Drug Action
Regorafenib is an inhibitor of several protein kinases.
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Drug reference
Regorafenib is an inhibitor of several protein kinases.
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Metastatic colorectal cancer (specialist use only) | Unresectable or metastatic gastrointestinal stromal tumours (specialist use only) | Hepatocellular carcinoma (specialist use only) ▶BY MOUTH ▶Adult: 160 mg once daily for 21 consecutive days of repeated 28-day cycles, for dose adjustment due to side effects—consult product literature
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Ensure measures to prevent hand-foot skin reaction. Gilbert’s syndrome—risk of hyperbilirubinaemia . history of ischaemic heart disease—monitor for signs and symptoms of myocardial ischaemia and interrupt treatment if signs of ischaemia or infarction develop. hypertension—control blood pressure before treatment initiation and monitor as clinically indicated during treatment (review dose and consider treatment interruption if severe or persistent hypertension develops; discontinue treatment if hypertensive crisis occurs). may impair wound healing— withhold treatment for major surgical procedures. predisposition to bleeding
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NICE decisions ▶Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours (November 2017) NICE TA488 Regorafenib (Stivarga ®) is recommended as an option for treating unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib, only if: . their Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1, and Immune system and malignant disease . the manufacturer provides regorafenib with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta488 ▶Regorafenib for previously treated advanced hepatocellular carcinoma (January 2019) NICE TA555 Regorafenib (Stivarga ®) is recommended as an option for treating advanced unresectable hepatocellular carcinoma in adults who have had sorafenib, only if: . they have Child–Pugh grade A liver impairment and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and . the manufacturer provides it according to the commercial arrangement. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta555 Scottish Medicines Consortium (SMC) decisions SMC No. 1316/18 The Scottish Medicines Consortium has advised (May 2018) that regorafenib (Stivarga ®) is accepted for use within NHS Scotland as monotherapy for the treatment of adults with hepatocellular carcinoma who have been previously treated with sorafenib. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: regorafenib Immune system and malignant disease
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▶Common or very common 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. taste altered. thrombocytopenia. tremor. vomiting. weight decreased ▶Uncommon Gastrointestinal fistula (discontinue). gastrointestinal perforation (including fatal cases, discontinue). hepatic disorders. myocardial infarction. myocardial ischaemia. nail disorder ▶Rare or very rare Neoplasms. posterior reversible encephalopathy syndrome (PRES). severe cutaneous adverse reactions (SCARs)
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Women of childbearing potential and men must use effective contraception during treatment and up to 8 weeks after last dose.
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Manufacturer advises avoid unless potential benefit outweighs risk—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Avoid—present in milk in animal studies.
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Manufacturer advises caution in moderate impairment (limited information available); avoid in severe impairment (no information available).
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Caution in severe impairment—no information available.
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▶Monitor blood count and coagulation parameters and consider permanent discontinuation in event of severe bleeding. ▶Monitor hepatic function before treatment, then at least every two weeks for the first 2 months, then at least monthly thereafter and as clinically indicated—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; ensure measures to prevent hand-foot skin reaction—consult product literature if signs or symptoms develop.
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Tablets should be taken at the same time each day, swallowed whole with water after a light meal that contains less than 30% fat.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 21 ELECTROLYTES: May contain Sodium ▶Stivarga (Bayer Plc) Regorafenib 40 mg Stivarga 40mg tablets | 84 tablet P £3,744.00 (Hospital only)
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Counselling advised (administration).
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160 mg once daily for 21 consecutive days of
First-line fragment. Read the complete Indications and Dose section above.
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