Erwinase for Injection - Shortage

Starting date:
July 7, 2017
Posting date:
July 12, 2017
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-63916

Audience

Healthcare professionals (medical oncologists, haematologists, oncology nurses, pharmacists), chiefs of medicine in hospitals, hospital pharmacy chiefs, cancer clinics.

Key messages

  • Small amounts of particulate matter have been observed bound to the stopper and/or present on the lyophilized cake of some vials of ERWINASE.
  • Vials of ERWINASE with visible particulate matter should not be administered. Follow all the recommended steps for the reconstitution of ERWINASE in accordance with the Canadian Product Monograph.
  • Carefully inspect the reconstituted product. If you discover particulate matter do not administer the product and retain for collection.
  • If there is no visible particulate matter after reconstitution, use a standard 5-micron filter needle to withdraw the reconstituted product from the vial prior to administration as an additional precaution.
  • ERWINASE product that is being distributed in Canada now has Canadian labelling and not UK labelling as mentioned in previous risk communications. The ERWINASE product remains the same, with the same potential safety issue.

 

     

Issue

During routine inspection, particulate matter was observed bound to the stopper and/or present on the lyophilized cake of some vials of ERWINASE. These affected vials were segregated. There is a possibility that some remaining vials may contain particulate matter bound to the stopper and/or on the lyophilized cake, which if transferred to reconstituted ERWINASE, may pose a safety risk to patients.

Products affected

ERWINASE (Erwinia L-asparaginase) Batch CAMR 182 H117

Background information

ERWINASE (Erwinia L-asparaginase) is indicated in the therapy of patients with acute lymphocytic leukemia (ALL) where it is used primarily in combination with other antineoplastic agents to induce remission in children and adults with this disease. It may also be used to treat patients who have developed hypersensitivity (but not anaphylaxis) to L-asparaginase derived from E. coli. ERWINASE should not be used as the sole agent for induction unless combination therapy is considered inappropriate.

During routine inspection, particulate matter was observed bound to the stopper and/or present on the lyophilized cake of some vials of ERWINASE. These affected vials were segregated. There is a possibility that some remaining vials may contain particulate matter bound to the stopper and/or on the lyophilized cake, which if transferred to reconstituted ERWINASE, may pose a safety risk to patients.

The section “Pharmaceutical Information – Reconstituted Solutions” of the Canadian Product Monograph instructs health care providers that “Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use otherwise. […] If the solution should become cloudy, discard.” In the event that you discover particulate matter, pre- or post- reconstitution, please notify the Customer Services department and retain the vial for collection.

Who is affected

Information for healthcare professionals

For complete prescribing information, including Dosage and Administration, please refer to the ERWINASE Canadian Product Monograph (CPM).

ERWINASE should be reconstituted in 1 to 2 mL of sodium chloride (0.9%) solution for injection.  Vials with visible particulate matter anywhere, other than on the underside of the stopper (e.g., on or in the product), before or after reconstitution, should be discarded.

If you do not observe particulate matter anywhere, other than on the underside of the stopper, reconstitute the product as usual.

In order to minimize the potential risk of exposure to sub-visible particulate matter, use a standard 5-micron filter needle to withdraw the reconstituted product from the vial prior to administration as an additional precaution. A study has demonstrated that filtration through a 5-micron filter needle after reconstitution has no effect on ERWINASE activity.1

In the event that you should need to retain a vial of ERWINASE for collection, please contact the Customer Services department for replacement.

Action taken by Health Canada

Health Canada will continue to monitor the situation and work with the sponsor to resolve the issue

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any serious or unexpected side effects in patients receiving ERWINASE should be reported to Jazz Pharmaceuticals or Health Canada.

Jazz Pharmaceuticals
E-mail: DrugSafetyUK@jazzpharma.com
Telephone: 1-800-520-5568 or 1-866-343-0344 (CGF Pharmatech)

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, contact Health Canada at:

Regulatory Operations and Regions Branch
E-mail: dcviu_uvcem@hc-sc.gc.ca
Telephone: 1-800-267-9675
Fax: 1-613-946-5636

Original signed by

Dr Kelvin Tan
Vice President Medical Affairs
Jazz Pharmaceuticals

Reference
1. Health Canada has the data on file, 29 Apr 2016.


For more information

The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.