Sutent

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.

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 with or without food, usually once daily for 4 weeks followed by 2 weeks off, or as directed by your doctor. The dosage is based on your medical condition and response to therapy. 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.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. 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. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: bevacizumab, "blood thinners" (anticoagulants such as warfarin, heparins), drugs affecting liver enzymes that remove sunitinib from your body (e.g., 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 anti-seizure drugs such as carbamazepine/phenytoin/phenobarbital). This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., blood pressure, complete blood count, certain heart function tests such as LVEF, LFTs, pancreatic enzymes, sodium/potassium/phosphate levels) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

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 require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using sunitinib, tell your doctor or pharmacist 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. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. 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. If you need to have surgery, tell your doctor or dentist that you are using this medication. Wash your hands well to prevent the spread of infections. 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.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

See also Warning section. Upset stomach, nausea, vomiting, diarrhea, change in taste, 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. 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 immediately if any of these unlikely but serious side effects occur: 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, seizures, unusual weight gain, cold intolerance, pain/redness/swelling of arms or legs, unusual tiredness, black/bloody stools, vomit that looks like coffee grounds. Seek immediate medical attention if any of these rare but very serious side effects occur: trouble breathing, severe dizziness, fainting, fast/slow/irregular heartbeat. 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

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).