Sorafenib Dosage

This dosage information may not include all the information needed to use Sorafenib safely and effectively. See additional information for Sorafenib.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Renal Cell Carcinoma

Initial dose: 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

Initial dose: 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

Management of suspected adverse reactions may require temporary interruption and/or dose reduction of sorafenib therapy. When dose reduction is necessary, the dose may be reduced to 400 mg once daily. If additional dose reduction is required, sorafenib may be reduced to a single dose every other day.

The suggested dose modifications for skin toxicity 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.

Precautions

In one study, the incidence of treatment-emergent cardiac ischemia/infarction events was higher in sorafenib treated patients compared to placebo. Temporary or permanent discontinuation of sorafenib should be considered in patients who develop cardiac ischemia and/or infarction.

An increased risk of bleeding may occur following administration of sorafenib. If any bleeding event necessitates medical intervention, permanent discontinuation of sorafenib should be considered.

Treatment-emergent hypertension has been reported in patients treated with sorafenib. The hypertension was usually mild to moderate. Blood pressure should be monitored weekly during the first six weeks of sorafenib therapy. From that time on, it should be monitored and treated as needed, in accordance with standard medical practice. For cases of severe or persistent hypertension (despite starting antihypertensive therapy) temporary or permanent discontinuation or sorafenib should be considered.

Hand-foot skin reaction and rash have been the most common side effects caused by sorafenib. Rash and hand-foot skin reaction are usually common terminology criteria for adverse events (CTCAE) Grade 1 and 2 and generally appear during the first six weeks of treatment. Management of dermatologic toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification of sorafenib.

Sorafenib should be discontinued in the rare event of a gastrointestinal perforation.

Temporary interruption of sorafenib therapy is recommended in patients undergoing major surgical procedures. There is limited clinical experience regarding the timing of reinitiation of sorafenib therapy following major surgical intervention. Therefore, the decision to resume sorafenib therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing.

Sorafenib can prolong the QT/QTc interval. QT/QTc interval prolongation increases the risk for ventricular arrhythmias. Avoid sorafenib in patients with congenital long QT syndrome. Use caution and carefully monitor patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities.

Bleeding or elevations in the International Normalized Ratio (INR) have been reported in patients taking warfarin while on sorafenib. Monitor for changes in prothrombin time (PT), INR or clinical bleeding episodes in patients taking warfarin concomitantly.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

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