Standard starting dose with options for dose management1

STIVARGA® (regorafenib) dosing in the phase III GRID trial

The recommended starting dose is 160 mg STIVARGA (four 40-mg tablets) taken orally once daily for the first 3 weeks, followed by a 1-week treatment break

One cycle of STIVARGA® (regorafenib) treatment. Once-daily dose of 160 mg (4 tablets) for 3 weeks, followed by dosing-free interval.

Dosing and administration for STIVARGA

  • Treatment should continue until disease progression or until unacceptable toxicity occurs
  • STIVARGA should be taken whole with water after a low-fat meal that contains <600 calories and <30% fat at the same time each day
  • Advise patients to take any missed dose on the same day, as soon as they remember, and that they must not take two doses on the same day to make up for a dose missed on the previous day
  • No dose adjustment is recommended for patients with renal impairment
    • The pharmacokinetics of STIVARGA have not been studied in patients who are on dialysis and there is no recommended dose for this patient population
  • No dose adjustments are required based on mild (total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) >ULN, or total bilirubin >ULN to ≤1.5x ULN) or moderate (total bilirubin >1.5 to ≤3x ULN and any AST) hepatic impairment. Closely monitor patients with hepatic impairment for adverse reactions. STIVARGA is not recommended for use in patients with severe hepatic impairment (total bilirubin >3x ULN), as STIVARGA has not been studied in this population

For your STIVARGA patients:

  • Monitor for AEs within the first week and every 2 weeks thereafter or more often, as needed
  • Reduce dose in 40-mg decrements or discontinue treatment as necessary