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In advanced, progressive, well-differentiated nonfunctional GI and lung NET, and advanced, progressive pNET

AFINITOR is only one tablet, once a day1

 

Simple starting dose1

  • 10-mg starting dose is the same regardless of age, gender, body weight, or renal function
  • Taken once daily, at the same time, consistently with or without food

Afinitor® (everolimus) tablets packaging

Hepatic impairment1

  • 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 recommended only 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

CYP3A4 coadministration1

  • If patients require co-administration of a potent and moderate CYP3A4 inducer, an AFINITOR dose increase from 10 mg daily to 20 mg daily should be considered using 5 mg increments or less applied on Day 4 and 8 following start of the inducer
    • If treatment with the 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 co- administration
  • If patients require coadministration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg daily or 2.5 mg daily may be considered
    • If the moderate inhibitor is discontinued, consider a washout period of at least 2 to 3 days (average elimination time for most commonly used moderate inhibitors) before AFINITOR dose is returned to the dose used prior to initiation of the co-administration

Dosing adjustments for potential drug-drug interactions1

  • Concomitant treatment of AFINITOR and potent CYP3A4 inhibitors is not recommended
  • Use caution when coadministration of moderate CYP3A4 inhibitors or PgP inhibitors cannot be avoided. If patients require coadministration of a moderate CYP3A4 or PgP inhibitor, dose reduction to 5 mg or 2.5 mg daily may be considered
  • Avoid the use of concomitant potent CYP3A4 inducers. If patients require coadministration of a potent CYP3A4 inducer, an AFINITOR dose increase from 10 mg daily to 20 mg daily should be considered using 5-mg increments applied on days 4 and 8 following start of the inducer
Abbreviations:
GI, gastrointestinal; NET, neuroendocrine tumor(s); pNET; pancreatic neuroendocrine tumor(s).
Reference:
  1. AFINITOR [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; May 2016.