Generic name: REGORAFENIB MONOHYDRATE 40mg
Dosage form: tablet, film coated
Medically reviewed on April 27, 2017.
The recommended dose is 160 mg STIVARGA (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 water after a low-fat meal that contains less than 600 calories and less than 30% fat [see Clinical Pharmacology (12.3)]. Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day.
If dose modifications are required, reduce the dose in 40 mg (one tablet) increments; the lowest recommended daily dose of STIVARGA is 80 mg daily.
Interrupt STIVARGA for the following:
- Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia syndrome (PPES)] 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 Grade 3 or 4 adverse reaction
- Worsening infection of any grade
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 except infection
- 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 or infection)
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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: multikinase inhibitors