Due to supply issues, Azactam 1 g and Azactam 2 g powder for solution for injection/infusion are currently only available in very limited quantities on the Belgian market. The available stock is not sufficient to meet patients’ needs during the expected period of shortage. Production is not expected to resume before July 2027. The FAMHP's task force on Unavailability issues recommendations.
As a result of issues related to compliance with good manufacturing practice standards at the contract manufacturer, the marketing authorisation holder, Laboratoires Delbert S.A.S., is currently experiencing availability issues with regard to Azactam. The quantities available are insufficient to meet total demand in Belgium.
Recommendations for (hospital) pharmacists and specialist doctors
In order to reserve the remaining stock for patients with the greatest medical need, the use of Azactam 1 g and Azactam 2 g is
- restricted to hospitals;
- reserved exclusively for the following indication. Treatment of multi-resistant Gram-negative infections, including infections caused by organisms that produce metallo-beta-lactamases (MBLs) (e.g. NDM, VIM, IMP), when necessary in combination with ceftazidime/avibactam (Zavicefta 2 g / 0.5 g powder for concentrate for solution for infusion). The start date, dosage and duration of treatment must be discussed with an infectious diseases specialist or a medical microbiologist and monitored closely.
For all other indications for Azactam, suitable alternatives are generally available. The choice depends on the type of infection, resistance and causative organism. Potential alternatives should be selected on the basis of susceptibility testing, principles of antimicrobial stewardship and, where applicable, specialist advice.
Controlled distribution and declaration on honour
During the period of unavailability, orders for Azactam 1 g and Azactam 2 g are reserved exclusively for hospitals and are subject to controlled distribution. Orders may only be placed for patients who meet the priority indication as described in these recommendations and must be accompanied by a declaration on honour from the hospital. The practical arrangements for this controlled distribution will be communicated separately to hospital pharmacies.
Monitoring by the FAMHP
The task force is making a strong appeal to the sense of responsibility of all healthcare professionals to help tackle this extremely critical situation. The FAMHP is closely and continuously monitoring the availability of Azactam 1 g and 2 g and continues to work closely with the task force on Unavailability, the Minister’s policy cell, the marketing authorisation holder and the European Medicines Agency (EMA).
Excerpt from the official page. The original is authoritative.