Afinitor Dosage/Direction for Use

Afinitor Tablets may be used in all approved indications.
Dosage regimen: Treatment with Afinitor should be initiated by a physician experienced in the use of anticancer therapies.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
General target population: Dosing in hormone receptor-positive advanced breast cancer, advanced neuroendocrine tumors of gastrointestinal, lung or pancreatic origin and advanced renal cell carcinoma: The recommended dose of Afinitor Tablets is 10 mg, to be taken once daily (see Method of administration as follows).
Dose Modifications: Adverse drug reactions: Management of severe or intolerable adverse drug reactions (ADRs) may require temporary dose interruption (with or without dose reduction) or discontinuation of Afinitor therapy. If dose reduction is required, the suggested dose is approximately 50% lower than the daily dose previously administered (see Precautions). For dose reductions below the lowest available tablet strength, alternate day dosing should be considered.
Table 6 summarizes recommendations for dose interruption, reduction, or discontinuation of Afinitor in the management of ADRs. General management recommendations are also provided as applicable. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment. (See Table 6.)

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Moderate CYP3A4/PgP inhibitors: Use caution when administering Afinitor in combination with moderate CYP3A4/PgP inhibitors. If patients require co-administration of a moderate CYP3A4/PgP inhibitor, reduce the Afinitor dose by approximately 50%. Further dose reduction may be required to manage ADRs. For dose reductions below the lowest available strength, alternate day dosing should be considered (see Precautions and Interactions).
If the moderate CYP3A4/PgP inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average for most commonly used moderate inhibitors) before the Afinitor dose is increased. The Afinitor dose should be returned to the dose used prior to initiation of the moderate CYP3A4/PgP inhibitor (see Precautions and Interactions).
Strong CYP3A4 inducers: Avoid the use of concomitant strong CYP3A4 inducers.
If patients require co-administration of a strong CYP3A4 inducer, consider doubling the daily dose of Afinitor (based on pharmacokinetic data), using increments of 5 mg or less. This dose of Afinitor is predicted to adjust the AUC to the range observed without inducers. However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inducers. If the strong inducer is discontinued, consider a washout period of at least 3 to 5 days (reasonable time for significant enzyme de-induction), before the Afinitor dose is returned to the dose used prior to initiation of the strong CYP3A4 inducer (see Precautions and Interactions).
Special populations: Pediatric patients (below 18 years): Afinitor is not recommended for use in pediatric cancer patients and do not use in patients aged <18 years due to a lack of data on safety and efficacy.
Geriatric patients (65 years of age or older): No dosage adjustment is required (see Pharmacology under Actions).
Renal impairment: No dosage adjustment is required (see Pharmacology 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; the dose may be decreased to 2.5 mg if not well tolerated.
Severe hepatic impairment (Child-Pugh C): Not recommended. If the desired benefit outweighs the risk, 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.
Method of administration: Afinitor should be administered orally once daily at the same time every day, either consistently with or consistently without food (see Pharmacology under Actions).
Afinitor Tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.
Missed dose: Afinitor can still be taken up to 6 hours after the time it is normally taken. After more than 6 hours, the dose should be skipped for that day. The next day, Afinitor should be taken at its usual time. Double doses should not be taken to make up for the one that was missed.