Posology : מינונים

4.2    Posology and method of administration

Treatment should be initiated by a physician experienced in the management of fungal infections or in the supportive care of high-risk patients for which posaconazole is indicated as prophylaxis.

Non-interchangeability between Noxafil tablets and Noxafil oral suspension 

The tablet is not to be used interchangeably with the oral suspension 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 dose recommendations for each formulation.

Posology
Noxafil is also available as 40 mg/mL oral suspension. 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         Loading dose of 300 mg (three 100 mg tablets) twice a day on the infections (IFI)/patients with IFI first day, then 300 mg (three 100 mg tablets) once a day thereafter.
intolerant to 1st line therapy     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.


Prophylaxis of invasive fungal      Loading dose of 300 mg (three 100 mg tablets) twice a day on the infections                          first day, then 300 mg (three 100 mg tablets) once a day 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 acute myelogenous leukaemia 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
Noxafil gastro-resistant tablets are not indicated for children and adolescents aged below 18 years.

Method of administration
For oral use
Noxafil gastro-resistant tablets may be taken with or without food (see section 5.2). The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.