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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:
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 |
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.
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