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

AFINITOR provides flexible dosing for individualized therapy

Dosing adjustments for patients with adverse reactions1

  • Management of severe and/or intolerable suspected adverse reactions may require dose reduction and/or temporary interruption of AFINITOR therapy
  • For adverse reactions of Grade 1, dose adjustment is usually not required. If dose reduction is required, the recommended dose is 5 mg daily and must not be lower than 5 mg daily

Dosing adjustments for patients with hepatic impairment1

  • For patients with mild hepatic impairment (Child-Pugh class A), the dose should be reduced to 7.5 mg daily
  • For patients with moderate hepatic impairment (Child-Pugh class B), the dose should be reduced to 5 mg daily
  • For patients with severe hepatic impairment (Child-Pugh class 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

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.