Noxafil- Liquid agent for Candida, Aspergillus

Product:

Noxafil

Company:

Schering

Pharmacologic class:

Antifungal (triazole)

Active ingredient:

Posaconazole 40 mg/mL; oral suspension; cherry flavor.

Indication:

Prophylaxis against invasive Aspergillus and Candida infections, in patients at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with Graft vs. Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia due to chemotherapy.

Pharmacology:

Posaconazole is an antifungal agent which works by inhibiting the production of ergosterol, a component of fungal cell membranes. It has shown in vitro activity against Aspergillus fumigatus and Candida albicans.

Clinical trials:

A study was conducted with hematopoietic stem cell transplant recipients with GVHD in which posaconazole was compared to fluconazole for 16 weeks. Efficacy of prophylaxis against invasive fungal infections (IFIs) was assessed using a composite end point of proven/probable IFI, death, or treatment with systemic antifungal therapy. Patients were assessed while on study therapy plus seven days and at 16 weeks post-randomization. The mean duration of therapy was 80 days for posaconazole and 77 days for fluconazole. At 16 weeks, the clinical failure rate for posaconazole was similar to that of fluconazole; all-cause mortality was similar for the two groups as well.

In a second study, treatment with posaconazole was compared with fluconazole or itraconazole as IFI prophylaxis in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukemia. The mean duration of therapy was 29 days for posaconazole and 25 days for fluconazole or itraconazole. The clinical failure rate for patients treated with posaconazole was lower than that for patients given fluconazole or itraconazole (27% vs. 42%). At 100 days, all-cause mortality was lower in the posaconazole group than in the fluconazole/itraconazole group (14% vs. 21%).

Adults:

Take with food (full meal or liquid nutritional supplement). ≥13 years: 200 mg three times daily.

Children:

<13 years: not recommended. Contraindications: Concomitant ergots. Drugs that cause QT prolongation and are metabolized by CYP3A4 (e.g., quinidine, halofantrine, pimozide, cisapride, astemizole, terfenadine).

Precautions:

Correct potassium, calcium, magnesium levels before starting. Monitor liver function tests before starting and during therapy. Proarrhythmic conditions. Patients who cannot eat a full meal or nutritional supplement or those with severe renal impairment, severe diarrhea, or vomiting: monitor for breakthrough fungal infections. Pregnancy (Cat. C). Nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid drugs that lower posaconazole levels (e.g., cimetidine, rifabutin, phenytoin).

Potentiates cyclosporine, tacrolimus (monitor); midazolam, vinca alkaloids: reduce doses of these. May potentiate statins; sirolimus, calcium channel blockers (monitor).

Adverse reactions:

Fever, headache, GI upset, anorexia, abdominal pain, fatigue; lab abnormalities (e.g., neutropenia, bilirubinemia, increased liver enzymes), rash, somnolence.

How supplied:

Suspension—105 mL.

For more information call Schering at 800.526.4099.

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