Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Recommended Dose: 400 mg (2 tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Dosage Adjustments: Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy.
When dose reduction is necessary during the treatment of HCC and RCC, the dose should be reduced to 2 tablets of sorafenib 200 mg once daily (see Precautions).
When dose reduction is necessary during the treatment of DTC, the dose should be reduced to sorafenib 600 mg daily in divided doses (2 tablets of 200 mg and 1 tablet of 200 mg 12 hrs apart).
If additional dose reduction is necessary, Nexavar may be reduced to sorafenib 400 mg daily in divided doses (2 tablets of 200 mg 12 hrs apart) and if necessary, further reduced to 1 tablet of 200 mg once daily. After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased.
Renal Impairment: No dose adjustment is required in patients with mild, moderate or severe renal impairment.
No data is available in patients requiring dialysis (see Pharmacology: Pharmacokinetics under Actions).
Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Hepatic Impairment: No dose adjustment is required in patients with Child-Pugh A or B (mild to moderate) hepatic impairment. No data is available on patients with Child-Pugh C (severe) hepatic impairment
(see Pharmacology: Pharmacokinetics under Actions and Precautions).
Elderly: No dose adjustment is required in the elderly (patients >65 years).
Administration: For oral use.
It is recommended that sorafenib should be administered without food or with a low or moderate fat meal. If the patient intends to have a high-fat meal, sorafenib tablets should be taken at least 1 hr before or 2 hrs after the meal. The tablets should be swallowed with a glass of water.