Rarely, sunitinib has caused severe (sometimes fatal) liver problems. Get medical help right away if you develop symptoms of liver problems such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, pale stools, or yellowing eyes/skin. Your doctor will monitor for liver problems with blood tests. Tell all of your doctors and pharmacists if you have ever stopped taking sunitinib because of liver problems (including high liver enzymes).Who should not take sunitinib?
This medication is used to treat certain types of cancer (kidney, pancreas, and intestinal). Sunitinib works by stopping or slowing the growth of cancer tumors. It also works by slowing the growth of new blood vessels within the tumor.
Read the Medication Guide provided by your pharmacist before you start taking sunitinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, with or without food, usually once daily.
Drink plenty of fluids during treatment with this medication, unless otherwise directed by your doctor.
The dosage is based on your medical condition and response to treatment. For some conditions, you may be directed to take this medication for a specific period of time followed by another period of time off of the drug. For other conditions, you may be directed to take sunitinib every day without a break. Follow your doctor's instructions.
Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.
See also Warning section.
Upset stomach, nausea, vomiting, diarrhea, change in taste, decreased appetite, dry/cracked/thickened skin, watering eyes, swelling around eyes, numbness/tingling of arms/legs, or tiredness may occur. In some cases, drug therapy may be necessary to prevent or relieve nausea/vomiting/diarrhea. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, notify your doctor or pharmacist promptly.
This medication may cause patchy or complete hair loss and changes in hair/skin color. These effects are not harmful. However, talk to your doctor for more details since changes in skin color may also be a sign of a more serious condition.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: headache, rash/blisters on palms of hands/soles of feet, sores/pain on the tongue/mouth, easy bruising/bleeding, swelling ankles/feet, shortness of breath, unusual weight changes, cold/heat intolerance, pain/redness/swelling of arms or legs, unusual tiredness, black/bloody stools, vomit that looks like coffee grounds, coughing up blood, slow wound healing, jaw pain, toe/joint/back pain, painful urination, cloudy/pink/bloody urine, change in the amount of urine, muscle weakness/cramping/twitching, mental/mood changes (such as decreased alertness), vision changes (such as decreased vision).
Sunitinib has rarely caused very serious (possibly fatal) skin reactions. Get medical help right away if you develop symptoms of serious skin reactions, including: rash, hot/peeling/blistering/painful skin, red/purple skin.
This medication can lower the body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills or persistent sore throat.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking sunitinib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, heart problems (e.g., congestive heart failure), high blood pressure, liver problems, thyroid disease.
Sunitinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sunitinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sunitinib safely.
To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports.
Wash your hands well to prevent the spread of infections.
Infrequently, people taking sunitinib have had serious jawbone problems (osteonecrosis). Poor dental hygiene, poorly fitting dentures, having certain dental work (such as tooth removal, dental surgery), or also taking bisphosphonate drugs (such as alendronate) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.
Before having surgery (including dental procedures), tell your doctor or dentist about this medication and all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
This drug is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. To avoid pregnancy, both males and females using the drug must use reliable form(s) of birth control during treatment.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: bevacizumab, "blood thinners" (anticoagulants such as warfarin, heparins).
Many drugs besides sunitinib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using sunitinib, report all medications you are currently using to your doctor or pharmacist.
Other medications can affect the removal of sunitinib from your body, which may affect how sunitinib works. Examples include azole antifungals (such as ketoconazole, itraconazole), cimetidine, HIV protease inhibitors (such as ritonavir, saquinavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin, rifabutin), St. John's wort, certain drugs used to treat seizures (such as carbamazepine, phenytoin, phenobarbital), among others.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as blood pressure, complete blood count, heart/liver/kidney/thyroid function tests, uric acid level, pancreatic enzymes, urine protein levels, blood mineral levels such as sodium, potassium, phosphate) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised July 2014. Copyright(c) 2014 First Databank, Inc.
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