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About NOXAFIL® (posaconazole)

Updated on 15/03/2018

ANTI-FUNGALS

Pozaconazole (NOXAFIL) - the wealth of evidence

Posaconazole (NOXAFIL) is a broad-spectrum triazole antifungal compound indicated for the treatment of fungal infections and the prophylaxis of invasive fungal infections (IFIs).1-3

Posaconazole (NOXAFIL) licensed indications1-3

Prophylaxis
  • Adult patients receiving remission-inducing chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections.
  • Haematopoietic 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.
Treatment
  • Invasive aspergillosis in adult patient with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products.
  • Fusariosis in adult patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B.
  • Chromoblastomycosis and mycetoma in adult patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole.
  • Coccidioidomycosis in adult patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products.
Suspension only2
  • Oropharyngeal candidiasis as first-line therapy in adult 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.

The tablet and oral suspension are not to be used interchangeably due to the differences between these two formulations in frequency of dosing, administration with food and plasma drug concentration achieved. Therefore, follow the specific dosage recommendations for each formulation.

Tablet

Dosing and administration of posaconazole (NOXAFIL) gastro-resistant tablets:

Following a b.d. loading dose on day 1, posaconazole (NOXAFIL) 100 mg tablets offer convenient once-daily dosing starting on day 2 of therapy

Indication Tablets
Prophylaxis of invasive fungal infections Loading dose of 300 mg b.d. on the first day, then 300 mg o.d. thereafter. Each dose may be taken without regard to food intake.

Duration of therapy is based on recovery from neutropenia or immunosuppression. For patients with AML or MDS, prophylaxis with posaconazole (NOXAFIL) should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3
Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy Loading dose of 300 mg b.d. on the first day, then 300 mg o.d. thereafter. Each dose may be taken without regard to food intake.

Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Oropharyngeal candidiasis Not indicated

Oral Suspension

Dosing and administration of posaconazole (NOXAFIL) oral suspension:

Posaconazole (NOXAFIL) 40 mg/ml oral suspension2

Indication Suspension
Prophylaxis of invasive fungal infections 200 mg t.d.s. during/ immediately after a meal, or nutritional supplement in patients who cannot tolerate food to enhance oral absorption.

Duration of therapy is based on recovery from neutropenia or immunosuppression. For patients with AML or MDS, prophylaxis with posaconazole (NOXAFIL) should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3
Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy 200 mg q.d.s.. Alternatively, patients who can tolerate food or a nutritional supplement may take 400 mg b.d. during/ immediately following a meal or nutritional supplement.

Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Oropharyngeal candidiasis Loading dose 200 mg o.d. on the first day, then 100 mg o.d. for 13 days, during/ immediately after a meal, or nutritional supplement in patients who cannot tolerate food to enhance oral absorption.

IV

Dosing and administration of posaconazole (NOXAFIL) IV:

Posaconazole (NOXAFIL) 300 mg IV3

Indication Infusion
Prophylaxis of invasive fungal infections Loading dose of 300 mg b.d. on the first day, then 300 mg o.d. thereafter.

Duration of therapy is based on recovery from neutropenia or immunosuppression.
For patients with AML or MDS, prophylaxis with Noxafil should start several days before the anticipated onset of neutropenia and continue for 7 days after the neutrophil count rises above 500 cells per mm3
Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy Loading dose of 300 mg b.d. on the first day, then 300 mg o.d. thereafter.

Duration of therapy should be based on the severity of the underlying disease, recovery from immunosuppression, and clinical response.
Oropharyngeal candidiasis Not indicated.

Click here    to see posaconazole’s spectrum of activity

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References

  1. NOXAFIL 100 mg Gastro-Resistant Tablets, Summary of Product Characteristics.
  2. NOXAFIL 40 g/ml Oral Suspension, Summary of Product Characteristics.
  3. NOXAFIL 300 mg Concentrate for Solution for Infusion, Summary of Product Characteristics.

Supporting documentation

100 mg Tablets
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

300 mg IV
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

40 mg/ml Oral Suspension
Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

AINF-1247671-0001 | Date of Preparation: March 2018