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Sutent

Generic Name: Sunitinib (su NIT e nib)
Brand Name: Sutent

Warning

  • Very bad and sometimes deadly liver problems have happened with Sutent (sunitinib). You will need to have your liver checked while you take this drug. 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.

Uses of Sutent:

  • It is used to treat cancer of the GI (gastrointestinal) tract.
  • It is used to treat kidney cancer.
  • It is used to treat pancreatic 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 Sutent?

  • If you have an allergy to sunitinib 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 are taking St. John's wort. Do not take St. John's wort with Sutent. This medicine may not work as well.
  • If you are breast-feeding. Do not breast-feed while you take this medicine or for 1 month after you stop Sutent.

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

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 Sutent 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 Sutent?

  • 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.
  • Holes in the GI (gastrointestinal) tract may rarely happen.
  • Very bad and sometimes deadly bleeding problems have happened with Sutent. Talk with the doctor.
  • This medicine may lower blood sugar levels. This may lead to passing out or the need to go to the hospital. Call your doctor right away if you have signs of low blood sugar like anxiety, sweating, feeling weak, dizziness, feeling sleepy, fast heartbeat, change in eyesight, headache, chills, shakiness, confusion, or hunger.
  • Very bad and sometimes deadly heart problems like heart failure and heart attack have happened with this medicine. Call your doctor right away if you have a heartbeat that does not feel normal, chest pain or pressure, shortness of breath, a big weight gain, or swelling in the arms or legs.
  • This medicine may cause a bad and sometimes deadly health problem called tumor lysis syndrome (TLS). Call your doctor right away if you have a fast heartbeat or a heartbeat that does not feel normal; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, loose stools or not able to eat; or feel sluggish.
  • Very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) and tissue damage (necrotizing fasciitis) have happened with Sutent. Sometimes, these have been deadly. Get medical help right away if you have a rash; red, swollen, blistered, or peeling skin (with or without fever); warm skin with red or purple areas of swelling that spread quickly; or any other skin changes that concern you. Get medical help if you have black spots on your skin; red or irritated eyes; or sores or ulcers in your mouth, throat, nose, or eyes.
  • If you are 65 or older, use this medicine 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.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant.
  • If you are able to get pregnant, a pregnancy test will be done to show that you are NOT pregnant before starting Sutent. Talk with your doctor.
  • Use birth control that you can trust to prevent pregnancy while taking this medicine and for 1 month after stopping Sutent (sunitinib).
  • If you get pregnant while taking this medicine or within 1 month after your last dose, call your doctor right away.
  • If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during care and for 7 weeks after care ends. Use birth control that you can trust. If your sex partner gets pregnant while you take Sutent or within 7 weeks after your last dose, call your doctor right away.

How is this medicine (Sutent) best taken?

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

  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking Sutent as you have been told by your doctor or other health care provider, even if you feel well.
  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid grapefruit and grapefruit juice.
  • 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.
  • You may need to have your heart checked before starting Sutent and while taking it. This includes an ECG. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Check your blood sugar as you have been told by your doctor.
  • High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
  • This medicine may affect how wounds heal. If you need to have surgery, you may need to stop Sutent before surgery. Start taking it again after surgery as you have been told by your doctor. Talk with your doctor.
  • Very bad jaw problems have happened with this medicine. Have a dental exam before you start Sutent. Take good care of your teeth. Talk with your doctor.
  • High protein levels in the urine and kidney problems have happened with this medicine. Sometimes, these have been deadly. You will need to have your urine checked while taking Sutent. Talk with the doctor.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

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 kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of thyroid problems like a change in weight without trying, feeling nervous and excitable, feeling restless, feeling very weak, hair thinning, low mood (depression), neck swelling, not able to focus, not able to handle heat or cold, period (menstrual) changes, shakiness, or sweating.
  • Jaw pain.
  • Redness or irritation of the palms of hands or soles of feet.
  • Low mood (depression).
  • Dizziness or passing out.
  • Change in eyesight.
  • Headache.
  • Very bad and sometimes deadly blood problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with this medicine in some people. Call your doctor right away if you feel very tired or weak or have any bruising or bleeding; dark urine or yellow skin or eyes; pale skin; change in the amount of urine passed; change in eyesight; change in strength on 1 side is greater than the other, trouble speaking or thinking, or change in balance; or fever.

What are some other side effects of Sutent?

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:

  • Feeling tired or weak.
  • Upset stomach or throwing up.
  • Not hungry.
  • Weight loss.
  • Loose stools (diarrhea).
  • Hard stools (constipation).
  • Change in color of hair.
  • Hair loss.
  • Dry skin.
  • Itching.
  • Not able to sleep.
  • Change in taste.
  • Mouth irritation or mouth sores.
  • Dry mouth.
  • Gas.
  • Muscle or joint pain.
  • Back pain.
  • Nose or throat irritation.

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 Sutent?

  • Store at room temperature.
  • 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.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Sutent (sunitinib) is refilled. If you have any questions about this medicine, please talk with the doctor, 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 Sutent 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 this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Sutent. 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 this medicine.

Review Date: December 6, 2017

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