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Disease specific warnings: Differentiated thyroid cancer (DTC): Before initiating treatment, physicians are recommended to carefully evaluate the prognosis in the individual patient considering maximum lesion size (see Pharmacology: Pharmacodynamics under Actions), symptoms related to the disease (see Pharmacology: Pharmacodynamics under Actions) and progression rate.
Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy. In study 5 (see Pharmacology: Pharmacodynamics under Actions), 37% of subjects had dose interruption and 35% had dose reduction already in cycle 1 of sorafenib treatment.
Dose reductions were only partially successful in alleviating adverse reactions. Therefore repeat evaluations of benefit and risk is recommended taking anti-tumour activity and tolerability into account.
Haemorrhage in DTC: 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 DTC.
Hypocalcaemia in DTC: When using sorafenib in patients with DTC, close monitoring of blood calcium level is recommended. In clinical trials, hypocalcaemia was more frequent and more severe in patients with DTC, especially with a history of hypoparathyroidism, compared to patients with renal cell or hepatocellular carcinoma. Hypocalcaemia grade 3 and 4 occurred in 6.8% and 3.4% of sorafenib-treated patients with DTC (see Adverse Reactions). Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes (see QT interval prolongation under Precautions).
TSH suppression in DTC: In study 5 (see Pharmacology: Pharmacodynamics under Actions), increases in TSH levels above 0.5mU/L were observed in sorafenib treated patients. When using sorafenib in DTC patients, close monitoring of TSH level is recommended.
Renal cell carcinoma: High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in Pharmacology: Pharmacodynamics under Actions), and benefit-risk in these patients has not been evaluated.
