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Essential Information Name of the medicinal product : Nexavar® 200 mg film-coated tablets. Qualitative and quantitative composition: 200 mg sorafenib (as tosylate) Indication: 1. Treatment of hepatocellular carcinoma. 2. Treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Contraindications: Hypersensitivity to sorafenib or to any of the excipients. Warnings and Precautions: Hand-foot skin reaction and rash, usually CTC grade 1 and 2. Increased incidence of arterial hypertension (usually mild to moderate, early in the course of treatment). Blood pressure should be monitored regularly and treated as appropriate. Increased risk of bleeding. Increased incidence of cardiac ischaemia/infarction. Gastrointestinal perforation in less than 1%; sorafenib to be discontinued. Levels of sorafenib may be increased in patients with severe hepatic impairment. Infrequent bleeding events or elevations in INR have been reported in some patients taking warfarin concomitantly. Patients on such kind of therapy should be monitored. Temporary treatment interruption and/or dose modification or discontinuation may be considered, depending on the severity of the observed adverse reactions. No formal studies on wound healing have been conducted. Temporary interruption of Nexavar® therapy is recommended in patients undergoing major surgical procedures. Experience of use in the elderly is limited and cases of renal failure have been reported. High risk patients according to MSKCC prognostic group were not included in the phase III study in renal cell carcinoma and benefit-risk has not been evaluated in these patients. Caution is recommended when administering Nexavar® with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways. Decreased plasma concentrations of sorafenib cannot be excluded with concomitant administration of anti-acidic medicinal products. Caution is recommended when sorafenib is co-administered with docetaxel. Undesirable effects: Very common: lymphopenia, hypophosphataemia, haemorrhage (incl. gastrointestinal, respiratory tract, cerebral), hypertension, diarrhoea, nausea, vomiting, rash, alopecia, hand-foot syndrome (palmar plantar erythrodysaesthesia syndrome), erythema, pruritus, fatigue, pain (mouth, abdominal, bone, tumour, headache), increased amylase and lipase. Common: leucopenia, neutropenia, anaemia, thrombocytopenia, anorexia, depression, peripheral sensory neuropathy, tinnitus, hoarseness, constipation, stomatitis (including dry mouth and glossodynia), dyspepsia, dysphagia, dry skin, dermatitis exfoliative, acne, skin desquamation, arthralgia, myalgia, erectile dysfunction, asthenia, fever, influenza like illness, weight decrease, transient increase in transaminases. Uncommon: folliculitis, infection, hypersensitivity reactions (including skin reactions and urticaria), hypothyroidism, hyponatraemia, dehydration, reversible posterior leukoencephalopathy, myocardial ischaemia and infarction, congestive heart failure, hypertensive crisis, rhinorrhea, gastro oesophageal reflux disease, pancreatitis, gastritis, gastrointestinal perforations, increase in bilirubin, jaundice, cholecystitis, cholangitis, eczema, erythema multiforme minor, keratoacanthoma / squamous cell cancer of the skin, gynaecomastia, increase in alkaline phosphatase, INR abnormality, prothrombin level abnormality. On prescription only. Date of Revision of the Text: April 2008. Please note! For current prescribing information, refer to the package insert. Term Explanation for term. |
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