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Regorafenib is available as a 40 mg oral tablet.

Regorafenib is a kinase inhibitor indicated for the treatment of patients with:

• Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an antiVEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.
• Locally advanced, unresectable or metastatic gastrointestinal stromal tumor
  (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.
• Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Regorafenib works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

The recommended dose of Regorafenib is 160 mg orally, once daily for the first 21 days of each 28-day cycle after a low-fat meal.

Regorafenib is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Regorafenib:

• Pain (including gastrointestinal and abdominal pain)
• Asthenia/fatigue
• Diarrhea
• Decreased appetite/food intake
• Hypertension
• Infection
• Fever
• Weight loss
• Rash
• Nausea

Serious side effects are rare with Regorafenib. Contact your doctor if you experience any of the following.

• Infections
• Severe bleeding
• Severe skin rash
• Tear in your stomach
• Heart attack
• Wound healing problems

The following medications may interact with Regorafenib:

• Strong CYP3A4 inducers: Avoid strong CYP3A4 inducers
• Strong CYP3A4 inhibitors: Avoid strong CYP3A4 inhibitors
• BCRP substrates: Monitor patients closely for symptoms of increased exposure to BCRP substrates

Various FDA-approved generic manufacturers

Regorafenib can harm your unborn baby. Females should use effective birth control during treatment with Regorafenib and for 2 months after your final dose of Regorafenib. Tell your healthcare provider right away if you become pregnant during treatment with Regorafenib or within 2 months after your final dose of Regorafenib. Males with female partners who can become pregnant should use effective birth control during treatment with Regorafenib and for 2 months after your final dose of Regorafenib.

• Stivarga