Afinitor Dosage/Direction for Use

Treatment with Afinitor should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Posology: For the different dose regimens Afinitor is available as 2.5 mg, 5 mg and 10 mg tablets.
The recommended dose is 10 mg everolimus once daily. Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
If a dose is missed, the patient should not take an additional dose, but take the next prescribed dose as usual.
Dose adjustment due to adverse reactions: Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of Afinitor therapy. For adverse reactions of Grade 1, dose adjustment is usually not required. If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily.
Table 5 summarises the dose adjustment recommendations for specific adverse reactions (see also Precautions). (See Table 5.)

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Special populations: Elderly patients (≥65 years): No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Mild hepatic impairment (Child-Pugh A) - the recommended dose is 7.5 mg daily.
Moderate hepatic impairment (Child-Pugh B) - the recommended dose is 5 mg daily.
Severe hepatic impairment (Child-Pugh C) - Afinitor is only recommended if the desired benefit outweighs the risk. In this case, a dose of 2.5 mg daily must not be exceeded.
Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment (see also Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of Afinitor in children aged 0 to 18 years have not been established. No data are available.
Method of administration: Afinitor should be administered orally once daily at the same time every day, consistently either with or without food (see Pharmacology: Pharmacokinetics under Actions). Afinitor tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.