INDICATIONS AND USAGE（适应症）

Colorectal Cancer

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 wild- type, 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.

Hepatocellular Carcinoma

STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

DOSAGE（服用剂量）

Recommended Dose

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. Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day.

ADVERSE REACTIONS（不良反应）

The following serious adverse reactions are discussed elsewhere in the labeling:

Hepatotoxicity

Infections

Hemorrhage

Gastrointestinal Perforation or Fistula

Dermatological Toxicity

Hypertension

Cardiac Ischemia and Infarction

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/824f19c9-0546-4a8a-8d8f-c4055c04f7c7/spl-doc?hl=Regorafenib

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