Sorafenat 200 Dosage/Direction for Use

Sorafenib treatment should be supervised by a physician experienced in the use of anticancer therapies.
Posology: The recommended dose of sorafenib in adults is 400 mg Sorafenib (two 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.
Posology 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 hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the sorafenib dose should be reduced to two tablets of 200 mg sorafenib once daily (see Precautions).
When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the sorafenib dose should be reduced to 600 mg sorafenib daily in divided doses (two tablets of 200 mg and one tablet of 200 mg twelve hours apart).
If additional dose reduction is necessary, sorafenib may be reduced to one tablet of 200 mg twice daily, followed by one tablet of 200 mg once daily. After improvement of non-hematological adverse reactions, the dose of sorafenib may be increased.
Paediatric population: The safety and efficacy of sorafenib in children have not yet been established. No data are available.
Elderly population: No dose adjustment is required in the elderly (patients above 65 years of age).
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 Precautions and Pharmacology: Pharmacokinetics under Actions).
Method of 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 hour before or 2 hours after the meal. The tablets should be swallowed with a glass of water.