Afinitor Dosage/Direction for Use

AFINITOR Tablets may be used for all approved indications.
Modify the dosage for patients with hepatic impairment or for patients taking drugs that inhibit or induce P-glycoprotein (P-gp) and CYP3A4 [see as follows].
Recommended Dosage for Hormone Receptor-Positive, HER2-Negative Breast Cancer, Neuroendocrine tumor (NET), Renal Cell Carcinoma (RCC) and Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma: The recommended dose of AFINITOR is 10 mg orally once daily until disease progression or unacceptable toxicity.
Recommended Dosage for Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA): The recommended starting dosage of AFINITOR is 4.5 mg/m² orally once daily until disease progression or unacceptable toxicity [see as follows].
Therapeutic Drug Monitoring (TDM) and Dose Titration for Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA): Monitor everolimus whole blood trough concentrations at time points recommended in Table 7.
Titrate the dose to attain trough concentrations of 5 ng/mL to 15 ng/mL.
Adjust the dose using the following equation: New dose* = current dose x (target concentration divided by current concentration).
*The maximum dose increment at any titration must not exceed 5 mg. Multiple dose titrations may be required to attain the target trough concentration.
When possible, use the same assay and laboratory for TDM throughout treatment. (See Table 7.)

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Dosage Modifications for Adverse Reactions: Table 8 summarizes recommendations for dosage modifications of AFINITOR for the management of adverse reactions. (See Table 8.)

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Dosage Modifications for Hepatic Impairment: The recommended dosages of AFINITOR for patients with hepatic impairment are described in Table 9 [see Precautions]. (See Table 9.)

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Dosage Modifications for P-gp and CYP3A4 Inhibitors: Avoid the concomitant use of P-gp and strong CYP3A4 inhibitors [see Interactions].
Avoid ingesting grapefruit and grapefruit juice.
Reduce the dose for patients taking AFINITOR with a P-gp and moderate CYP3A4 inhibitor as recommended in Table 10 [see Interactions, Pharmacology under Actions]. (See Table 10.)

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Dosage Modifications for P-gp and CYP3A4 Inducers: Avoid concomitant use of St. John's Wort (Hypericum perforatum).
Increase the dose for patients taking AFINITOR with a P-gp and strong CYP3A4 inducer as recommended in Table 11 [see Interactions, Pharmacology under Actions]. (See Table 11.)

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Administration and Preparation: Administer AFINITOR at the same time each day.
Administer AFINITOR consistently either with or without food [see Pharmacology under Actions].
If a dose of AFINITOR is missed, it can be administered up to 6 hours after the time it is normally administered. After more than 6 hours, the dose should be skipped for that day. The next day, AFINITOR should be administered at its usual time. Double doses should not be administered to make up for the dose that was missed.
AFINITOR should be swallowed whole with a glass of water. Do not break or crush tablets.