Bayer HealthCare Pharma


Concise Prescribing Info
Regorafenib (as monohydrate)
Patients w/ metastatic colorectal cancer who have been previously treated w/, or are not considered candidates for fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and, if RAS wild type, an anti-EGFR therapy. Patients w/ GI stromal tumors who have been previously treated w/ 2 tyrosine kinase inhibitors. Patients w/ hepatocellular carcinoma (HCC) who have been previously treated w/ sorafenib.
Dosage/Direction for Use
160 mg (4 tab) once daily for 3 wk on therapy, followed by 1 wk off therapy to comprise a cycle of 4 wk. Dose modification: Apply in 40 mg steps. Min recommended daily dose: 80 mg. Max daily dose: 160 mg.
Should be taken with food: Take at the same time each day w/ a low-fat meal (<30% fat).
Special Precautions
Severe hepatic impairment. Perform liver function tests (ALT, AST & bilirubin) prior to initiation of treatment & closely monitor every 2 wk during the first 2 mth of treatment; periodically monitor mthly; mild indirect hyperbilirubinemia may occur in patients w/ Gilbert's syndrome. May increase incidence of infection & hemorrhagic events, MI & myocardial ischemia, arterial HTN, & electrolyte & metabolic abnormalities. Monitor blood counts & coagulation parameters in patients w/ conditions predisposing to bleeding & in those treated w/ anticoagulants (eg, warfarin) & drugs that increase risk of bleeding; control of BP prior to initiation of therapy; biochemical & metabolic parameters during treatment. History of ischemic heart disease. Discontinue treatment if severe bleeding, GI perforation or fistula, severe HTN develops; reversible posterior leukoencephalopathy (RPLS) occurs along w/ control of HTN & administration of supportive management. Temporarily interrupt treatment in patients undergoing major surgery. Consider dose reduction/interruption or permanent discontinuation if severe or persistent hand-foot skin reaction & rash occurs. Patients who have received prior sorafenib therapy. Asian (especially Japanese). Women of childbearing potential & men should ensure effective contraception during & up to 8 wk after treatment. Pregnancy & lactation. 
Adverse Reactions
Pain, hand-foot skin reaction, asthenia/fatigue, diarrhea, decreased appetite & food intake, HTN & infection. Thrombocytopenia, anemia; hemorrhage; dysphonia; stomatitis, vomiting, nausea; hyperbilirubinemia, increased transaminases; rash; pain, fever, mucosal inflammation; wt loss. Leukopenia; hypothyroidism; hypokalemia, hypophosphatemia, hypocalcemia, hyponatremia, hypomagnesemia, hyperuricemia; headache, tremor; taste disorders, dry mouth, gastroesophageal reflux, gastroenteritis; dry skin, exfoliative rash; muscle spasm; proteinuria; increase in amylase, lipase, abnormal INR.
Drug Interactions
Increased mean exposure w/ ketoconazole. Changes in mean exposure w/ strong CYP3A4 inducers (eg, rifampin) & inhibitors (eg, clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin & voriconazole). May increase AUC of irinotecan.
ATC Classification
L01EX05 - regorafenib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Stivarga FC tab 40 mg
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