Adult Dosing
Metastatic colorectal cancer (CRC)
- 160 mg PO once daily x first 21 days of each 28-day cycle
- Note: Administer with a low fat breakfast
Pediatric Dosing
- The safety and efficacy in pediatric patients have not been established
[Outline]
- Therapy may cause severe and fatal hepatotoxicity. Monitor hepatic function prior to and during treatment [FDA Black Box Warning]
- Discontinue therapy in case of hepatotoxicity manifested by elevated liver function tests or hepatocellular necrosis [FDA Black Box Warning]
- Therapy should be discontinued permanently if severe or life-threatening hemorrhage occur
- Interrupt and then reduce or discontinue regorafenib depending on severity and persistence of dermatologic toxicity
- Temporarily or permanently suspend therapy if severe or uncontrolled hypertension occur
- Therapy should be discontinued for new or acute cardiac ischemia/infarction and resumed only after resolution of acute ischemic events
- Discontinue regorafenib if Reversible Posterior Leukoencephalopathy Syndrome (RPLS), Gastrointestinal perforation or fistulae occur
- Do not administer therapy before surgery. Discontinue in patients with wound dehiscence
- Due to the potential of embryofetal toxicity, caution should be exercised in women
- Dermatologic reactions have been reported. interrupt, reduce or discontinue therapy based on severity and/or persistence
Cautions: Use cautiously in
- Hepatic impairment
- Dermatological toxicity
- Hypertension
- Cardiac ischemia and infarction
- Reversible posterior leukoencephalopathy syndrome (RPLS)
- Gastrointestinal perforation or fistulae
- Wound healing complications
- CYP3A4 inducers
- CYP3A4 inhibitors
Pregnancy Category:D
Breastfeeding: Safety unknown. Due to the the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
