Indications, posology and method of administration
THERAPEUTIC INDICATIONS
Hepatocellular carcinoma:
Sorafenib is indicated for the treatment of hepatocellular carcinoma.
Renal cell carcinoma:
Sorafenib 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:
Sorafenib is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, refractory to radioactive iodine.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The recommended dose of sorafenib in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily.
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.
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 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 sorafenib may be increased.
Paediatric population:
The safety and efficacy of sorafenib 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.
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 .
Method of administration:
For oral use, The tablets should be swallowed with a glass of water..
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.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
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