Erwinase for Injection - Shortage and Replacement with UK Labelled Stock

Starting date:
May 3, 2017
Posting date:
May 3, 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-63180

Audience

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

Key messages

  • To help manage the impact of the ongoing shortage of ERWINASE, Health Canada has facilitated the temporary importation of UK-labelled product from Batch CAMR-181G for use with a 5 micron filter.
  • Small amounts of particulate matter have been observed bound to the stopper and/or present on the lyophilized cake of some vials of ERWINASE from BATCH 181G.
  • If particulate matter is observed elsewhere other than on the underside of the stopper (e.g., on or in the product) before or after reconstitution, do not administer the product and retain for collection.
  • Healthcare professionals are reminded 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 routine inspection of Batch 181G, 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-181G.

Batch 181G may consist of packaged sub-lots: 181G117, 181G217, 181G317, 181G417, 181G517.

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 of Batch 181G, 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.   

Without the availability of Batch 181G, a shortage of ERWINASE is anticipated. It is also anticipated that a new supply of ERWINASE will be available approximately mid-June 2017.

Who is affected

Information for health care professionals

The UK-labelled ERWINASE product is from a global batch and is the same as the Canadian product with respect to composition.

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 Authorization 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 Jazz Pharmaceuticals UK 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 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 Authorization Holder (MAH) 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 Jazz Pharmaceuticals UK 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 anywhere, other than on the underside of the stopper (e.g., on or in the product), before or after reconstitution, should be retained for collection.

Before reconstitution, carefully inspect each vial. If you observe particulate matter anywhere other than on the underside of the stopper (e.g., on or in the product), do not administer the product and retain for collection. If you do not observe particulate matter anywhere, other than on the underside of the stopper, reconstitute the product as usual.

After reconstitution, carefully inspect the reconstituted product. If you discover particulate matter after reconstitution, do not administer the product and retain for collection. If there is no visible particulate matter in the product after reconstitution, as an additional precaution, use a standard 5-micron filter needle to withdraw the reconstituted UK-labelled product from the vial prior to administration. A study has demonstrated that filtration through a 5-micron filter needle after reconstitution has no effect on ERWINASE activity.

Jazz Pharmaceuticals has assessed the overall benefit to risk ratio of administering ERWINASE for the treatment of acute lymphocytic leukemia as positive, particularly with the additional precaution of using a 5-micron filter needle to withdraw the reconstituted product from the vial.

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

In light of a potential shortage, Health Canada, per the conditions agreed upon by Jazz Pharmaceuticals, had not objected to importation of UK-labelled ERWINASE Batch 181G.  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
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


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.