Sorafenib Tablets IP 200mg

Sorafekast (Sorafenib 200mg)GENERIC NAME:Sorafenib Tablets LP. 200 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:Each film-coated tablet contains: Sorafenlb tosylate IP Equivalent to Sorafeni x me Exclplents …
Colours: Feric oxide Red usr. NF. Titanium Dioxide IP.
The used are rystal Ge G Sodium, Sodium Lauryi Sulphate, Magnesium stearate, Titanium Dioxide, Macrogol/PEG and Ferric Oxide Red'.
DOSAGE FORM AND STRENGTH:-Oral (Fllm-coated tablets) and 200 mg
4. CLINICAL PARTICULARS:
4.1 Therapeutic Indication
For the treatment of patients with advanced renal cell carcinoma (RCC).
For hepatocellular Carcinoma (HCC).
For the treatment of patients with locally advanced or metastatic differentiated thyroid carcinoma
(DTC) refractory to radioactive iodine.
4.2 Posology and mathod of administration
Sorafenib treatment should be supervised by a physician experienced in the use of anticancer therapies.
The recommended dose of sorafenib in adults is 400 mg (two tablets of 200 mg) twice daily (equivalent to a total dally dose of 800 mg).
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
When dose Is ry during the (HCC) and advanced renal cell carcinoma (RCC), the sorafenib dose snow be reduced to two tablets of 200 mg sorafenib once dally.
When dose ion is Y¥ during the of diffe i thyroid (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 200mg once daily.
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 dese 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 avallable on patients with Child Pugh C (severe) hepatic Impairment. may require temporary interruption or dose reduction
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.