Sorafenib Dosage

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Renal Cell Carcinoma

400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Usual Adult Dose for Thyroid Cancer

400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Usual Adult Dose for Hepatocellular Carcinoma

400 mg twice a day at least one hour before or two hours after eating

Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Child-Pugh A and B hepatic impairment: No adjustment recommended.

Child-Pugh C hepatic impairment: Data not available.

Dose Adjustments

Temporary interruption is recommended in patients undergoing major surgical procedures

Temporary interruption or permanent discontinuation may be required for the following:
Cardiac ischemia or infarction; hemorrhage requiring medical intervention; severe or persistent hypertension despite adequate anti-hypertensive therapy; gastrointestinal 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

The suggested dose modifications for skin toxicity for patients with HCC or RCC are as follows:

Skin Toxicity Grade 1 - Numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema, or discomfort of the hands or feet which does not disrupt the patients normal activities.
Suggested Dose Modification For Any Occurrence:
-Continue treatment with sorafenib and consider topical therapy for symptomatic relief.

Skin Toxicity Grade 2 - Painful erythema and swelling of the hands or feet and/or discomfort affecting the patients normal activities.
Suggested Dose Modification For The First Occurrence:
-Continue treatment with sorafenib and consider topical therapy for symptomatic relief.
Suggested Dose Modification For The Second or Third Occurrence Or If There Is No Improvement Within Seven Days:
-Interrupt treatment until toxicity resolves to Grade 0 to 1.
-When resuming treatment, decrease the dose of sorafenib by one dose level (to 400 mg once daily or 400 mg once every other day).
Suggested Dose Modification For The Fourth Occurrence:
-Discontinue treatment with sorafenib.

Skin Toxicity Grade 3 - Moist desquamation, ulceration, blistering, or severe pain of the hands or feet, or severe discomfort that causes the patient to be unable to work or perform activities of daily living.
Suggested Dose Modification For The First Or Second Occurrence:
-Interrupt treatment until toxicity resolves to Grade 0 to 1.
-When resuming treatment, decrease the dose of sorafenib by one dose level (to 400 mg once daily or 400 mg once every other day).
Suggested Dose Modification For The Third Occurrence:
-Discontinue treatment with sorafenib.

Dose modifications for Differentiated Thyroid Carcinoma (DTC):
First Dose Reduction: 600 mg total daily dose (400 mg and 200 mg 12 hours apart)
Second Dose Reduction: 200 mg twice daily
Third Dose Reduction: 200 mg once daily.

The suggested dose modifications for skin toxicity in patients with DTC are as follows:

Skin Toxicity Grade 1:
Suggested Dose Modification For Any Occurrence:
-Continue treatment with sorafenib.

Skin Toxicity Grade 2:
Suggested Dose Modification For The First Occurrence:
-Decrease sorafenib dose to 600 mg daily. If no improvement within 7 days, see below.
Suggested Dose Modification For The Second or Third Occurrence Or If There Is No Improvement Within Seven Days:
-Interrupt treatment until toxicity resolves to Grade 1.
-When resuming treatment, decrease the dose according to dose modification guidelines.
Suggested Dose Modification For The Fourth Occurrence:
-Discontinue treatment with sorafenib.

Skin Toxicity Grade 3:
Suggested Dose Modification For The First Occurrence:
-Interrupt treatment until toxicity resolves to Grade 1.
-When resuming treatment, decrease the dose of sorafenib by one dose level.
Suggested Dose Modification For The Second Occurrence:
-Interrupt treatment until toxicity resolves to Grade 1.
-When resuming treatment, decrease the dose of sorafenib by one dose level.
Suggested Dose Modification For The Third Occurrence:
-Discontinue sorafenib permanently.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

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