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DOSING ADJUSTMENTS

AFINITOR provides flexible dosing for individualized therapy1

Dosing adjustments for patients with adverse reactions

  • Management of severe and/or intolerable suspected adverse reactions may require dose alterations, temporary dose interruptions, or permanent discontinuation of AFINITOR therapy
  • If dose reduction is required, the recommended dose is 5 mg daily. If dose reduction is required, the suggested dose is 5 mg daily

Dosing adjustments for patients with hepatic impairment

  • 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 only recommended 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 interactions

  • 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 or less applied on days 4 and 8 following start of the inducer
Abbreviations:
aBC, advanced breast cancer; HR+, hormone receptor-positive; PgP, permeability glycoprotein.
Reference:
1. AFINITOR [summary of product characteristics]. Novartis Pharma AG; 2017.