IMPORTANT SAFETY INFORMATION: STIVARGA can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests... Continue reading below
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Benefits of STIVARGA® (regorafenib)

You may have tried several therapies as part of your treatment plan. If you have failed those treatments, STIVARGA may be appropriate for you.

STIVARGA is a once-daily, prescription anticancer medicine that you can take at home and has been shown to help previously treated patients with metastatic colorectal cancer live longer versus placebo and prevent the cancer from progressing. Stivarga has also been shown to help previously treated GIST patients prevent the cancer from progressing.

In the clinical trial of patients with metastatic CRC (mCRC), STIVARGA increased overall survival—or the length of time when patients were enrolled into the study to death from any cause versus placebo.

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In the GIST trial, there was no significant difference in overall survival between patients taking STIVARGA and those on placebo based on the 29% of all events for the final trial analysis.

In clinical trials of patients with CRC or GIST, STIVARGA was shown to increase an endpoint called “progression-free survival”—or the length of time during treatment that a patient lives with cancer but it does not get worse.

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The 505 patients taking STIVARGA experienced a median PFS of 2 months compared to 1.7 months for those taking placebo. That means those on STIVARGA had a 51% reduction in the risk of disease progression compared to placebo. 417 of 505 STIVARGA patients (83%) vs 231 of 255 placebo patients (91%) progressed or died.

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The 133 patients taking STIVARGA experienced a median PFS of 4.8 months compared to 0.9 months of those taking placebo (66 patients). That means those on STIVARGA had a 73% reduction in the risk of disease progression compared to placebo. 82 of 133 STIVARGA patients (62%) vs 63 of 66 placebo patients (96%) experienced disease progression or died.

STIVARGA is an anticancer medicine

STIVARGA is a once-daily, oral prescription anticancer medicine approved by the FDA for people with:

It is not known if STIVARGA is safe and effective in children less than 18 years of age

If previous anticancer treatments have not worked fully, or if your cancer has spread, STIVARGA may help.

If you have CRC...
You may have already tried certain chemotherapy
If your CRC has spread to other parts of your body, STIVARGA may be an option for you
If you have GIST...
Previous treatment may have involved surgery and medicines to target the cells involved in GIST
If your GIST has spread to other parts of your body after previous treatment and cannot be treated with surgery, STIVARGA may help

How might STIVARGA work differently as a multikinase inhibitor?

STIVARGA is a systemic therapy that works throughout your body to help fight mCRC or GIST. STIVARGA, a multikinase inhibitor, may work by blocking some proteins on certain cancer cells that tell the cancer to grow. In this way, STIVARGA may stop cancer from growing for a period of time.

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  • Cancer involves the uncontrolled growth of certain cells in the body
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  • STIVARGA may hinder the signals that tell cancer cells to multiply, and may slow the growth of tissue that connects cancer cells
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  • STIVARGA may also stop the creation of new blood vessels that feed cancer cells
Colorectal cancer (CRC)
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Gastrointestinal stromal tumor (GIST)
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CRC: What you need to know

CRC is a kind of cancer that starts in the lower part of the digestive system. CRC may spread throughout the body. If this happens, it is called metastatic colorectal cancer (mCRC) because the cancer has metastasized, or spread, to other areas.

CRC is one of the most common forms of cancer for both men and women in the United States. It develops most often in people over 50.

Indications

STIVARGA® (regorafenib) is a prescription medicine used to treat people with:

It is not known if STIVARGA is safe and effective in children less than 18 years of age.

Important Safety Information

STIVARGA (regorafenib) can cause liver problems, which can be serious and sometimes lead to death. Your healthcare provider will do blood tests to check your liver function before you start taking STIVARGA and during your treatment with STIVARGA to check for liver problems. Tell your healthcare provider right away if you experience yellowing of your skin or the white part of your eyes, nausea, vomiting, dark urine, or change in your sleep pattern.

Before taking STIVARGA, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Avoid drinking grapefruit juice and taking St. John’s Wort while taking STIVARGA.

STIVARGA may cause serious side effects, including:

The most common side effects with STIVARGA include pain including stomach-area (abdomen); tiredness, weakness, fatigue; diarrhea (frequent or loose bowel movements); decreased appetite; infection; voice change or hoarseness; increase in certain liver function tests; fever; swelling, pain, and redness of the lining in your mouth, throat, stomach, and bowel (mucositis); and weight loss

For important risk and use information about STIVARGA, please see the full Prescribing Information, including Boxed Warning.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.