Drug Action
Sorafenib is an inhibitor of multiple kinases.
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Drug reference
Sorafenib is an inhibitor of multiple kinases.
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Treatment of advanced renal cell carcinoma when treatment with interferon alfa or interleukin-2 has failed or is unsuitable | Treatment of progressive, locally advanced, or metastatic, differentiated thyroid carcinoma that is refractory to radioactive iodine | Treatment of hepatocellular carcinoma ▶BY MOUTH ▶Adult: 400 mg twice daily, for dose adjustments due to side effects, consult product literature
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Cardiac ischaemia. major surgical procedures. potential risk of bleeding—treat tracheal, bronchial, or oesophageal infiltration with localised therapy before initiating sorafenib in patients with differentiated thyroid carcinoma (DTC) and consider permanent withdrawal of sorafenib in any patient that requires medical intervention for bleeding. susceptibility to QT-interval prolongation
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NICE decisions ▶Bevacizumab (first-line), sorafenib (first- and second-line), sunitinib (second-line) and temsirolimus (first-line) for the treatment of advanced and/or metastatic renal cell carcinoma (August 2009) NICE TA178 Bevacizumab, sorafenib, and temsirolimus are not recommended as first-line treatments for people with advanced and/or metastatic renal cell carcinoma. Sorafenib and sunitinib are not recommended as second-line treatments for people with advanced or metastatic renal cell carcinoma. www.nice.org.uk/guidance/ta178 ▶Sorafenib for treating advanced hepatocellular carcinoma (September 2017) NICE TA474 Sorafenib is recommended as an option for treating advanced hepatocellular carcinoma only for patients with Child-Pugh grade A liver impairment, only if the manufacturer provides sorafenib within the agreed commercial access 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/ta474 ▶Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine (August 2018) NICE TA535 Sorafenib (Nexavar ®) is recommended as an option for treating progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular or Hürthle cell) in adults whose disease does not respond to radioactive iodine, only if: . they have not had a tyrosine kinase inhibitor before, or . they have had to stop taking a tyrosine kinase inhibitor within 3 months of starting it because of toxicity (specifically, toxicity that cannot be managed by dose delay or dose modification), and . the manufacturer provides sorafenib 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/ta535 Scottish Medicines Consortium (SMC) decisions SMC No. 482/08 The Scottish Medicines Consortium has advised (January 2016) that sorafenib (Nexavar ®) is accepted for restricted use within NHS Scotland for the treatment of advanced hepatocellular carcinoma in patients where surgical or loco-regional therapies have failed or are unsuitable. 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: sorafenib
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▶Common or very common Alopecia. anaemia. appetite decreased. arthralgia. asthenia. congestive heart failure. constipation. decreased leucocytes. depression. diarrhoea . dry mouth. dysphagia. dysphonia. electrolyte imbalance . erectile dysfunction. fever. flushing. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headache. hypertension. hypothyroidism. increased risk of infection. influenza like illness. intracranial haemorrhage. mucositis. muscle complaints. myocardial infarction. myocardial ischaemia. nausea. neoplasms. neutropenia. oral disorders. pain. peripheral neuropathy. proteinuria. renal failure. rhinorrhoea. skin reactions. taste altered. thrombocytopenia. tinnitus. vomiting. weight decreased ▶Uncommon Cholangitis. cholecystitis. dehydration. encephalopathy. gynaecomastia. hepatic disorders. hyperthyroidism. pancreatitis. radiation injuries. respiratory disorders ▶Rare or very rare Angioedema. hypersensitivity vasculitis. nephrotic syndrome. QT interval prolongation. rhabdomyolysis. severe cutaneous adverse reactions (SCARs)
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Contraceptive advice required, see Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless essential—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Manufacturer advises caution in severe impairment (no information available).
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▶Consider periodic monitoring of ECG and electrolytes in patients susceptible to QT-interval prolongation. ▶Monitor blood pressure regularly and consider permanent discontinuation of sorafenib if resistant to antihypertensive therapy. ▶Monitor plasma-calcium concentration (increased risk of hypocalcaemia if history of hypoparathyroidism). ▶Monitor thyroid stimulating hormone in patients with differentiated thyroid carcinoma.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 23 ▶Nexavar (Bayer Plc) Sorafenib (as Sorafenib tosylate) 200 mg Nexavar 200mg tablets | 112 tablet P £3,576.56
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400 mg twice daily, for dose adjustments due to
First-line fragment. Read the complete Indications and Dose section above.
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