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Stivarga
Regorafenib
$4825.00
40mg · 84 tablets
BrandBranded medicine· By Bayer
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FDA boxed warningHepatotoxicity
Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.
Monitor hepatic function prior to and during treatment.
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
About Stivarga
Overview
Stivarga (regorafenib) is a prescription cancer medicine supplied as tablets for adults. It treats colorectal cancer that has spread after previous treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF therapy and, if the cancer is RAS wild-type, anti-EGFR therapy. It also treats locally advanced gastrointestinal stromal tumours (GIST), GIST that cannot be removed by surgery or has spread, after imatinib and sunitinib; and hepatocellular carcinoma, a type of liver cancer, after sorafenib. It works by blocking several proteins called kinases involved in cancer growth, the formation of blood vessels supplying tumours and cancer spread.
What it treats
- Colorectal cancer that has spread to other parts of the body in adults previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF therapy and, if the cancer is RAS wild-type, anti-EGFR therapy. - Gastrointestinal stromal tumour (GIST) that is locally advanced, cannot be removed surgically or has spread, in adults previously treated with imatinib mesylate and sunitinib malate. - Hepatocellular carcinoma (HCC), a type of liver cancer, in adults previously treated with sorafenib.
Safety information
Side effects
Common side effects of Stivarga include pain, including stomach or abdominal pain; hand-foot skin reactions; weakness or tiredness; diarrhea; reduced appetite or food intake; high blood pressure; infections; voice changes; increased bilirubin levels in the blood; fever; inflammation of moist body linings, such as inside the mouth; weight loss; rash; and nausea. Serious side effects that warrant prompt medical attention include liver injury, worsening or severe infections, severe or life-threatening bleeding, a hole or abnormal connection in the stomach or intestines, severe or persistent skin reactions, severe or uncontrolled high blood pressure, reduced blood flow to the heart or a heart attack, and a serious brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Contact a doctor promptly if you experience or suspect any of these problems. Liver function needs to be monitored during treatment. Stivarga can also impair wound healing, so tell your doctor about planned surgery or wound-healing problems. It can harm an unborn baby; contact your doctor if pregnancy occurs during treatment.
FDA boxed warning
Hepatotoxicity
Severe and sometimes fatal hepatotoxicity has occurred in clinical trials.
Monitor hepatic function prior to and during treatment.
Interrupt and then reduce or discontinue STIVARGA for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Stivarga can harm an unborn baby. Women who could become pregnant should use effective contraception during treatment and for 2 months after the final dose. Men should use effective contraception for 2 months after the final dose. Breastfeeding or Stivarga treatment should be stopped, taking into account the importance of treatment to the mother. Stivarga requires caution because of risks of liver injury, infections, bleeding, a hole or abnormal connection in the stomach or bowel, skin reactions, high blood pressure, reduced blood flow to the heart or heart attack, and a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Liver function tests must be monitored. These complications may require treatment to be paused, adjusted or stopped by the prescriber. Severe or life-threatening bleeding, gastrointestinal perforation or fistula, and RPLS require treatment to be stopped. Stivarga may impair wound healing. Tell the treating team about any planned surgery. Treatment must be withheld before elective surgery and after major surgery until adequate healing has occurred. The safety of restarting treatment after wound-healing complications has not been established.
Interactions
Avoid taking Stivarga with medicines that strongly increase or block the activity of an enzyme called CYP3A4 (strong CYP3A4 inducers or inhibitors). Stivarga may increase exposure to medicines known as BCRP substrates. If you take one of these medicines, your doctor should monitor you closely for symptoms of increased exposure. Ask your doctor to check whether any of your medicines fall into these groups.
Using Stivarga
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label STIVARGA (REGORAFENIB) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] (DailyMed, retrieved 19 September 2026).
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