Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Noxafil oral suspension is indicated for use in the treatment of the following fungal infections in adults (see section 5.1):
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:
Non-Interchangeability between Noxafil Tablets and Noxafil Oral Suspension
The tablet and oral suspension are not to be used interchangeably due to the differences between these achieved. Therefore, follow the specific dosage recommendations for each formulation.
Treatment should be initiated by a physician experienced in the management of fungal infections or in the supportive care in the high risk patients for which posaconazole is indicated as prophylaxis.
Noxafil is also available as 100 mg gastro-resistant tablet and 300 mg concentrate for solution for infusion. Noxafil tablets are the preferred formulation to optimize plasma concentrations and generally provide higher plasma drug exposures than Noxafil oral suspension.
Recommended dose is shown in Table 1.
Table 1. Recommended dose according to indication:
| Indication | Dose and duration of therapy (See section 5.2) |
|---|---|
| Refractory invasive fungal infections (IFI)/patients with IFI intolerant to 1st line therapy | 200 mg (5 mL) four times a day. Alternatively, patients who can tolerate food or a nutritional supplement may take 400 mg (10 mL) twice a day during or 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 of 200 mg (5 mL) once a day on the first day, then 100 mg (2.5 mL) once a day for 13 days. Each dose of Noxafil should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure. |
| Prophylaxis of invasive fungal infections | 200 mg (5 mL) three times a day. Each dose of Noxafil should be administered during or immediately after a meal, or a nutritional supplement in patients who cannot tolerate food to enhance the oral absorption and to ensure adequate exposure. The duration of therapy is based on recovery from neutropenia or immunosuppression. For patients with acute myelogenous leukemia or myelodysplastic syndromes, 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. |
An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).
Limited data on the effect of hepatic impairment (including Child-Pugh C classification of chronic liver disease) on the pharmacokinetics of posaconazole demonstrate an increase in plasma exposure compared to subjects with normal hepatic function, but do not suggest that dose adjustment is necessary (see sections 4.4 and 5.2). It is recommended to exercise caution due to the potential for higher plasma exposure.
The safety and efficacy of Noxafil in children aged below 18 years have not been established. Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
For oral use.
The oral suspension must be shaken well before use.
During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses. Accidental overdose was noted in one patient who took posaconazole oral suspension 1,200 mg twice a day for 3 days. No adverse reactions were noted by the investigator.
Posaconazole is not removed by haemodialysis. There is no special treatment available in the case of overdose with posaconazole. Supportive care may be considered.
Unopened container: 3 years.
After first opening the container: 4 weeks.
Do not freeze.
105 mL of oral suspension in a bottle (glass amber type IV) closed with a plastic child-resistant cap (polypropylene) and a measuring spoon (polystyrene) with 2 graduations: 2.5 mL and 5 mL.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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