Indications : התוויות

4.1    Therapeutic indications

Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):

-      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;
-      Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.
-      Zygomycosis, in patients intolerant of, or with disease that is refractory to, alternative therapy.

Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.

Noxafil oral suspension is also indicated 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.