Class: Biological therapy

Generic Name: Regorafenib
Trade Name: Stivarga®

How is this drug used? Stivarga is used to treat patients with metastatic colorectal cancer that has previously been treated with certain types of chemotherapy and other medications.

What is the mechanism of action? Stivarga is a type of drug known as a multi-kinase inhibitor. It blocks several enzymes that play a role in cancer growth.

How is Stivarga given (administered)? 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 andSt. John’sWort while you are taking Stivarga.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician about all medical conditions, including liver problems, bleeding problems, high blood pressure, and heart problems or chest pain.
• Patients should inform their physician about any plans to have surgery.
• Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter).
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Stivarga can harm an unborn baby.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Also tell your doctor if you experience signs of liver problems (such as yellowing of the skin or the whites of the eyes, nausea or vomiting, dark urine, or changes in sleep pattern), signs of bleeding problems (such as 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),  signs of skin problems (such as redness, pain, blisters, bleeding, or swelling on the palms of the hands or soles of the feet, or a rash), signs of severe high blood pressure (such as severe headaches, lightheadedness, or changes in vision), signs of heart problems (such as chest pain, shortness of breath, dizziness, or feeling like you’re going pass out; contact emergency help), signs of Reversible Posterior Leukoencephalopathy Syndrome (such as severe headaches, seizure, confusion, or change in vision), or signs of a tear in the gastrointestinal tract (such as 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.

Copyright © 2016 CancerConnect Last updated 10/12.

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