Erwinase for Injection - Special Handling Instructions

Starting date:
February 6, 2017
Posting date:
February 7, 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-62092

Audience

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

Key messages

  • To avoid potential product shortage of ERWINASE, Health Canada has facilitated the temporary importation of UK-labelled product from Batch CAMR-180G 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 180G.
  • Vials of ERWINASE with visible particulate matter must not be administered. Carefully inspect the reconstituted product. If you discover particulate matter after reconstitution, do not administer the product.
  • 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.
  • 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 180G, 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.

To avoid a potential shortage of ERWINASE, Health Canada has not objected to the importation of up to 150 packs of UK-labelled product from the global Batch CAMR-180G as an interim measure.

Products affected

ERWINASE (Erwinia L-asparaginase) Batch CAMR-180G.

BATCH 180G may consist of packaged sub-lots: 180G116, 180G216, 180G316, 180G416, 180G516, 180G117.

Vials from BATCH 180G can be identified by the following label, attached to the carton:

USE 5 MICRON FILTER NEEDLE

SEE NOTICE OF SPECIAL INSTRUCTIONS

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 inspection of BATCH 180G, particulate matter was observed bound to the stopper and/or present on the lyophilized cake of some vials of ERWINASE. The vials that did not pass visual inspection were not released. 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 CAMR-180G, a shortage of ERWINASE is anticipated. It is also anticipated that a new supply of ERWINASE will be delayed until mid-march 2017.

Who is affected

Information for health care professionals

The UK-labelled ERWINASE product is from the 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 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 - 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 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.

Vials of ERWINASE with visible particulate matter must not be administered. Please notify and retain the vial for collection.

Similarly to the Canadian product, the contents of each vial of UK-labelled ERWINASE should be reconstituted in 1 to 2 mL of sodium chloride (0.9%) solution for injection. Slowly add the reconstitution solution against the inner vial wall, do not squirt directly onto or into the powder. Allow the contents to dissolve by gentle mixing or swirling maintaining the vial in an upright position. Avoid froth formation due to excessive or vigorous shaking.

The solution should be clear without any visible particles. Fine crystalline or thread-like wisps of protein aggregates may be visible if shaking is excessive. If there are any visible particles or protein aggregates present, the reconstituted solution should not be used and the vial and content should be discarded.

Even if there is no visible particulate matter after reconstitution, in order to minimise 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.

The solution should be administered within 15 minutes of reconstitution. If a delay of more than 15 minutes between reconstitution and administration is unavoidable, the solution should be withdrawn into a glass or polypropylene syringe for the period of the delay. The solution should be used within 8 hours.

In the event that you discover particulate matter, pre- or post- reconstitution, please notify the Customer Services department and retain the vial for collection.

Action taken by Health Canada

In light of a potential shortage, Health Canada, per the conditions agreed upon by Jazz Pharmaceuticals, has not objected to the importation of UK-labelled ERWINASE BATCH 180G. 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: AEreporting@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
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.