Stop marketing of ARSENIC TRIOXIDE MYLAN and re-availability of FOMEPIZOLE APHP

Between September 10 and 12, 2024, the National Agency for the Safety of Medicines and Health Products (ANSM) reported new disruptions or updated the availability data for several specialties marketed in France. [1]distributed exclusively to the hospital.

Stop marketing of ARSENIC TRIOXIDE MYLAN

ARSENIC TRIOXIDE MYLAN is a generic of TRISENOX 1 mg/mL solution for dilution for infusion which has been discontinued since 2020.

As of September 12, 2024, according to the Vidal database and the public drug database, only the ARSENIC TRIOXIDE ACCORD specialty remains marketed.

As a reminder, TRISENOX 1 mg/mL solution for dilution for infusion is indicated for the induction of remission and consolidation in adult patients with:

• Newly diagnosed low- or intermediate-risk acute promyelocytic leukemia (APL) (white blood cell count: ≤ 10 x 103/μL), in combination with all-trans-retinoic acid (ATRA or tretinoin),
• Relapsed/refractory acute promyelocytic leukemia (APL) (prior treatment must have included a retinoid and chemotherapy), characterized by the presence of the t(15;17) translocation and/or the presence of the gene PML/RAR-alpha (promyelocytic leukaemia/retinoic-acid-receptor-alpha).

The response rate of other subtypes of acute myeloid leukemia to arsenic trioxide has not been examined.

Normal availability of FOMEPIZOLE AP-HP

The ANSM has confirmed the normal availability of: