Hazard description
There is a critical shortage of Ifosfamide for Injection in Canada. Given the medical necessity of Ifosfamide for Injection and the need to maintain continuity of supply in Canada, Health Canada has authorized the exceptional, temporary importation and sale of Qilu Pharma’s Chinese-authorized Ifosfamide for Injection, 1 g per vial with Chinese-only labels, and supplied with a copy of this Health Product Risk Communication. Healthcare professionals should be aware of important differences between the Chinese-authorized and Canadian-authorized products (see Information for healthcare professionals section). Hospitals should prepare to receive this supply noting the differences between the Chinese and Canadian-authorized products. Stickers or auxiliary labels should be applied to the outer carton and vials to ensure proper identification of the product and access to safe use information (including drug name and storage requirements). AudienceHealthcare professionals at hospitals and units specialized in the use of cytotoxic chemotherapy, Centralized Intravenous Additive Services facilities, wholesalers, and group purchasing organizations Key messagesDue to a critical shortage of IFEX (Ifosfamide for Injection), 1 g and 3 g per vial in Canada, and given the medical necessity of this drug, Health Canada has permitted the exceptional, temporary importation and sale of Chinese-authorized Ifosfamide for Injection, 1 g per vial with Chinese-only labels. This Chinese-authorized product has the same active ingredient (ifosfamide), strength (1 g per vial), dosage form (powder for solution), route of administration (intravenous), and instructions for reconstitution and dilution as the Canadian-authorized product. There are, however, important differences between the Chinese-authorized and the Canadian-authorized products. Healthcare professionals are advised that:There are important differences in storage and stability between Chinese-authorized Ifosfamide for Injection and Canadian-authorized IFEX. For the Chinese-authorized product, there are instructions that should be followed for product storage (store vials at 2°C to 8°C, protected from light) and stability of the reconstituted solution for infusion (see the Information for healthcare professionals section).There are differences in the non-medicinal ingredients between the Chinese-authorized product and the Canadian-authorized product, although they are not expected to be clinically meaningful. The Canadian Product Monograph for IFEX (Ifosfamide for Injection), 1 g per vial by Baxter Corporation (DIN 02241357), available in English and French on Health Canada’s Drug Product Database, should be consulted for information on indications, contraindications, dosage, reconstitution and dilution, special handling instructions, and other safety information.Hospitals are advised to generate a sticker or auxiliary label for the outer carton and vial labels to ensure proper identification of the product and access to safe use information (including drug name and storage requirements). Background Information In Canada, IFEX (Ifosfamide for Injection) is indicated for:Soft Tissue Sarcomafirst-line single agent therapysecond-line single agent therapy in patients who have failed to respond or who have relapsed on other chemotherapeutic regimens.Pancreatic Carcinomasecond-line single agent therapy in patients who have failed to respond or who have relapsed on other chemotherapeutic regimens.Cervical Carcinomaas a single agent or in combination with Cisplatin and Bleomycin in advanced or recurrent disease. Information for healthcare professionalsThe Chinese-authorized product has the same active ingredient (ifosfamide), strength (1 g per vial), dosage form (powder for solution), and route of administration (intravenous) as the Canadian-authorized product. However, the Chinese-authorized product has some important differences from the Canadian-authorized product (Table 1).Table 1: Key differences between Chinese-authorized Ifosfamide for Injection, 1 g per vial and Canadian-authorized IFEX (Ifosfamide for Injection), 1 g per vial Chinese drug product for importationCanadian drug productProduct Brand Name, Strength, Dosage Form, and Route of AdministrationIfosfamide for Injection(Qilu Pharmaceutical (Hainan) Co., Ltd. China)1 g per vialPowder for solution, IntravenousIFEX (Ifosfamide for Injection)(Baxter Corporation, Canada)1 g per vialPowder for solution, IntravenousIdentifying CodeH20093079DIN 02241357Product Presentation Clear glass vial with 20 mm chlorobutyl rubber stopper and 20 mm aluminum seal with magenta color flip-off cap.Clear glass vial with grey bromobutyl rubber stopper and aluminum seal.Non-Medicinal Ingredients Glycine, MannitolNoneStorage and StabilityProduct Vial: Store at 2°C to 8°C.Protect from light, seal, and discard unused portion.Reconstituted Solution:Reconstituted solution is stable for 24 hours at 20°C to 25°C at a concentration of 50 mg/mL in the original container.Reconstituted and diluted solutions are stable for 48 hours in PVC and polypropylene bags at 20°C to 25°C, protected from light.Product Vial:Store at controlled room temperature (20°C to 25°C). Protect from temperatures above 30°C. Discard unused portion.Reconstituted Solution:Reconstituted and further diluted solutions should be used within 24 hours from the time of the initial constitution or