Generic Name and Formulations:
Regorafenib 40mg; tabs.
- FDA Approves Regorafenib for Second-line in Hepatocellular Carcinoma
- FDA Grants Priority Review to Regorafenib for Liver Cancer
- Supplemental New Drug Application Submitted for Regorafenib for Treatment of HCC
- Hepatocellular Carcinoma Treatment Regimens
- Gallbladder Carcinoma and Intrahepatic Cholangiocarcinoma Treatment Regimens
- Anal Cancer Treatment Regimens
Indications for STIVARGA:
Metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy. Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) in patients who have been previously treated with imatinib mesylate or sunitinib malate. Hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
Swallow whole with water after a low-fat meal (contains <600 calories and <30% fat). 160mg once daily for the first 21 days of each 28-day cycle; until disease progression or unacceptable toxicity. Dose modifications: reduce by 40mg increments (see full labeling).
<18yrs: not established.
Risk of severe liver injury (may be fatal). Obtain LFTs before starting and at least every 2 weeks during first 2 months of treatment; interrupt and reduce or discontinue if persistent hepatotoxicity or hepatocellular necrosis occurs. Severe hepatic impairment: not recommended. Increased risk of infections; withhold if Grade 3/4 occurs or infection of any grade worsens; resume when resolved. Permanently discontinue if severe or life-threatening hemorrhage occurs. Interrupt and reduce or permanently discontinue if dermatological toxicity occurs (eg, hand-foot skin reaction [a.k.a. palmar-plantar erythrodysesthesia], rash). Ensure BP is controlled before starting; monitor weekly for the first 6 weeks then every cycle or as clinically indicated; withhold if severe or uncontrolled. Increased risk of myocardial ischemia/infarction: withhold if new or acute onset develops; resume when resolved. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) or GI perforation/fistula develops. Wound healing complications: stop treatment at least 2 weeks before surgery; discontinue if wound dehiscence occurs. Asian patients (monitor). Dialysis. Embryo-fetal toxicity. Females and males of reproductive potential should use effective contraception during treatment and up to 2 months after completion. Pregnancy. Nursing mothers: not recommended (during and for 2 weeks after final dose).
Potentiated by strong CYP3A4 inhibitors (eg, clarithromycin, grapefruit juice, itraconazole, ketoconazole, nefazodone, posaconazole, telithromycin, voriconazole); avoid. Antagonized by strong CYP3A4 inducers (eg, rifampin, phenytoin, carbamazepine, phenobarbital, St. John’s Wort); avoid. Potentiates BCRP substrates (eg, methotrexate, fluvastatin, atorvastatin); monitor closely. Monitor INR levels with concomitant warfarin.
Asthenia/fatigue, decreased appetite and food intake, hand-foot skin reaction, diarrhea, mucositis, weight loss, infection, hypertension, dysphonia, hyperbilirubinemia, GI and abdominal pain, rash, fever, nausea; hepatotoxicity, hemorrhage, GI perforation, cardiac ischemia/infarction, RPLS.
Hepatic (CYP3A4, UGT1A9); 99.5% protein bound.
Fecal (major), renal.
Tabs—84 (3 x 28)
Sign Up for Free e-newsletters
Regimen and Drug Listings
GET FULL LISTINGS OF TREATMENT Regimens and Drug INFORMATION
|Head and Neck Cancer||Regimens||Drugs|
|Renal Cell Carcinoma||Regimens||Drugs|
Cancer Therapy Advisor Articles
- Alcohol Consumption and Cancer
- Pancreatitis and the Risk of Cancer
- RAMIE May Improve Post-operative Outcomes Among Patients With Esophageal Cancer
- Hyperthermic Intraperitoneal Chemotherapy With Cytoreductive Surgery Prolongs OS in Gastric Cancer
- Renal Cell Carcinoma: Cost of Treatment May Negate Impact of Treatment Advances
- Depressed Patients With Head and Neck Cancer May Have Higher Mortality Rates
- MSK1 Levels Associated With Relapse, Metastasis in ER-positive Breast Cancer
- In the Clinic: Managing Malignant Pleural Effusions
- Does Depression Increase the Risk for Mortality Among Patients With Cancer?
- Nivolumab With Ipilimumab Promising for Pretreated Metastatic Sarcoma