Firma Chun Cheong
Concise Prescribing Info
Monotherapy for the treatment of adult patient w/ metastatic colorectal cancer (CRC) who have been previously treated w/, or are not considered candidates for, available therapies (including fluoropyrimidine-based chemotherapy, an antivascular endothelial growth factor (anti-VEGF) therapy & an anti-EGFR therapy); unresectable or metastatic GI stromal tumours who progressed on or are intolerant to prior treatment w/ imatinib & sunitinib; hepatocellular carcinoma (HCC) who have been previously treated w/ sorafenib.
Dosage/Direction for Use
160 mg (four 40-mg tab) once daily for 3 wk followed by 1 wk off therapy to comprise a treatment cycle of 4-wk period.
Should be taken with food: Take at the same time each day w/ a low-fat meal (<30% fat).
Special Precautions
Abnormalities of liver function tests. Perform liver function tests (ALT, AST & bilirubin) before treatment initiation, closely monitor during the 1st 2 mth of treatment, & periodic monitoring at least mthly thereafter & as clinically indicated. Risk of mild, indirect (unconjugated) hyperbilirubinaemia in patients w/ Gilbert's syndrome. Increased incidence of infection events; haemorrhagic events; myocardial ischaemia & infarction; arterial HTN; electrolyte & metabolic abnormalities. Risk of GI perforation & fistulae; posterior reversible encephalopathy syndrome (PRES); hand-foot skin reaction (HFSR) or palmar-plantar erythrodysesthesia syndrome & rash. Control BP prior to treatment initiation. May suppress or interfere w/ wound healing. Recommended to temporary interrupt treatment in patients undergoing major surgical procedures. Patients w/ mild or moderate hepatic impairment. Not recommended in patients w/ severe hepatic impairment (Child-Pugh C). Patients on controlled Na diet. Contains lecithin. May cause foetal harm. Women of childbearing potential & men should ensure effective contraception during treatment & up to 8 wk after completion of therapy. Pregnancy & lactation. Paed population. Hepatocellular carcinoma: Patients who received prior therapy w/ sorafenib.
Adverse Reactions
Infection; thrombocytopenia, anaemia; decreased appetite & food intake; haemorrhage, HTN; dysphonia; diarrhoea, stomatitis, vomiting, nausea; hyperbilirubinaemia, increase in transaminases; hand-foot skin reaction, rash; asthenia/fatigue, pain, fever, mucosal inflammation; wt loss. Leucopenia; hypothyroidism; hypokalaemia, hypophosphatemia, hypocalcaemia, hyponatraemia, hypomagnesaemia, hyperuricaemia, dehydration; headache, tremor, peripheral neuropathy; taste disorders, dry mouth, gastro-oesophageal reflux, gastroenteritis; alopecia, dry skin, exfoliative rash; muscle spasms; proteinuria; increase in amylase, increase in lipase, abnormal INR.
Drug Interactions
Avoid concomitant use w/ strong CYP3A4 inhibitors (eg, clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole); strong UGT1A9 inhibitors (eg, mefenamic acid, diflunisal, niflumic acid). Reduced AUC of regorafenib w/ strong CYP3A4 inducer (eg, rifampicin, phenytoin, carbamazepine, phenobarb & St. John's wort). May increase systemic exposure to UGT1A1 & UGT1A9 substrates. May increase plasma conc of BCRP substrates (eg, rosuvastatin, methotrexate, fluvastatin, atorvastatin). BCRP & P-glycoprotein inhibitors & inducers may interfere w/ exposure of M-2 & M-5 active metabolites of regorafenib. Potential decrease in efficacy w/ neomycin, or bile salt-sequestering agent (eg, cholestyramine, cholestagel).
ATC Classification
L01XE21 - regorafenib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Stivarga FC tab 40 mg
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