Skip to Content

Sorafenib Dosage

Medically reviewed by Drugs.com. Last updated on July 13, 2020.

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:
CARDIOVASCULAR EVENTS:
CARDIAC ISCHEMIA AND/OR INFARCTION:
-Grade 2 and above: Permanently discontinue therapy.
CONGESTIVE HEART FAILURE:
-Grade 3: Interrupt therapy until Grade 1 or less; decrease one dose level (HCC and RCC: 400 mg daily, 200 mg daily, or 400 every other day]; thyroid cancer: 800 mg to 600 mg, 400 mg, and 200 mg) when resumed; If more than 2 dose reductions are required, therapy will be discontinued.
-Grade 4: Permanently discontinue therapy.
HEMORRHAGE REQUIRING MEDICAL INTERVENTION:
-Grade 2 and above: Permanently discontinue therapy.
HYPERTENSION:
-Grade 2 asymptomatic and diastolic pressure 90 to 99 mm Hg: Treat with hypertensive therapy; continue this drug as scheduled and closely monitor blood pressure.
-Grade 2 (symptomatic/persistent) OR Grade 2 symptomatic increase by greater than 20 mm Hg (diastolic) or greater than 140/90 mm Hg if previously within normal limits OR Grade 3: Interrupt therapy until symptoms resolve and diastolic blood pressure is less than 90 mm Hg. Treat with antihypertensives. Reduce dose one dose level (HCC and RCC: 400 mg daily, 200 mg daily, or 400 every other day]; thyroid cancer: 800 mg to 600 mg, 400 mg, and 200 mg) when resumed; If more than 2 dose reductions are required, therapy will be discontinued.
-Grade 4: Permanently discontinue therapy.
SEVERE DRUG INDUCED LIVER INJURY:
GI PERFORATION:
Any Grade: Permanently discontinue therapy.
QT PROLONGATION:
-Monitor electrolytes and electrocardiograms; if QTc is greater than 500 milliseconds or for an increase from baseline of 60 milliseconds or greater: Interrupt therapy and correct electrolyte abnormalities (e.g., magnesium, potassium, calcium); use medical judgement before restarting therapy.
SEVERE DILI:
-Greater than Grade 3 ALT in the absence of another causes AST/ALT greater than 3 X ULN with bilirubin greater than 2 X ULN in the absence of another cause: Permanently discontinue therapy.
NON-HEMATOLOGICAL TOXICITIES:
-Grade 2: Treat on time. Reduce dose one dose level (HCC and RCC: 400 mg daily, 200 mg daily, or 400 every other day]; thyroid cancer: 800 mg to 600 mg, 400 mg, and 200 mg) when resumed
-Grade 3:
---FIRST OCCURRENCE: Interrupt therapy until Grade 2 or less. Reduce dose one dose level (HCC and RCC: 400 mg daily, 200 mg daily, or 400 every other day]; thyroid cancer: 800 mg to 600 mg, 400 mg, and 200 mg) when resumed.
---IF NO IMPROVEMENT WITHIN 7 DAYS OR SECOND OR THIRD OCCURRENCE: Interrupt therapy until Grade 2 or less. Reduce dose two dose levels (HCC and RCC: 400 mg daily, 200 mg daily, or 400 every other day]; thyroid cancer: 800 mg to 600 mg, 400 mg, and 200 mg) when resumed.
---FOURTH OCCURRENCE: Interrupt therapy until Grade 2 or less. Decrease three dose levels (HCC and RCC: 400 mg daily, 200 mg daily, or 400 every other day]; thyroid cancer: 800 mg to 600 mg, 400 mg, and 200 mg) when resumed.
---Grade 4: Permanently discontinue therapy.

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 Toxicities in Patients with Hepatocellular Carcinoma (HCC) or Renal Cell Carcinoma (RCC):
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 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 second occurrence: 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 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 Differentiated Thyroid Carcinoma (DTC):
-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: Interrupt therapy until toxicity resolves to Grade 1; if therapy is resumed, decrease the dose
-Suggested dose modification for the third occurrence: Reduce dose to 200 mg once daily
-Suggested dose modification for the fourth occurrence: Permanently 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 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

Frequently asked questions

Further information

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