Composition
Tab: Regorafenib 40 mg
Indications & Dosage
Metastatic colorectal cancer, Unresectable or metastatic gastrointestinal stromal tumours, Hepatocellular carcinoma (specialist use only): Adult: 160 mg once daily for 21 consecutive days of repeated 28-day cycles, for dose adjustment consult product literature.
Precautions
Hepatic or renal impairment, ensure measures to prevent hand-foot skin reaction, Gilbert’s syndrome; risk of hyperbilirubinaemia, history of ischaemic heart disease—monitor and interrupt treatment if signs of ischaemia or infarction develop, hypertension, may impair wound healing; withhold treatment for major surgical procedures, predisposition to bleeding, risk factors for aneurysm or artery dissection. Monitor blood count and coagulation parameters and consider discontinuation in event of severe bleeding. Monitor hepatic function before treatment then at least every two weeks for the first 2 months, consult product literature if changes in liver function observed. Monitor for signs and symptoms of posterior reversible encephalopathy syndrome (including seizure, headache, altered mental status, visual disturbances or cortical blindness, with or without hypertension) discontinue treatment if symptoms occur. Monitor biochemical, electrolyte and metabolic parameters during treatment.
Interactions
Antiarrhythmics, Antiepileptics, Antifungals, azoles, non-sedating antihistamines, Aprepitant, Calcium channel blockers, ciclosporin, Cobicistat, colchicine, Coumarins (warfarin), Crizotinib, dabigatran, digoxin, edoxaban, Enzalutamide, ergotamine, everolimus, H2 receptor antagonists, Tacrolimus,Taxanes, topotecan
Pregnancy
Avoid unless essential
Lactation
Contraindicated. Discontinue breast-feeding
Side Effects
Alopecia, anaemia, appetite, decreased, asthenia, diarrhoea, dry mouth, dysphonia, electrolyte imbalance, fever, gastrooesophageal reflux disease, headache, hyperbilirubinaemia, hypertension, hyperuricaemia, hypothyroidism, increased risk of infection, leucopenia, mucositis, musculoskeletal stiffness, nausea, pain, proteinuria, skin reactions, stomatitis, athrombocytopenia, tremor, vomiting, weight loss. Rare: GI fistula(discontinue), GI perforation (discontinue), hepatic disorders, myocardial infarction, myocardial ischaemia, nail disorder, Neoplasms.posterior reversible encephalopathy syndrome (PRES), severe cutaneous adverse reactions (SCARs), aneurysm.artery dissection.