The medicinal product Bleomycine Sanofi 15,000 IU, used in the treatment of certain cancers (testis, throat, mouth, Hodgkin's disease and non-Hodgkin's lymphoma), is currently in limited availability. While waiting for a sufficient quantity of the medicinal product to return to the market, the FAMHP experts recall the recommendations for the rational use of stocks of Bleomycine Sanofi 15,000 IU that may still be available.
The holder of the marketing authorisation for the medicinal product Bleomycine Sanofi 15,000 IU powder for injectable solution, is experiencing production problems. The company expects supply problems at least until March 2022.
The current production capacity is not sufficient to meet all the demands. An allocation per country has been defined. This unavailability is thus not limited to Belgium. Imports from other countries will therefore probably not be possible.
Belgium receives a number of packages of Bleomycine Sanofi 15,000 IU every month. These are allocated only to hospitals for use in oncology.
This unavailability is closely followed up at both national and European level.
While waiting for the availability of the medicinal product Bleomycine Sanofi 15,000 IU, the FAMHP:
• recalls the importance of using Bleomycine for the indications specified by the authorisation file:
- squamous cell carcinoma affecting the mouth, nasopharynx and paranasal sinuses, larynx, oesophagus, external genitalia, cervix or skin,
- Hodgkin's disease and non-Hodgkin's lymphoma,
- testicular carcinoma.
• stresses the importance of rational use of the stocks allocated for indications for which Bleomycine is essential, for example:
- Hodgkin's disease,
- testicular carcinoma,
- to continue the current treatment for each patient (changes in regimens may lead to a decrease in efficacy and/or an increase in toxicity).
For possible alternatives and substitutions, consult the relevant clinical guidelines for the treatment of solid and haemato-oncological tumours. For example in the guidelines of the European Society for Medical Oncology (ESMO).