Mitomycine Substipharm 20 mg Filter Update for Injection Administration

ANSM updated its 2021 safety guidance on Mitomycine Substipharm 20 mg filtering requirements. The Millex HV filter (0.45 μm / PVDF) is now permanently included with the product. Filtering requirements vary by route: filtration is required for IV, intra-arterial, and intra-serous administration; it is explicitly no longer required for intravesical administration. The agency states filtering does not alter mitomycin C concentration or efficacy.

Hospital pharmacists, urologists, oncologists, and clinical staff should immediately review and update their preparation and administration protocols for Mitomycine Substipharm 20 mg. Ensure staff are trained on the new filtering requirements specific to each administration route. Only the Millex HV filter should be used; alternative filters are not recommended.