Sunitinib

Sunitinib

(su NIT e nib)

Sutent

Very bad and sometimes deadly liver problems have happened with this drug. 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.

It is used to treat cancer.

If you have an allergy to sunitinib or any other part of this drug. If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had. If you are pregnant or may be pregnant. This drug may cause harm to an unborn baby. Women must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away. If you are breast-feeding. Do not breast-feed while you take this drug or for 1 month after you stop this drug. This is not a list of all drugs or health problems that interact with this drug. 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 drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this drug. 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 have happened with this drug. Talk with the doctor. This drug 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. Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit. Very bad and sometimes deadly heart problems like heart failure and heart attack have happened with this drug. 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. Very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) and tissue damage (necrotizing fasciitis) have happened with this drug. 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. Very bad and sometimes deadly blood problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with this drug 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. If you are 65 or older, use this drug with care. You could have more side effects. This drug may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child. This drug may cause harm to an unborn baby. A pregnancy test will be done before you start this drug to show that you are NOT pregnant. Men with a partner who may get pregnant must use birth control while taking this drug and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding 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 change in weight; feeling nervous, excitable, restless, or weak; hair thinning; depression; neck swelling; not able to focus; trouble with heat or cold; menstrual changes; shakiness; or sweating. Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up. Jaw pain. Redness or irritation of the palms of hands or soles of feet. Low mood (depression). Dizziness or passing out. Headache. Flu-like signs. Patients with cancer who take this drug may be at a greater risk of getting a severe health problem called tumor lysis syndrome (TLS). This may lead to death. Call your doctor right away if you have a fast or abnormal heartbeat; any passing out; trouble passing urine; muscle weakness or cramps; upset stomach, throwing up, diarrhea, or not able to eat; or feel sluggish.

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: Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry. Feeling tired or weak. Weight loss. Skin or hair that is lighter in color. Hair loss. Dry skin. Itching. Trouble sleeping. Change in taste. Mouth irritation or mouth sores. Dry mouth. Gas. Back, muscle, or joint 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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with or without food. Keep taking this drug 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 drug. This includes your doctors, nurses, pharmacists, and dentists. Avoid grapefruit and grapefruit juice. If you have upset stomach, throwing up, 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 this drug and while taking it. This includes an ECG. 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. Check your blood pressure as you have been told. This drug may affect how wounds heal. If you need to have surgery, you may need to stop this drug before surgery. Start taking it again after surgery as you have been told by your doctor. Call your doctor right away if you have a wound that does not heal or any other wound problems. Severe jaw problems have happened. Have a dental exam before you start this drug. Take good care of your teeth. High protein levels in the urine and kidney problems have happened. Sometimes, these have been deadly. Have your urine checked while taking this drug as you are told. You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor. Rarely, some bleeding problems have been deadly.

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.

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. Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

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. This drug comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this drug is refilled. If you have any questions about this drug, 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 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 this medicine. 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 this medicine.