Hepatocellular carcinoma (HCC)

Indication for Sorafenib

Population group: Suitable for both men and women, only adults (18 years old or older)

Sorafenib is indicated for the treatment of hepatocellular carcinoma.

For this indication, competent medicine agencies globally authorize below treatments:

800 mg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

800 - 800 mg

Dosage regimen

From 400 To 400 mg 2 time(s) per day every day

Detailed description

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.

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 daily in divided doses.

If additional dose reduction is necessary, sorafenib may be reduced to 400 mg 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.

Dosage considerations

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.

Active ingredient

Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo. Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-β).

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