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Sorafenib Dosage

Medically reviewed on January 25, 2018.

Applies to the following strengths: 200 mg

Usual Adult Dose for Renal Cell Carcinoma

400 mg orally 2 times a day
Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
-The tablets should be swallowed with a glass of water.

Uses:
-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC
-Renal Cell Carcinoma (RCC): For patients with advanced RCC
-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Usual Adult Dose for Thyroid Cancer

400 mg orally 2 times a day
Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
-The tablets should be swallowed with a glass of water.

Uses:
-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC
-Renal Cell Carcinoma (RCC): For patients with advanced RCC
-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Usual Adult Dose for Hepatocellular Carcinoma

400 mg orally 2 times a day
Duration of therapy: Until the patient is no longer benefiting from therapy or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach, at least 1 hour before or 2 hours after food.
-The tablets should be swallowed with a glass of water.

Uses:
-Hepatocellular Carcinoma (HCC): For patients with unresectable HCC
-Renal Cell Carcinoma (RCC): For patients with advanced RCC
-Differentiated Thyroid Carcinoma (DTC): For patients with locally recurrent or metastatic, progressive, DTC that is refractory to radioactive iodine treatment

Renal Dose Adjustments

Mild, moderate, or severe renal impairment: No adjustment recommended.

Liver Dose Adjustments

Child-Pugh A or B: No adjustment recommended.
Child-Pugh C: Data not available

Dose Adjustments

Temporary interruption of therapy is recommended in patients undergoing major surgical procedures.

Temporary interruption or permanent discontinuation of therapy may be required for the following:
-Cardiac ischemia or infarction
-Hemorrhage requiring medical intervention
-Severe or persistent hypertension despite adequate anti-hypertensive therapy
-GI perforation
-QTc prolongation
-Severe drug-induced liver injury

Dose modifications for hepatocellular carcinoma (HCC) and renal cell carcinoma (RCC):
-First dose reduction: 400 mg once daily
-Second dose reduction: 400 mg every other day

Dose modifications for dermatologic toxicity for patients with HCC or RCC:
DERMATOLOGIC TOXICITY GRADE 1 - Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema, or discomfort of the hands or feet which does not disrupt normal activities:
-Suggested dose modification for any occurrence: Continue therapy and consider topical therapy for symptomatic relief.
-DERMATOLOGIC TOXICITY GRADE 2 - Painful erythema and swelling of the hands or feet and/or discomfort affecting normal activities:
-Suggested dose modification for the first occurrence: Continue therapy and consider topical treatment for symptomatic relief.
-Suggested dose modification for the second or third occurrence or if there is no improvement within 7 days: Interrupt therapy until toxicity resolves to Grade 0 or 1; when resuming therapy, decrease the dose by one dose level (to 400 mg once daily or 400 mg once every other day).
-Suggested dose modification for the fourth occurrence: Discontinue therapy
-DERMATOLOGIC TOXICITY GRADE 3 - Moist desquamation, ulceration, blistering, or severe pain of the hands or feet, or severe discomfort that interferes with patient ability to work or perform activities of daily living:
-Suggested dose modification for the first or second occurrence: Interrupt therapy until toxicity resolves to Grade 1 or 0; when resuming therapy, decrease the dose by one dose level (to 400 mg once daily or 400 mg once every other day).
-Suggested dose modification for the third occurrence: Discontinue therapy

Dose modifications for differentiated thyroid carcinoma (DTC):
-First dose reduction: 600 mg daily dose (400 mg and 200 mg 12 hours apart)
-Second dose reduction: 200 mg twice daily
-Third dose reduction: 200 mg once daily

Dose modifications for dermatologic toxicity for patients with DTC:
DERMATOLOGIC TOXICITY GRADE 1 - Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema, or discomfort of the hands or feet which does not disrupt normal activities:
-Suggested dose modification for any occurrence: Continue therapy
-DERMATOLOGIC TOXICITY GRADE 2 - Painful erythema and swelling of the hands or feet and/or discomfort affecting normal activities:
-Suggested dose modification for the first occurrence: Decrease dose to 600 mg daily
-Suggested dose modification for no improvement within 7 days at reduced dose OR second occurrence: Interrupt therapy until toxicity resolves to Grade 1; if therapy is resumed, decrease the dose to 200 mg twice daily
-Suggested dose modification for the third occurrence: Reduce dose to 200 mg once daily
-Suggested dose modification for the fourth occurrence: Discontinue therapy permanently.
-DERMATOLOGIC TOXICITY GRADE 3 - Moist desquamation, ulceration, blistering, or severe pain of the hands or feet, or severe discomfort that interferes with patient ability to work or perform activities of daily living:
-Suggested dose modification for the first occurrence: Interrupt therapy until toxicity resolves to Grade 1; if therapy is resumed, decrease the dose by one dose level (to 600 mg daily dose [400 mg and 200 mg 12 hours apart])
-Suggested dose modification for the second occurrence: Interrupt therapy until toxicity resolves to Grade 1; when therapy is resumed, decrease the dose by 2 dose levels (200 mg twice daily)
-Suggested dose modification for the third occurrence: Discontinue therapy permanently.

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients
-In patients with squamous cell lung cancer

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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