Incivek™ (telaprevir) Combination Treatment - Serious Skin Reactions Reported - For Health Professionals

Starting date:

February 22, 2013

Posting date:

February 27, 2013

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-23481

This is duplicated text of a letter from Vertex Pharmaceuticals (Canada) Incorporated. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Health Canada Endorsed Important Safety Information on INCIVEK™ (telaprevir)

February 22, 2013

Dear Healthcare Professional,

Subject:     Serious Skin Reactions Reported with INCIVEK™ (telaprevir) Combination Treatment

Vertex Pharmaceuticals (Canada) Incorporated, in collaboration with Health Canada, would like to inform you of new important safety information regarding serious skin reactions with INCIVEK™ (telaprevir) combination treatment.

INCIVEK™ (telaprevir), in combination with peginterferon alfa and ribavirin, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. Please refer to the INCIVEK™ Product Monograph (PM) for the complete indication.

Serious Warnings and Precautions
Serious Skin Reactions

• Fatal and non-fatal serious skin reactions, including Toxic Epidermal Necrolysis (TEN), Stevens Johnson Syndrome (SJS), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported in patients receiving INCIVEK™ combination treatment. Fatal cases have been reported in patients with progressive rash and systemic symptoms who continued to receive INCIVEK™ combination treatment after a serious skin reaction was identified.
• For serious skin reactions, including rash with systemic symptoms or a progressive severe rash, INCIVEK™, peginterferon alfa and ribavirin must be discontinued immediately. Discontinuing other medications known to be associated with serious skin reactions should also be considered. Patients should be promptly referred for urgent medical care.

A new Serious Warnings and Precautions box for Serious Skin Reactions has been added to the INCIVEK™ PM to reflect this new information. The Warnings and Precautions section has also been updated. The revised PM for INCIVEK™ as well as this letter can be accessed on the Web sites of Health Canada and Vertex Pharmaceuticals (Canada) Incorporated.

Patients should be informed about potential serious skin reactions which may require urgent treatment in a hospital and may result in death. The treating physician will decide if they need treatment or if they need to stop taking INCIVEK™, or any other medication. Please advise your patients not to stop taking INCIVEK™ combination treatment without talking with you first.

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 skin reactions or other serious or unexpected adverse reactions in patients receiving INCIVEK™ combination treatment should be reported to Vertex Pharmaceuticals (Canada) Incorporated or Health Canada.

Vertex Pharmaceuticals (Canada) Incorporated
275 Armand-Frappier Boulevard
Laval, Quebec
H7V 4A7
Calling toll-free at 1-877-634-8789

To correct your mailing address or fax number, contact Vertex.

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:
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Vertex Pharmaceuticals (Canada) Incorporated is committed to patient safety and providing information on the safe and effective use of INCIVEK.

Sincerely,

original signed by

Robert S. Kauffman, MD, PhD
Chief Medical Officer

VERTEX, the VERTEX triangle logo, and INCIVEK, are trademarks of Vertex Pharmaceuticals Incorporated authorized for use in Canada by Vertex Pharmaceuticals (Canada) Incorporated.