AIFA, in agreement with the national marketing authorization holder/licensee Bioprojet Italia s.r.l., provides information to healthcare professionals on the upcoming shortage of the medicine Chenpen.

Because of a temporary interruption of production due to a delay in the Technology Transfer at the new manufacturer specialized in filling adrenaline syringes, the medicinal product Chenpen® in all authorized packaging, will be in shortage.

In particular: 

• Chenpen® "150 micrograms/0,3 ml solution for injection" 1x 0,3 ml pre-filled glass syringe (MA n. 040864011) will presumably be in shortage starting from February 2025;
• Chenpen® "300 micrograms/0,3 ml solution for injection" 1x 0,3 ml pre-filled glass syringe (MA n. 040864023) will presumably be in shortage starting from the end of July 2024;
• Chenpen® "500 micrograms/0,3 ml solution for injection" 1x 0,3 ml pre-filled glass syringe (MA n. 040864050) will presumably be in shortage starting from the end of July 2024.

The return of availability of all the 3 strengths of Chenpen® on the European market is expected by the second quarter of 2025.

The supply shortage is not related to any quality defects of the medicinal product or safety issues.
Healthcare Professionals are encouraged to ensure that patients using Chenpen® are informed of this availability issue and, in the event of use or expiration of the autoinjector in their possession, to safely transition patients to an alternative therapy.

For the 150 mcg and 300 mcg dosages, doctors are advised to use alternatives to Chenpen®, marketed in Italy. Switching from one type of medicine to another should only be carried out in consultation with a doctor and requires a close medical supervision in relation to their different use.

The main risk from a safety point of view is represented by dosing errors and treatment interruptions due to the need to learn how to use a new device.

To mitigate the above risks, an accurate training to patients is required until Chenpen® becomes available again on the market.

Published on: 08 July 2024