October 4, 2015
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Sutent Consumer (continued)

SIDE EFFECTS: 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, signs of low blood sugar (such as hunger, shakiness, fast heartbeat, sweating), mental/mood changes (such as decreased alertness, irritability, nervousness), vision changes (such as decreased vision).

Get medical help right away if you have any very serious side effects, including: trouble breathing, severe dizziness, fainting, fast/slow/irregular heartbeat, seizures.

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.

Read the Sutent (sunitinib malate) Side Effects Center for a complete guide to possible side effects

PRECAUTIONS: 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, diabetes.

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.

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.

Wash your hands well to prevent the spread of infections.

Some people taking sunitinib may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are taking this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.

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.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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