Erwinase for Injection - Shortage and Replacement with UK Labelled Stock
- Starting date:
- August 26, 2016
- Posting date:
- September 16, 2016
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Biologic/vaccine
- Source of recall:
- Health Canada
- Issue:
- Supply
- Audience:
- Healthcare Professionals
- Identification number:
- RA-60014
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 (see July 29, 2016 communication), previously unreleased ERWINASE vials from Batch CAMR-174 with UK labelling are now being made available for use with a 5-micron filter. Small amounts of particulate matter have been observed bound to the stopper of some vials of ERWINASE from Batch CAMR-174.
- 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), discard the vial. If you do not observe particulate matter anywhere, other than on the underside of the stopper, reconstitute the product as usual.
- As an additional precaution, use a standard 5-micron filter needle to withdraw the reconstituted product from the vial prior to administration.
- 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 a routine visual inspection, particulate matter was observed bound to the stopper of some vials of ERWINASE (Batch CAMR-174). 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 not objected to the importation of 40 packs, plus an additional 20 packs as of September 16, 2016, of UK-labelled product from the global Batch CAMR-174 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-174: sub-lot CAMR-174aG116.
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 CAMR-174, particulate matter was observed bound to the stopper of some vials of ERWINASE. The vials that did not pass visual inspection were not released. To reduce the length of the potential product shortage, previously unreleased ERWINASE vials from Batch CAMR-174 are now being made available for use with a 5-micron filter needle. If transferred to the reconstituted ERWINASE, the particulate matter may pose a safety risk to patients.
Transference studies demonstrated that the particulate matter bound to the stopper in the vials from these batches did not transfer to the product during reconstitution.
Without the availability of Batch CAMR-174, a shortage of ERWINASE is anticipated. It is also anticipated that a new supply of ERWINASE will be delayed until late September 2016.
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:
| 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 |
| 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 (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 discarded.
If you do not observe particulate matter anywhere, other than on the underside of the stopper, reconstitute the product as usual.
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 activity1.
In the event that you should need to discard a vial of ERWINASE, 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. 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
Karen Smith
Chief Medical Officer
Jazz Pharmaceuticals
References
1. Health Canada has the data on file, 29 Apr 2016.
Related AWRs
