Pricing
Prices are indicative MRP and may vary by pharmacy. Trend compares against the last recorded price.
All price changes →Indications & Uses
Colorectal Cancer: Reganex is indicated for the treatment of patients with metastatic colorectal cancer (CRC) 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 ... Read moreColorectal Cancer: Reganex is indicated for the treatment of patients with metastatic colorectal cancer (CRC) 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.Gastrointestinal Stromal Tumors: Reganex is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with Imatinib Mesylate and Sunitinib Malate.Hepatocellular Carcinoma: Reganex is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with Sorafenib.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose is 160 mg Regorafenib (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Treatment should be continued until disease progression or unacceptable toxicity. Regorafenib should be taken at the same time each day and swallowed tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat. Two doses of Regorafenib should not be taken on the same day to make up for a missed dose from the previous day.Dose Modifications: If dose modifications are required, the dose should be reduced in 40 mg (one tablet) increments; the lowest recommended daily dose of Regorafenib is 80 mg daily. Or, as directed by the registered physicians.Pediatric Use: The safety and efficacy of Regorafenib in pediatric patients less than 18 years of age have not been established.
Side Effects
Hepatotoxicity Infections Hemorrhage Gastrointestinal Perforation or Fistula Dermatological Toxicity Hypertension Cardiac Ischemia and Infarction Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
Cautions & Contraindications
Warnings & Precautions
Hepatotoxicity: Severe drug-induced liver injury with fatal outcome occurred in Reganex- treated patients in clinical trials. In most cases, liver dysfunction occurred within the first 2 months of therapy and was characterized by a hepatocellular pattern of injury. Liver function tests (ALT, AST, and bilirubin) should be obtained before initiation of Reganex and monitored at least every two weeks during the first 2 months of treatment. Reganex should be temporarily held and then reduced or permanently discontinued depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis.Infections: Reganex caused an increased risk of infections. The most common infections were urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) and pneumonia (2.6%). Fatal outcomes caused by infection occurred more often in patients treated with Reganex (1.0%) as compared to patients receiving placebo (0.3%); the most common fatal infections were respiratory (0.6% in Reganex- treated patients vs 0.2% in patients receiving placebo). Reganex should be withheld for Grade 3 or 4 infections, or worsening infection of any grade. Reganex should be resumed at the same dose following resolution of infection.Hemorrhage: Reganex caused an increased incidence of hemorrhage. The incidence of fatal hemorrhagic events was 0.7%, involving the central nervous system or the respiratory, gastrointestinal, or genitourinary tracts. Reganex should be permanently discontinued in patients with severe or life-threatening hemorrhage. INR levels should be monitored more frequently in patients receiving Warfarin.Gastrointestinal Perforation or Fistula: Gastrointestinal perforation occurred in 0.6% of 4518 patients treated with Reganex across all clinical trials of Reganex administered as a single agent; this included eight fatal events. Reganex should be permanently discontinued in patients who develop gastrointestinal perforation or fistula.Dermatologic Toxicity: A higher incidence of Hand-foot skin reaction (HFSR) was observed in Asian patients treated with Reganex (all grades: 72%; Grade 3: 18%). Reganex should be withheld, reduced the dose, or permanently discontinued Reganex depending on the severity and persistence of dermatologic toxicity. Supportive measures for symptomatic relief should be instituted.Hypertension: Reganex caused an increased incidence of hypertension (30% versus 8% in CORRECT, 59% versus 27% in GRID, and 31% versus 6% in RESORCE). The onset of hypertension occurred during the first cycle of treatment in most patients who developed hypertension (67% in randomized, placebo-controlled trials). Reganex should not be initiated unless blood pressure is adequately controlled, monitored blood pressure weekly for the first 6 weeks of treatment and then every cycle, or more frequently, as clinically indicated. Reganex should be temporarily or permanently withheld for severe or uncontrolled hypertension.Cardiac Ischemia and Infarction: Reganex increased the incidence of myocardial ischemia and infarction (0.9%vs 0.2%) in randomized placebo-controlled trials. Reganex should be withheld in patients who develop new or acute onset cardiac ischemia or infarction. Reganex should be resumed only after resolution of acute cardiac ischemic events, if the potential benefits outweigh the risks of further cardiac ischemia. Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Reversible posterior leukoencephalopathy syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in one of 1200 Reganex- treated patients across all clinical trials. An evaluation for RPLS should be performed in any patient presenting with seizures, severe headache, visual disturbances, confusion or altered mental function. Reganex should be discontinued in patients who develop RPLS.Wound Healing Complications: No formal studies of the effect of Reganex on wound healing have been conducted. Since vascular endothelial growth factor receptor (VEGFR) inhibitors such as Reganex can impair wound healing, discontinue treatment with Reganex atleast 2 weeks prior to scheduled surgery. The decision to resume Reganex after surgery should be based on clinical judgment of adequate wound healing. Reganex should be discontinued in patients with wound dehiscence.Embryo-Fetal Toxicity: There are no available data on Reganex use in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Females of reproductive potential should be advised to use effective contraception during treatment with Reganex and for 2 months after the final dose. Males with female partners of reproductive potential should be advised to use effective contraception during treatment with Reganex and for 2 months after the final dose.
Contraindications
It is contraindicated in patients with known hypersensitivity to Regorafenib or any other components of this product.