Medication Guide App

Stivarga Dosage

Generic name: regorafenib
Dosage form: tablet, film coated

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

Recommended Dose

The recommended dose is 160 mg regorafenib (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity.

Take Stivarga at the same time each day. Swallow tablet whole with a low-fat breakfast that contains less than 30% fat [see Clinical Pharmacology (12.3)]. Examples of a low-fat breakfast include 2 slices of white toast with 1 tablespoon of low-fat margarine and 1 tablespoon of jelly, and 8 ounces of skim milk (319 calories and 8.2 g fat); or 1 cup of cereal, 8 ounces of skim milk, 1 slice of toast with jam, apple juice, and 1 cup of coffee or tea (520 calories and 2 g fat). Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.

Dose Modifications

Interrupt Stivarga for the following:

NCI CTCAE Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia (PPE)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR
Symptomatic Grade 2 hypertension
Any NCI CTCAE Grade 3 or 4 adverse reaction

Reduce the dose of Stivarga to 120 mg:

For the first occurrence of Grade 2 HFSR of any duration
After recovery of any Grade 3 or 4 adverse reaction
For Grade 3 aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevation; only resume if the potential benefit outweighs the risk of hepatotoxicity

Reduce the dose of Stivarga to 80 mg:

For re-occurrence of Grade 2 HFSR at the 120 mg dose
After recovery of any Grade 3 or 4 adverse reaction at the 120 mg dose (except hepatotoxicity)

Discontinue Stivarga permanently for the following:

Failure to tolerate 80 mg dose
Any occurrence of AST or ALT more than 20 times the upper limit of normal (ULN)
Any occurrence of AST or ALT more than 3 times ULN with concurrent bilirubin more than 2 times ULN
Re-occurrence of AST or ALT more than 5 times ULN despite dose reduction to 120 mg
For any Grade 4 adverse reaction; only resume if the potential benefit outweighs the risks
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