Sorafenib Dosage

Medically reviewed by Drugs.com. Last updated on Mar 14, 2024.

Applies to the following strengths: 200 mg

Usual Adult Dose for:

Renal Cell Carcinoma
Thyroid Cancer
Hepatocellular Carcinoma

Additional dosage information:

Renal Dose Adjustments
Liver Dose Adjustments
Dose Adjustments
Precautions
Dialysis

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.