"The U.S. Food and Drug Administration today expanded the approved use of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved t"...
Stivarga® is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wildtype, an anti-EGFR therapy.
Gastrointestinal Stromal Tumors
Stivarga is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
DOSAGE AND ADMINISTRATION
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]. Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.
Interrupt Stivarga for the following:
- 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 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
Dosage Forms And Strengths
Stivarga is a 40 mg, light pink, oval-shaped, film-coated tablet, debossed with â€˜BAYERâ€™ on one side and â€˜40â€™ on the other side.
Tablets are supplied in packages containing three bottles, with each bottle containing 28 tablets, for a total of 84 tablets per package (NDC 50419-171-03).
Storage And Handling
Store Stivarga at 25°C (77°F); excursions are permitted from 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Store tablets in the original bottle and do not remove the desiccant. Keep the bottle tightly closed after first opening.
Discard any unused tablets 7 weeks after opening the bottle. Dispose of unused tablets in accordance with local requirements.
Manufactured for:Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981 USA. Revised: June /2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 6/28/2016
Additional Stivarga Information
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