Data from EMA (European Medicines Agency) - Curated by Marshall Pearce - Last updated 11 July 2017

Indication(s)

- Noxafil 40 mg/mL oral suspension

Noxafil oral suspension is indicated 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;
- 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.

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.

Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.



- Noxafil 100 mg gastro-resistant tablets
- Noxafil 300 mg concentrate for solution for infusion

Noxafil concentrate for solution for infusion is indicated 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.

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 concentrate for solution for infusion 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 (GVHD) and who are at high risk of developing invasive fungal infections.

Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis.

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More information

Category Value
Agency product number EMEA/H/C/000610
Orphan designation No
Date First Approved 25-10-2005
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Merck Sharp & Dohme Ltd.