THALOMID (thalidomide capsules) - Risk of Second Cancers - For Health Professionals

Starting date:

May 16, 2013

Posting date:

May 22, 2013

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product label update

Audience:

Healthcare Professionals

Identification number:

RA-29245

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

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on THALOMID (thalidomide capsules)

May 16, 2013

Dear RevAid^® Registered Prescriber, RevAid® Registered Pharmacist, or Allied Healthcare Professional:

Celgene Inc., in consultation with Health Canada, would like to inform you of important new safety information which has been added to the Product Monograph for THALOMID^® (thalidomide capsules).

THALOMID^® is an immunomodulatory agent indicated for the treatment of patients who are 65 years of age or older with previously untreated multiple myeloma, in combination with melphalan and prednisone (MPT).

The following points summarize the updated Product Monograph safety information:

• Second primary malignancies, in particular acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), have been observed in an ongoing clinical trial in patients with previously untreated multiple myeloma receiving the combination melphalan, prednisone and THALOMID^® (MPT). AML and MDS have been rarely reported in the post-market setting.
• The risk of AML and MDS must be taken into account before initiating treatment with THALOMID^® in combination with melphalan and prednisone (MPT). Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies.

The THALOMID^® Canadian Product Monograph has been revised to include the updated risk information within the WARNINGS AND PRECAUTIONS and the CONSUMER INFORMATION sections. This information was added as a result of a detailed review of the ongoing MM-020 clinical study, prompted by the observation of an imbalance in hematologic second primary malignancies (AML/MDS). The review of this ongoing study showed a statistically significant increase in the risk of AML/MDS in patients with previously untreated multiple myeloma receiving melphalan, prednisone, and thalidomide (1.8%), compared with patients treated with lenalidomide plus dexamethasone (0.3%) following a median observation time of 22.3 months. The risk with thalidomide increased over time to approximately 2% after 2 years and 4% after three years. The observed cases signal an increased risk of AML/MDS with thalidomide when combined with melphalan, a known leukemogenic agent, in newly diagnosed multiple myeloma patients.

A copy of the most up-to-date THALOMID^®Product Monograph can be found on Health Canada's Web site.

Distribution restrictions: THALOMID^® is only available through a controlled distribution program called RevAid^®. Under this program, only prescribers and pharmacists registered with the program are able to prescribe and dispense the product. In addition, THALOMID^® can only be dispensed to patients who are registered and agree to the requirements of the RevAid^® program. For more information, please log onto RevAid.

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 second primary malignancies or other serious or unexpected adverse reactions in patients receiving THALOMID^® should be reported to Celgene Inc. or Health Canada.

Suspected adverse reactions can be reported to:

Celgene Inc.

6755 Mississauga Road, Suite 600,

Mississauga, ON, L5N 7Y2

Telephone: 1-877-923-5436

Facsimile: 1-289-291-4820

Email: drugsafety-canada@celgene.com

To change your mailing address or fax number, contact Celgene Inc.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

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

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: (613) 954-6522

Fax: (613) 952-7738

Sincerely,

original signed by

Dianne Azzarello, B.Sc.Phm.

Senior Director, Pharmacovigilance & Regulatory Affairs

THALOMID^® and RevAid^® are registered trademarks of Celgene Corporation.