🇨🇦 Importation of Chinese-Authorized Ifosfamide for Injection due to the Current Shortage of Canadian-Authorized IFEX (Ifosfamide for Injection)

Hazard/Reason: 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 difference

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