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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:
| 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 |
| 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
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