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Health professional risk communication

FERAHEME (ferumoxytol) - Important Changes to the Delivery and New Restrictions on the Use Due to Information on Serious Allergic Reactions - For the Public

Starting date:
November 21, 2014
Posting date:
November 21, 2014
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-42609

This is duplicated text of a letter from Takeda Canada 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 FERAHEME (ferumoxytol)

November 21, 2014

Subject: New important changes to the delivery of FERAHEME® (ferumoxytol) and to restrictions of use due to additional information on serious allergic reactions

Further to Takeda Canada’s recent communication of July 11, 2014, in collaboration with Health Canada, Takeda would like to inform you of the following important new changes and restrictions on the use of FERAHEME® (ferumoxytol) due to additional information on serious allergic reactions.

FERAHEME® (ferumoxytol) is an iron product that is given by injection into a vein. It is authorized in Canada for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD).

  • FERAHEME® should only be given by intravenous infusion of the diluted product over a minimum period of 15 minutes. It should no longer be given by direct injection of the undiluted product into a vein.
  • FERAHEME® should no longer be used in patients with any known history of drug allergy.
  • Patients should be closely monitored for signs and symptoms of allergic reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of FERAHEME®.
  • Patients should speak to their doctor before receiving FERAHEME® if they are older than 65 years or have an underlying condition, such as liver or heart disease, as the risk of having severe consequences including death may be higher after a serious allergic reaction.

In addition, patients should be in a reclined or semi-reclined position while receiving the infusion and for at least 30 minutes thereafter.

The change from a rapid injection to an infusion may reduce the risk of serious allergic reactions and allow the healthcare professional to help the patient early when experiencing such a reaction.

Patients should also be aware that they should only receive FERAHEME® in a setting where appropriate personnel and therapies for the treatment of serious allergic reactions are also immediately available.

Takeda Canada Inc. is working with Health Canada to update the safety information for FERAHEME® and has sent a letter to health care professionals to inform them.  A copy of that letter is available on the Health Canada Web site.

The newly revised Product Monograph for FERAHEME® (ferumoxytol), which includes the above-mentioned information, will be available on the Web sites of Health Canada and Takeda Canada Inc.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious allergic reactions or other serious or unexpected side effects in patients receiving FERAHEME® should be reported to Takeda Canada Inc. or Health Canada.

Takeda Canada Inc.
435 North Service Road West, 1st Floor
Oakville, ON  L6M 4X8
Telephone: 1-866-295-4636

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:
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. Brad Pamenter
Vice President, Medical and Scientific Affairs
Takeda Canada Inc.

FERAHEME® is a registered trademark of AMAG Pharmaceuticals, Inc. and used under license by Takeda Canada Inc.