posaconazole (Noxafil)

following an abbreviated submission

posaconazole concentrate for solution for infusion (Noxafil®) is accepted for use within NHS Scotland.

Indication under review: for use in the treatment of the following fungal infections in adults:

• Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
• Fusariosis in patients with disease that is refractory* to amphotericin B or in patients who are intolerant of amphotericin B;
• Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole;
• Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.

For prophylaxis of invasive fungal infections (IFI) in the following patients:

• Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing IFI;
• Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease (GVHD) and who are at high risk of developing IFI.

Posaconazole 300mg solution for infusion will generally result in higher plasma concentrations than posaconazole oral suspension and is expected to result in similar plasma concentrations as the tablet formulation. Posaconazole solution for infusion is more expensive than oral preparations. It is intended for patients who are not able to receive an oral formulation, and should be used for the minimum time required. Patients should be switched to an oral formulation of posaconazole as soon as clinically practical.