within 72 hours when refrigerated when stored in glass bottles, viaflex bag or PAB bags.Images of the Chinese-authorized product can be found in Appendix 1.Healthcare professionals are advised that:The Chinese-authorized product differs significantly from the Canadian-authorized IFEX (Ifosfamide for Injection) product in storage and stability requirements (refer to Table 1 for key differences).The Chinese-authorized product is a single-dose vial, and the unused portion should be discarded after use.The Chinese-authorized product should be stored under refrigeration at 2°C to 8°C, protected from light, and sealed. These storage instructions differ from the Canadian product and are NOT found in the Chinese product labelling or package insert. The storage conditions are supported by stability and compatibility studies.The instructions for reconstitution of the vial (addition of 20 mL of Sterile Water for Injection) and for preparation of the solution for infusion (further dilution in 5% Dextrose, 0.9% Sodium Chloride, or Lactated Ringer’s to achieve concentrations of 0.6 to 20 mg/mL) are the same as the Canadian-authorized product. These instructions are NOT found in the Chinese product labelling or package insert.The Chinese-authorized product is available with labelling in Chinese text only, and is supplied with a copy of this Health Product Risk Communication which includes images of the vial and carton labels translated in English and French.The expression of strength for the Chinese-authorized product displays a trailing zero (i.e., 1.0 g), which increases the potential for 10-fold dosing errors.The Canadian Product Monograph for IFEX (Ifosfamide for Injection), 1 g per vial by Baxter Corporation (DIN 02241357), available in English and French on Health Canada’s Drug Product Database, should be consulted for information on authorized indications, contraindications, dosage, reconstitution and dilution, special handling instructions, and other safety information.Hospitals are advised to generate a sticker or auxiliary label for the outer carton and vial labels to ensure proper identification of the product and access to safe use information (including drug name and storage requirements).The Chinese-authorized product does not have a drug identification number (DIN) or a barcode that scans in medication management systems in Canada. A facility-generated barcode sticker may also be required to enable barcode scanning and allow the product being dispensed and administered to be properly identified.The Chinese-authorized product carton and vials have the Batch Variable Data as Lot Number, Manufacturing Date and Expiry Date. Manufacturing and Expiry are displayed as YYYY.MM.DD. The batch variable data is listed as Batch Number followed by Manufacturing Date and Expiration Date.Proper selection of the intended product must be verified to avoid confusion with other products and to prevent medication errors. Action taken by Health CanadaTo help mitigate the shortage of Ifosfamide for Injection in Canada, Health Canada has permitted the exceptional, temporary importation and sale of Chinese-authorized Ifosfamide for Injection, 1 g per vial, with Chinese-only labels, by SteriMax Inc., and has added this product to the List of Drugs for Exceptional Importation and Sale.Health Canada has worked with SteriMax Inc. to prepare this alert for Chinese-authorized Ifosfamide for Injection. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication will be further distributed through the MedEffect™ e-Notice email notification system. Report health or safety concernsManaging marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Chinese-authorized Ifosfamide for Injection, 1 g per vial should be reported to SteriMax Inc. or to Health Canada.SteriMax Inc., 2770, Portland Drive, Oakville, ON, L6H 6R4Phone: +1-800-881-3550Fax: +1-877-546-7667E-mail: pv@sterimaxinc.com To correct your mailing address or fax number, contact SteriMax Inc.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; orVisiting 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 Enforcement BranchE-mail: hpce-cpsal@hc-sc.gc.ca Telephone: 1-800-267-9675 Questions or concernsFor questions or concerns about Chinese-authorized Ifosfamide for Injection, please contact SteriMax Inc. at medinfo@sterimaxinc.com OR visit SteriMax website. Appendices: Appendix 1 – Carton and Vial image of Chinese-authorized Ifosfamide for Injection, 1 g per vialAppendix 2 – English translation of the Chinese Inner Vial and Outer Carton label Original signed by Ritesh Acharya, M. Pharm.Chief Scientific Officer, SteriMax Inc., Oakville, ON Appendix 1 – Carton and Vial image of Chinese-authorized Ifosfamide for Injection, 1 g per vial:Product descriptionOriginal Product & Vial ImageIfosfamide for Injection, 1 g per vialClear glass vial with 20mm chlorobutyl rubber stopper and 20 mm aluminum seal with magenta colored plastic flip-off cap. Appendix 2 – English translation of the inner vial and outer carton label of Chinese-authorized product:Inner Label (Vial)Original Inner LabelEnglish translation (Mock-up label)Label size is 70mm (L) x 30mm (H).Mock-up label with Batch variable data:Note: 鲁迈® is the trade name in China. Outer Label (Carton)Original Outer LabelEnglish translationCarton dimension: 195mm x 86mm x 38mmNote: 鲁迈® is the trade name in China.
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