Stivarga

Pronunciation

Generic Name: regorafenib (RE goe RAF e nib)
Brand Names: Stivarga

What is Stivarga?

Stivarga (regorafenib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Stivarga is used to treat colorectal cancer. It is also used to treat a rare type of tumor that can affect the esophagus, stomach, or intestines.

Regorafenib is usually given after other cancer medications have been tried without success.

Stivarga may also be used for purposes not listed in this medication guide.

Important information

You should not use Stivarga if past use has caused severe bleeding, or if you have severe liver disease.

Stivarga can harm your liver. Stop taking this medicine and call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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Stivarga can also cause severe bleeding. Call your doctor if you have blood in your urine or stools, abnormal vaginal bleeding, coughing up blood, or any bleeding that will not stop.

Before taking this medicine

You should not use Stivarga if past use has caused severe bleeding, or if you have severe liver disease.

To make sure Stivarga is safe for you, tell your doctor if you have:

  • liver disease;

  • heart disease, high blood pressure;

  • bleeding or blood clotting disorder such as hemophilia;

  • a history of recent heart attack or stroke (including "mini-stroke"); or

  • if you have recently had surgery.

FDA pregnancy category D. Do not use Stivarga if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Use birth control to prevent pregnancy while you are receiving Stivarga, whether you are a man or a woman. Tell your doctor right away if a pregnancy occurs while either parent is taking Stivarga. Keep using birth control for at least 2 weeks after your treatment ends.

It is not known whether regorafenib passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Stivarga?

Take Stivarga exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Stivarga is usually taken daily for 3 weeks followed by 1 week off the medicine. Your doctor will determine how many times you should repeat this treatment cycle.

Stivarga works best if you take it with a low-fat breakfast.

Do not crush, chew, or break the tablet. Swallow the tablet whole.

While using Stivarga, your blood pressure will need to be checked often. You may also need frequent blood tests at your doctor's office.

If you need surgery, tell the surgeon ahead of time that you are using Stivarga. You may need to stop using the medicine at least 2 weeks before your surgery. Follow your doctor's instructions.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Throw away any Stivarga tablets not used within 28 days after opening the bottle.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Grapefruit and grapefruit juice may interact with Stivarga and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking this medicine.

Stivarga side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Stivarga: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Stivarga and call your doctor at once if you have:

  • fever, chills, flu symptoms, mouth sores, severe or ongoing vomiting or diarrhea;

  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • blood in your urine or stools, coughing up blood or vomit that looks like coffee grounds;

  • heavy menstrual periods or abnormal vaginal bleeding;

  • any bleeding that will not stop;

  • chest pain and severe dizziness, fainting, feeling short of breath;

  • headache, confusion, change in mental status, vision loss, seizure (convulsions);

  • upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • dangerously high blood pressure (blurred vision, buzzing in your ears, anxiety, uneven heartbeats);

  • rash, blisters, oozing, or severe pain in the palms of your hands or the soles of your feet;

  • any wound that won't heal; or

  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Stivarga side effects may include:

  • diarrhea, stomach pain, weight loss;

  • hoarse voice; or

  • feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Stivarga?

Many drugs can interact with Stivarga. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Stivarga, especially:

  • bosentan;

  • imatinib;

  • nefazodone;

  • St. John's wort;

  • an antibiotic--clarithromycin, nafcillin, rifabutin, rifampin, rifapentine, telithromycin;

  • antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

  • heart medication--nicardipine, quinidine;

  • hepatitis C medications--boceprevir, telaprevir;

  • HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir; or

  • seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone.

This list is not complete and many other drugs can interact with Stivarga. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Stivarga.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Stivarga only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 1.01. Revision Date: 2013-03-14, 6:49:14 PM.

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