reaction has been reported in a patient with rheumatoid arthritis treated with ACTEMRA. No Canadian cases of anaphylactic reaction have been reported.

• As allergic reactions can occur with the administration of ACTEMRA, it is important that you are monitored closely throughout the infusion for signs and symptoms of any allergic reaction.

• ACTEMRA should not be given to patients who are allergic to tocilizumab or any non-medicinal ingredient in ACTEMRA.

A fatal case of a severe allergic reaction has been reported in an elderly patient with a prolonged history of rheumatoid arthritis who was treated with ACTEMRA. The patient also had prior treatment with other rheumatoid arthritis medication. This patient was also taking rheumatoid arthritis medications while taking ACTEMRA. This patient also suffered from high blood pressure for which the patient was being treated with blood pressure lowering medications.

During the fourth infusion of ACTEMRA, the patient experienced lightheadedness resulting in discontinuation of the infusion. A decrease in blood pressure was noted, and medical attention at the infusion center was followed by an emergency room evaluation. Two weeks later, the patient received a fifth infusion of ACTEMRA after first receiving steroids and antihistamines. Moments after the start of the infusion, the patient experienced dizziness and very low blood pressure. Even though medical attention was delivered promptly, unfortunately, the patient died within 24 hours after these events.

This is the first reported case of a death due to a suspected severe allergic reaction in a patient treated with ACTEMRA. Allergic reactions associated with ACTEMRA and requiring treatment discontinuation have been reported in 13 of 3778 patients receiving tocilizumab in clinical trials. These reactions were generally observed during the second to fifth infusion of ACTEMRA.

In the event of an allergic reaction, ACTEMRA treatment should be stopped immediately. Appropriate medical management should be initiated, and ACTEMRA should be permanently discontinued.

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 reactions, anaphylactic reactions or other serious or unexpected adverse reactions in patients receiving ACTEMRA should be reported to Hoffmann-La Roche Limited, or Health Canada at the following addresses:

Hoffmann-La Roche Limited
Drug Safety Department
2455 Meadowpine Boulevard
Mississauga, Ontario, L5N 6L7
or call toll free at: 1-888-762-4388
or Fax at: 905-542-5864
or email to: mississauga.drug_safety@roche.com

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345
• Complete a Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701E
    Ottawa, Ontario K1A 0K9

The Reporting Forms, postage paid labels, and Guidelines can be found on the MedEffect™ Canada Web site in the Adverse Reaction Reporting section.

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Should you have any questions or require additional information regarding the use of ACTEMRA, please contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time.

Sincerely,

original signed by

Lorenzo Biondi,
Vice President, Medical and Regulatory Affairs
Hoffmann-La Roche Limited