Posology : מינונים

4.2   Posology and method of administration

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 two formulations in frequency of dosing, administration with food and plasma drug concentration achieved. Substitution of the tablets for the oral suspension, or vice versa, can result in inadvertent overdosing or underdosing and adverse drug reactions. 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.

Posology
Noxafil is also available as 100 mg gastro-resistant tablet. 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     200 mg (5 mL) four times a day. Alternatively, patients who infections (IFI)/patients with can tolerate food or a nutritional supplement may take 400 mg IFI intolerant to 1st line     (10 mL) twice a day during or immediately following a meal therapy                        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        200 mg (5 mL) three times a day. Each dose of Noxafil should fungal infections              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.
Special populations

Renal impairment
An effect of renal impairment on the pharmacokinetics of posaconazole is not expected and no dose adjustment is recommended (see section 5.2).

Hepatic impairment
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.

Paediatric population
The safety and efficacy of Noxafil in children aged below 18 years have not been established.

Method of administration
For oral use
The oral suspension must be shaken well before use.