DOSAGE AND ADMINISTRATION
Recommended D ose
The recommended dose of AFINITOR for treatment of advanced renal cell carcinoma is 10 mg, to be taken once daily at the same time every day, either with or without food [see Clinical Pharmacology]. AFINITOR tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.
Continue treatment as long as clinical benefit is observed or until unacceptable toxicity occurs.
Dose M odifications
Management of severe and/or intolerable adverse reactions may require temporary dose reduction and/or interruption of AFINITOR therapy. If dose reduction is required, the suggested dose is 5 mg daily [see Warnings and Precautions].
Hepatic I mpairment: For patients with moderate hepatic impairment (Child-Pugh class B), reduce the dose to 5 mg daily. AFINITOR has not been evaluated in patients with severe hepatic impairment (Child-Pugh class C) and should not be used in this patient population [se e Warnings and Precautions (5.6 ) and Use in Specific Populations].
Strong CYP3A4 I nducers: Avoid the use of concomitant strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital). If patients require co-administration of a strong CYP3A4 inducer, consider increasing the AFINITOR dose from 10 mg daily up to 20 mg daily (based on pharmacokinetic data), using 5 mg increments. 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, the AFINITOR dose should be returned to the dose used prior to initiation of the strong CYP3A4 inducer [see Drug Interactions ] .
DOSAGE FORMS AND STRENGTHS
5 mg tablet
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “5” on one side and “NVR” on the other.
10 mg tablet
White to slightly yellow, elongated tablets with a bevelled edge and no score, engraved with “UHE” on one side and “NVR” on the other.