posaconazole (Noxafil)

following an abbreviated submission:

posaconazole tablets (Noxafil®) is accepted for restricted use within NHS Scotland.

Indication under review: 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 in the following patients:
- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.

SMC restriction: to patients in whom there is a specific risk of Aspergillus infection or where fluconazole or itraconazole are not tolerated on the advice of local microbiologists or specialists in infectious diseases.

Posaconazole plasma concentrations are generally higher following administration of posaconazole tablets than posaconazole oral suspension. The tablet and oral suspension are therefore not to be used interchangeably. While the tablets are cost saving when administered for treatment they are significantly more expensive than the oral suspension when administered for prophylaxis.