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Class: Biological Therapy

Generic Name: regorafenib

Trade Name: Stivarga®

How is Stivarga® used? Stivarga is used to treat patients with metastatic colorectal cancer that has previously been treated with certain types of chemotherapy and other medications. Stivarga is also used for a rare cancer called a GIST (gastrointestinal stomach tumor) that cannot be treated with surgery or that has spread to other parts of the body and for which they have received previous treatment with certain medicines. And Stivarga is used for patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar® (sorafenib).

What is the mechanism of action? Stivarga is a type of drug known as a multi-kinase inhibitor. This drug work by blocking the action of enzymes called kinases, which are involved in many cell functions, including cell signaling, growth, and division. These enzymes may be too active or found at high levels in some types of cancer cells, and blocking them may help keep cancer cells from growing.

How is Stivarga given? Stivarga comes in tablet form and is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Stivarga. Blood will be drawn to monitor functions of some organ systems, such as the liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

What are the most common side effects of treatment with Stivarga?

  • Fatigue
  • Decreased appetite
  • Hand-foot skin reaction
  • Diarrhea
  • Mouth sores (mucositis)
  • Weight loss
  • Infection
  • High blood pressure
  • Changes in hearing
  • Voice changes

What are some of the potentially serious side effects of treatment with Stivarga?

  • Liver problems
  • Bleeding problems
  • Skin problems
  • Severe high blood pressure
  • Heart problems
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
  • A tear in the stomach or the wall of the intestine
  • Problems with wound healing

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Maintain adequate rest and nutrition.
  • Avoid grapefruit juice and St. John’s Wort while you are taking Stivarga.
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What should you tell your healthcare provider before starting treatment with Stivarga?

Tell your healthcare provider if you:

  • Have liver problems.
  • have bleeding problems.
  • Have high blood pressure.
  • Have heart problems or chest pain.
  • Have plans to have surgery.
  • Are pregnant or plan to become pregnant. Stivarga can harm an unborn baby.
  • Are breastfeeding or plan to breastfeed.

Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Stivarga and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.

When should patients notify their physician?

Contact your healthcare professional immediately in case of any of the following:

  • You have symptoms of lung problems. These include: yellowing of the skin or the whites of the eyes, nausea or vomiting, dark urine, or changes in sleep pattern.
  • You have symptoms of bleeding problems. These include: vomiting blood, vomit that looks like coffee grounds, pink or brown urine, red or tarry stools, coughing up blood or blood clots, heavier-than-usual menstrual bleeding, unusual vaginal bleeds, or frequent nose bleeds.
  • You have symptoms of skin problems. These include: redness, pain, blisters, bleeding, or swelling on the palms of the hands or soles of the feet, or a rash.
  • You have symptoms of severe high blood pressure. These include: severe headaches, lightheadedness, or changes in vision.
  • You have symptoms of heart problems. These include: chest pain, shortness of breath, dizziness, or feeling like you’re going pass out. Contact emergency help.
  • You have symptoms of Reversible Posterior Leukoencephalopathy Syndrome. These include: severe headaches, seizure, confusion, or change in vision.
  • You have symptoms of a gastrointestinal tear. These include: severe pain in the abdomen, swelling in the abdomen, or a high fever.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.