Aprepitant is a NK1 receptor antagonist that is mainly used in the prevention of chemotherapy-induced or postoperative nausea and vomiting. The only licensed medicinal product containing aprepitant that is appropriate for paediatric patients – a powder for oral suspension (Emend 125 mg powder for oral suspension) – is currently unavailable in countries where it is marketed, depriving vulnerable patient groups of a much-needed treatment.
In line with the European Pharmacopoeia Commission’s decision to trial and refine its recently proposed medicine shortage mitigation strategies on two ongoing shortages, the European Drug Shortages Formulary (EDSForm) Working Party has compiled existing knowledge on extemporaneous oral liquid formulations of aprepitant that have been or are being used to alleviate the lack of age-appropriate licensed products. The information and recommendations provided in the resulting first expert opinion are intended to help healthcare professionals in their risk assessment and decision-making processes when faced with the temporary unavailability of Emend 125 mg powder for oral suspension in the setting described above.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and the EDSForm Working Party remind users that, wherever possible, it remains preferable to use a licensed medicine rather than an unlicensed pharmaceutical preparation and that it is the responsibility of the healthcare professionals involved to carry out the risk analysis for each patient.
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