"Production problems that have occurred in recent months have temporarily led to a critical situation in the global supply" of Insuman rapid (human insulin) 100 IU/ml solution for injection, both in the cartridge formulation (deficient since 23 January) and in the pen (since 31 January).
"The expected date for the return to normal supply is December 2023" and in this period "replacement with alternative formulations" will be necessary because "interruption of treatment is potentially life-threatening".
This was announced by Sanofi, in agreement with the European Medicines Agency (Ema) and the Italian Medicines Agency (Aifa), in a note published on the Aifa portal.
Insuman (insulin human) is an insulin analogue, identical to the insulin made in the body, produced by a method known as "recombinant DNA technology", indicated for the treatment of diabetes mellitus when insulin treatment is required and can It can also be used to treat coma caused by high blood sugar and ketoacidosis (high levels of ketones in the blood).
The unavailability of the product, it says, "increases the risk of hyperglycemia and potentially diabetic ketoacidosis".
Therefore "no new patient will have to start therapy with Insuman Rapid and patients already on treatment will have to switch to an alternative medicine".
Risk minimization recommendations
If other preparations of recombinant human insulin are not available, "it may be necessary to switch to an insulin analogue".
As for the causes, "several events that occurred in a production site in recent months have caused a temporary shortage of Insuman Rapid; among these are the delay in the supply of disposable pen components, technical problems in the filling, assembly and of packaging".