Nexavar Dosage/Direction for Use

Recommended Daily Dose: 400 mg (2 x 200 mg tablets) taken twice a day, either without food or together with a low fat or moderate fat meal.
Duration of Treatment: Treatment should be continued until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.
Dose Titration, Dose Adjustment, Special Monitoring Advice: Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction of sorafenib therapy. When dose reduction is necessary, the sorafenib dose should be reduced to 2 tablets of 200 mg once daily (see Precautions).
Suggested dose modifications for skin toxicity are shown in Table 2.

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Special Populations: Pediatric Patients: The safety and effectiveness of sorafenib in pediatric patients has not been established.
Elderly (>65 years), Gender and Body Weight: No dose adjustment is required on the basis of patient age (>65 years), gender or body weight.
Hepatic Impairment: No dose adjustment is required in patients with Child-Pugh A and B hepatic impairment. Sorafenib has not been studied in patients with Child-Pugh C hepatic impairment (see Hepatic Impairment in Special Populations under Actions).
Renal Impairment: No dose adjustment is required in patients with mild, moderate or severe renal impairment not requiring dialysis. Sorafenib has not been studied in patients undergoing dialysis (see Renal Impairment in Special Populations under Actions).
Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Administration: For oral use. To be swallowed with a glass of water.