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Stivarga

Generic Name: Regorafenib (re goe RAF e nib)
Brand Name: Stivarga

  • Very bad and sometimes deadly liver problems have happened with Stivarga (regorafenib). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.

Uses of Stivarga:

  • It is used to treat colorectal cancer.
  • It is used to treat cancer of the GI (gastrointestinal) tract.
  • It is used to treat liver cancer.
  • It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Stivarga?

  • If you have an allergy to regorafenib or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease.
  • If you have high blood pressure.
  • If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Stivarga, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this medicine.
  • If you are taking St. John's wort. Do not take St. John's wort with Stivarga. This medicine may not work as well.
  • If you are breast-feeding. Do not breast-feed while you take this medicine and for 2 weeks after your last dose.

This is not a list of all drugs or health problems that interact with Stivarga.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Stivarga?

  • Tell all of your health care providers that you take Stivarga. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid grapefruit and grapefruit juice.
  • High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
  • You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • Very bad and sometimes deadly bleeding problems have happened with Stivarga. Talk with the doctor.
  • A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this medicine. Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
  • Very bad and sometimes deadly holes in the GI (gastrointestinal) tract or fistulas have happened with Stivarga. Talk with the doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • This medicine may affect how wounds heal. If you need to have surgery, you may need to stop this medicine before surgery. Start taking it again after surgery as you have been told by your doctor. Talk with your doctor.
  • If you have upset stomach, throwing up, loose stools (diarrhea), or are not hungry, talk with your doctor. There may be ways to lower these side effects.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with Stivarga (regorafenib).
  • If you are of Asian descent, use this medicine with care. You could have more side effects.
  • If you are 65 or older, use Stivarga with care. You could have more side effects.
  • This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. Talk with the doctor.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 2 months after stopping this medicine. Use birth control that you can trust.
  • If you are a man and your sex partner gets pregnant while you take Stivarga or within 2 months after your last dose, call your doctor right away.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • Use birth control that you can trust during care and for 2 months after care ends.
  • If you get pregnant while taking this medicine or within 2 months after your last dose, call your doctor right away.

How is this medicine (Stivarga) best taken?

Use Stivarga as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take this medicine by mouth with water after a low-fat meal. The low-fat meal must be less than 600 calories and less than 30% fat.
  • Take Stivarga at the same time of day.
  • Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it on the same day you missed the dose.
  • If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
  • Do not take 2 doses on the same day.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Redness or irritation of the palms of hands or soles of feet.
  • Upset stomach or throwing up.
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Swelling of belly.
  • Very loose stools (diarrhea).
  • The chance of decreased blood flow to the heart and heart attack may be raised with this medicine. Call your doctor right away if you have chest pain, dizziness, shortness of breath, or feel like passing out.

What are some other side effects of Stivarga?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Headache.
  • Weight loss.
  • Not hungry.
  • Mouth irritation.
  • Change in voice.
  • Hair loss.
  • Belly pain.
  • Muscle spasm.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Stivarga?

  • Store tablets in the original container at room temperature. Keep the cap tightly closed.
  • Throw away any part not used 7 weeks after opening the bottle.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Stivarga, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Stivarga. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Stivarga (regorafenib).

Review Date: November 1, 2017

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