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In the treatment of aRCC,

AFINITOR is the only oral once-daily mTOR inhibitor1

Treatment initiation is standard for every patient1

  • 10-mg starting dose is recommended for the majority of patients regardless of age, gender, body weight, or renal function
  • Once-daily dose is taken at the same time every day, consistently with or without food

Dose management guidelines for AFINITOR1

CYP3A4 COADMINISTRATION

  • Increase dose by 5-mg increments up to 20 mg daily if coadministering with strong CYP3A4 inducers. If the strong inducer is discontinued, return the AFINITOR dose to the dose used prior to initiation of the strong CYP3A4 inducer
  • Decrease to 5 mg or 2.5 mg daily if coadministering with a moderate CYP3A4 inhibitor. If the moderate inhibitor is discontinued, return the AFINITOR dose to the dose used prior to initation of the moderate CYP3A4

HEPATIC IMPAIRMENT

  • AFINITOR should not be used in patients with severe hepatic impairment unless the desired benefit outweighs the risk. A dose of 2.5 mg daily must not be exceeded
  • Decrease to 5 mg daily for patients with moderate hepatic impairment
  • Dose adjustments should be made if a patient's hepatic (Child-Pugh) status changes during treatment
    • 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
Abbreviations:
aRCC, advanced renal cell carcinoma; mTOR, mammalian target of rapamycin.
Reference:
  1. AFINITOR [summary of product characteristics]. Novartis Pharma AG; May 2016.