Neupogen (filgrastim) and Neulasta (pegfilgrastim) - Risk of Capillary Leak Syndrome - For Health Professionals

Starting date:
April 10, 2014
Posting date:
April 10, 2014
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
Healthcare Professionals
Identification number:
RA-38893

This is duplicated text of a letter from Amgen 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 Neupogen and Neulasta

April 10, 2014

Dear Health Care Professional:

Subject: Neupogen® (filgrastim) is associated with a risk of Capillary Leak Syndrome in patients with cancer and in healthy donors. Neulasta® (pegfilgrastim) is associated with a risk of Capillary Leak Syndrome in patients with cancer.

Amgen Canada Inc., in consultation with Health Canada, would like to inform you of important new safety information concerning the risk of Capillary Leak Syndrome (CLS) associated with the granulocyte colony stimulating factors (G-CSF) NEUPOGEN and NEULASTA.

  • Cases of Capillary Leak Syndrome (CLS) have been reported in:
            a. patients undergoing chemotherapy who were receiving NEUPOGEN or NEULASTA, and
            b. donors undergoing peripheral blood progenitor cell mobilization who were receiving NEUPOGEN.
  • CLS can cause circulatory shock and may be fatal.  It is associated with hypotension, generalized edema, hypoalbuminemia and hemoconcentration.  Episodes can vary in frequency and severity.
  • Should symptoms of CLS be suspected, administration of NEUPOGEN or NEULASTA needs to be stopped and the patient closely monitored.

NEUPOGEN is indicated to:

  • decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs, and for the prevention and treatment of neutropenia, to maintain a normal Absolute Neutrophil Count (ANC) in bone marrow transplant patients and in patients with HIV infection.

NEULASTA is indicated to:

  • decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

Literature and post-marketing cases of Capillary Leak Syndrome (CLS) have been reported uncommonly in patients undergoing chemotherapy and donors undergoing peripheral blood progenitor cell mobilization who were receiving G-CSFs. These have generally occurred in patients with advanced malignant diseases, sepsis, taking multiple chemotherapy medications or undergoing apheresis.

The NEUPOGEN AND NEULASTA Product Monographs are being updated to reflect this new safety information.

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 Capillary Leak Syndrome or other serious or unexpected adverse reactions in patients receiving NEUPOGEN or NEULASTA should be reported to Amgen Canada Inc. or Health Canada.

The revised Product Monographs may be accessed on the Health Canada Web site, or on www.amgen.ca.

Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, Ontario L5N 0A4
Safety Tel: 1-866-512-6436 or Fax: 1-888-264-3655
Safety e-mail: safetycanada@amgen.com

To correct your mailing address or fax number, contact Amgen 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
  • 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.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Sincerely,

original signed by

Clive Ward-Able, MD
Executive Medical Director
AMGEN Canada Inc.