Nexavar 200 mg film-coated tablets
Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
For the full list of excipients, see section 6.1.
Film-coated tablet (tablet).
Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side.
Hepatocellular carcinoma
Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).
Renal cell carcinoma
Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Differentiated thyroid carcinoma
Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Posology
The recommended dose of Nexavar 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 Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4).
When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the Nexavar 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, Nexavar may be reduced to 400 mg sorafenib daily in divided doses (two tablets of 200 mg twelve hours apart), and if necessary further reduced to one tablet of 200 mg once daily. After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased.
Paediatric population
The safety and efficacy of Nexavar in children and adolescents aged < 18 years 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 section 5.2).
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 sections 4.4 and 5.2).
Method of administration
For oral use.
It is recommended that sor
