Nexavar® 200 mg film-coated tablets.
Qualitative and quantitative composition: 200 mg sorafenib (as tosylate)
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. Use sorafenib with caution in patients who may have, or may develop prolongation of QTc, and consider periodic monitoring (on-treatment electrocardiograms, electrolytes). 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 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 sorafenib therapy is recommended in patients undergoing major surgical procedures. In elderly 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 sorafenib with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways. Caution is recommended when sorafenib is co-administered with docetaxel. The risk of reduced plasma concentrations of sorafenib should be considered before starting a treatment course with antibiotics. Higher mortality has been reported in patients with squamous cell carcinoma of the lung with sorafenib in combination with platinum-based chemotherapies. Due to the potential risk of bleeding, tracheal, bronchial, and oesophageal infiltration should be treated with localized therapy prior to administering sorafenib in patients with differentiated thyroid cancer (DTC). When using sorafenib in patients with DTC, close monitoring of blood calcium level is recommended. Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes. When using sorafenib in DTC patients, close monitoring of TSH level is recommended.
Undesirable effects: Very common: infection, lymphopenia, anorexia, hypophosphataemia, haemorrhage (incl. gastrointestinal, respiratory tract, cerebral), hypertension, diarrhoea, nausea, vomiting, constipation, dry skin, rash, alopecia, hand-foot skin reaction (palmar plantar erythrodysaesthesia syndrome), erythema, pruritus, arthralgia, fatigue, pain (mouth, abdominal, bone, tumour, headache), fever, weight decreased, increased amylase and lipase. Common: folliculitis, leucopenia, neutropenia, anaemia, thrombocytopenia, hypothyroidism, hypocalcaemia, hypokalaemia, hyponatraemia, depression, peripheral sensory neuropathy, dysgeusia, tinnitus, congestive heart failure, myocardial ischemia and infarction, flushing, rhinorrhea, dysphonia, stomatitis (including dry mouth and glossodynia), dyspepsia, dysphagia, gastro oesophageal reflux disease, keratoacanthoma / squamous cell cancer of the skin, dermatitis exfoliative, acne, skin desquamation, hyperkeratosis, myalgia, muscle spasms, renal failure, proteinuria, erectile dysfunction, asthenia, influenza like illness, mucosal inflammation, transient increase in transaminases. Uncommon: hypersensitivity reactions (including skin reactions and urticaria), anaphylactic reaction, hyperthyroidism, dehydration, reversible posterior leukoencephalopathy, hypertensive crisis, interstitial lung disease–like events (pneumonitis, radiation pneumonitis, acute respiratory distress, etc), pancreatitis, gastritis, gastrointestinal perforations, increase in bilirubin, jaundice, cholecystitis, cholangitis, eczema, erythema multiforme, gynaecomastia, increase in alkaline phosphatase, INR abnormality, prothrombin level abnormality. Rare: Angioedema, QT prolongation, drug induced hepatitis, radiation recall dermatitis, Stevens-Johnson syndrome, rhabdomyolysis, nephrotic syndrome, toxic epidermal necrolysis, leucocytoclastic vasculitis.
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