Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bayer AG, 51368, Leverkusen, Germany
Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).
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.
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.
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.
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.
The safety and efficacy of Nexavar in children and adolescents aged <18 years have not yet been established. No data are available.
No dose adjustment is required in the elderly (patients above 65 years of age).
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.
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).
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.
There is no specific treatment for sorafenib overdose. The highest dose of sorafenib studied clinically is 800 mg twice daily. The adverse events observed at this dose were primarily diarrhoea and dermatological events. In the event of suspected overdose sorafenib should be withheld and supportive care instituted where necessary.
3 years.
Do not store above 25°C.
112 film-coated tablets (4 × 28) in transparent (PP/Aluminium) blister packs.
This medicinal product could have potential risk for the environment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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