Active Ingredient: Sorafenib
Sorafenib is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hรผrthle cell) thyroid carcinoma, refractory to radioactive iodine.
For this indication, competent medicine agencies globally authorize below treatments:
Oral
800 - 800 mg
From 400 To 400 mg 2 time(s) per day every day
The recommended dose of sorafenib in adults is 400 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 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.
If additional dose reduction is necessary, sorafenib may be reduced to 400 mg sorafenib daily in divided doses, 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.
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 should be taken at least 1 hour before or 2 hours after the meal.
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