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

Starting date:
November 21, 2014
Posting date:
November 21, 2014
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-42607

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

Health Canada Endorsed Important Safety Information on FERAHEME (ferumoxytol)

November 21, 2014

Dear Health Care Professional:

Subject: New important changes to the delivery of FERAHEME® (ferumoxytol) and to restrictions of use to further mitigate risks of serious hypersensitivity 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 on the use of FERAHEME® (ferumoxytol), an intravenous (IV) iron product, authorized in Canada for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).

The Product Monograph (PM) is being revised to reflect the following in an effort to further reduce the risk of serious hypersensitivity reactions due to FERAHEME®:

  • FERAHEME® should only be administered as an intravenous infusion in 50-250 ml of 0.9% sterile sodium chloride or 5% sterile dextrose over a minimum period of 15 minutes following dilution and must no longer be administered by direct injection of the undiluted product.
  • Patients should be closely monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of FERAHEME®.
  • FERAHEME® is contraindicated in patients with any known history of drug allergy.
  • Elderly patients (> 65 years of age) or patients with multiple co-morbidities who experience a serious hypersensitivity reaction due to FERAHEME® may have more severe outcomes. The potential risks and benefits of FERAHEME® administration should be carefully considered in these patients.

In addition, the revised PM will recommend that patients be placed in a reclined or semi-reclined position during infusion and for at least 30 minutes thereafter.

The change of administration from a rapid IV injection to an infusion may reduce the risk of serious hypersensitivity reactions including life-threatening and fatal outcomes reported in the post-market setting, and allow healthcare professionals to better intervene at the first signs of prodromal symptoms of hypersensitivity.

The FERAHEME® dilution should be used immediately. If you have questions on the infusion process, please contact Takeda Canada Inc. 

FERAHEME® is currently contraindicated in patients with any allergies to parenteral iron products or with multiple (two or more) drug allergies. Takeda will now expand this contraindication to include patients with any known history of drug allergy.

In CKD clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1642) of patients receiving FERAHEME®. In non-CKD clinical studies, serious hypersensitivity reactions were reported in 0.6% (6/1014) of patients who received FERAHEME®. In a non-CKD clinical study, moderate to severe hypersensitivity reactions were reported in 2.5% (10/406) of patients treated with FERAHEME® and in 1.0% (2/199) treated with iron sucrose.

FERAHEME® should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

The newly revised PM for FERAHEME® (ferumoxytol) will be available on the Web sites of Health Canada and Takeda Canada Inc.

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 or other serious or unexpected adverse reactions 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

To correct your mailing address or fax number, contact Takeda Canada 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

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.

For more information

The update to the product monograph was not a result of a Health Canada safety review. Therefore a Summary Safety Review is not available.