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ERWINASE (Erwinia L-asparaginase) for Injection - Replacement with UK Labelled Stock and Shortage

Starting date:
July 29, 2016
Posting date:
August 2, 2016
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-59654

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 of some vials of ERWINASE from Batch CAMR-177. Vials of ERWINASE with visible particulate matter after reconstitution should be discarded. If there is no visible particulate matter after reconstitution, a standard 5-micron filter needle should be used to withdraw the reconstituted product from the vial prior to administration as an additional precaution.
  • To avoid a potential shortage, Health Canada has facilitated the temporary importation of UK-labelled product from Batch CAMR-177. A standard 5-micron filter needle should be used to withdraw the reconstituted product from the UK-labelled product prior to administration.
  • Healthcare professionals should note that there are some differences between the currently approved Canadian and UK labelling (see Tables 1 and 2). Healthcare professionals should refer to the ERWINASE Canadian Product Monograph for prescribing information.

    

Issue

During a routine visual inspection, particulate matter was observed bound to the stopper of some vials of ERWINASE (Batch CAMR-177). Vials of ERWINASE with visible particulate matter need to be discarded. The global supply of ERWINASE has been affected by this ongoing issue with defective stoppers. To avoid a potential shortage of ERWINASE, Health Canada has facilitated the importation of 50 packs of UK-labelled product from the global Batch CAMR-177 as an interim measure. A standard 5-micron filter needle should be used to withdraw the reconstituted product from the UK-labelled product prior to administration.

Products affected

ERWINASE for Injection (Erwinia L-asparaginase for injection) Batch CAMR-177

Batch 177G may consist of packaged sub-lots: 177G116, 177G216, 177G316, 177G416, and 177G516.

Background information

ERWINASE (Erwinia L-asparaginase) for Injection 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 for Injection should not be used as the sole agent for induction unless combination therapy is considered inappropriate.

During routine visual inspection of Batch CAMR-177, particulate matter was observed bound to the stopper of some vials of ERWINASE. The vials that did not pass visual inspection were segregated and not released.  There is a possibility that some remaining vials may contain particulate matter bound to the stopper which, if transferred to reconstituted ERWINASE, may pose a safety risk to patients.   

Without the availability of Batch CAMR-177, a shortage of ERWINASE is anticipated. It is anticipated that a new supply of ERWINASE will be delayed until approximately late September 2016.

Who is affected

Information for health care professionals

The pharmaceutical composition of the UK-labelled product is the same as the Canadian ERWINASE, but the following differences between the currently approved Canadian and UK labelling should be noted:

Table 1 -ERWINASE VIAL LABEL
Section of the label UK Canada
Name of Product Erwinase® 10,000 Units Lyophilisate for solution for injection
10,000 Units /vial
Erwinase® 10 000 U.
Sterile freeze-dried powder
Crisantaspase (asparaginase from Erwinia chrysanthemi, Erwinia L-asparaginase) Erwinia L-asparaginase
Reconstitution Reconstitute before use. Dissolve in 1 or 2 mL of Sodium chloride Injection, USP.
Marketing Authorisation Holder Porton Biopharma Limited
Porton Down
Salisbury
SP4 0JG
EUSA Pharma SAS
Excipients Sodium Chloride,
Glucose Monohydrate
Not reported on the vial label
Distributor/Local Representative EUSA Pharma (Europe) Ltd CGF Pharmatech Inc.
Montreal Canada
MA number PL44403/002 DIN 02237815
Others No other information on vial label Refer to the enclosed information leaflet
Table 2 - ERWINASE BOX LABEL
Section UK Canada
All English only French Translation
Name of Product Erwinase® 10,000 Units Lyophilisate for solution for injection Erwinase® 10 000 U.
Sterile freeze-dried powder Antileukemic
Crisantaspase (asparaginase from Erwinia chrysanthemi, Erwinia L-asparaginase) Erwinia L-asparaginase for injection
  Each vial contains: 10,000 Units crisantaspase Each vial contains: Erwinia L-asparaginase 10,000 Units
Marketing Authorisation Holder Porton Biopharma Limited
Porton Down
Salisbury
SP4 0JG
EUSA Pharma SAS
Limonest, France, 69760
Excipients Sodium Chloride,
Glucose Monohydrate
Glucose 5.0 mg;
Sodium chloride 0.5 mg
Reconstitution Reconstitute before use. Dissolve in 1 or 2 mL of Sodium chloride Injection USP.
Gently agitate to dissolve. Use only if clear.
Distributor/Local Representative EUSA Pharma (Europe) Ltd CGF Pharmatech Inc. Montreal Quebec, H4T 1A7
MA number PL44403/002 DIN 02237815
Others   Contains no preservative.
For dosage and directions for use see package insert.

For complete prescribing information, including Dosage and Administration, please refer to the ERWINASE Canadian Product Monograph (CPM), which is provided with the UK labelled ERWINASE product, rather than the enclosed UK labelling information.  The UK product will be accompanied by this risk communication and the Canadian Product Monograph.

Similarly to the Canadian product, UK-labelled ERWINASE should be reconstituted in 1 to 2 mL of sodium chloride (0.9%) solution for injection.  Vials with visible particulate matter after reconstitution should be discarded.

Even if there is no visible particulate matter after reconstitution, in order to minimize the potential risk of exposure to sub-visible particulate matter, a standard 5-micron filter needle should be used to withdraw the reconstituted UK-labelled 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 discard a vial of ERWINASE, please contact the Jazz Pharmaceuticals Customer Services department for replacement.

Action taken by Health Canada

In light of a potential shortage, Health Canada facilitated the importation of UK-labelled ERWINASE as an interim measure, per the conditions agreed upon by Jazz Pharmaceuticals. Health Canada will continue to monitor the situation.

Report health or safety concerns

Managing marketed health product-related side effects depends on health care 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
email: DrugSafetyUK@jazzpharma.com
Telephone: 1-800-520-5568

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

Original signed by

Karen Smith
Chief Medical Officer
Jazz Pharmaceuticals

References
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.