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Incivek™ (telaprevir) Combination Treatment - Serious Skin Reactions Reported - For the Public

Starting date:
February 27, 2013
Posting date:
February 27, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-23483

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

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

February 27, 2013

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.  Serious skin reactions have been reported in patients taking INCIVEK™ combination treatment and have resulted in treatment in a hospital and death.

INCIVEK™ is a prescription medicine used for the treatment of chronic hepatitis C in adults. The hepatitis C virus infects the liver and is also present in the blood. INCIVEK™ does not work by itself. It is always used in combination with two other drugs: peginterferon alfa and ribavirin.

  • Consult a physician right away if you develop any of the following skin changes during treatment with INCIVEK™ combination treatment: blisters or ulcerations, swelling of your face, rash, with or without itching, mouth sores or ulcers, red or inflamed eyes, like “pink eye” (conjunctivitis), or fever, as they may be a sign of a serious skin reaction.
  • The physician will decide if you need treatment for your rash or if you need to stop taking INCIVEK™, or any of your medicines.
  • INCIVEK™ combination treatment should not be stopped without talking with a physician.

Vertex Pharmaceuticals (Canada) Incorporated has worked with Health Canada to update the safety information for INCIVEK™ and has sent a letter to healthcare professionals to inform them of this new important safety information. A copy of that letter is available on the Health Canada Web site. The newly revised Product Monograph for INCIVEK™ including the updated Consumer Information can be accessed on the Web sites of Health Canada and Vertex Pharmaceuticals (Canada) Incorporated.

Contact your physician if you have any questions regarding your INCIVEK™ combination treatment.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious skin reactions or other serious or unexpected side effects 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

You can report any suspected side effect 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, contact Health Canada at:
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

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.