Consumer Drug Information

sunitinib

Generic Name: sunitinib (soo NIT in ib)
Brand Names: Sutent

What is sunitinib?

Sunitinib is a cancer medicine that helps the body slow down the growth and reproduction of certain cells, including tumor cells.

Sunitinib is used to treat certain types of advanced or progressive tumors of the digestive system or the kidneys.

Sunitinib may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about sunitinib?

Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Before using sunitinib, tell your doctor if you have high blood pressure, a thyroid disorder, a heart rhythm disorder, or if you have ever had a heart attack, congestive heart failure, a stroke, or blood clots.

To be sure this medication is helping your condition and is not causing certain side effects, your blood and blood pressure may need to be tested at the beginning of each 4-week treatment cycle. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Stop using sunitinib and call your doctor at once if you have chest pain, shortness of breath, sudden numbness or weakness, sudden headache or vision problems, or any unusual bruising or bleeding.

What should I discuss with my healthcare provider before using sunitinib?

Before using sunitinib, tell your doctor if you have:

high blood pressure;
a thyroid disorder;
a heart rhythm disorder;
a personal or family history of "Long QT syndrome";
a history of heart attack or congestive heart failure; or
a history of stroke, blood clots, coronary artery disease, bypass graft surgery, or transient ischemic attack (TIA).

If you have any of these conditions, you may not be able to use sunitinib or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category D: This medication can cause harm to an unborn baby. Do not use sunitinib if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known if sunitinib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sunitinib?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Sunitinib is usually taken once every day for 4 weeks, followed by 2 weeks off the drug. Your doctor will determine how many complete treatment cycles you need based on your condition.

Sunitinib may be taken with or without food.

Store sunitinib at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a sunitinib overdose may include muscle weakness, shaking or chills, and stomach pain.

What should I avoid while taking sunitinib?

Avoid taking an herbal supplement containing St. John's wort at the same time you are taking sunitinib.

Sunitinib side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using sunitinib and call your doctor at once if you have any of these serious side effects:

chest pain, general ill feeling;
uneven heart rate;
feeling short of breath, even with mild exertion;
swelling of your ankles or feet;
weakness, tired feeling, nausea, loss of appetite, weight loss;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
redness, tenderness, sunburn-like peeling of the palms of your hands or the soles of your feet;
bloody, or black, tarry stools;
coughing up blood or vomit that looks like coffee grounds;
easy bruising or bleeding, unusual weakness; or
white patches or sores inside your mouth or on your lips.

Keep using sunitinib and talk with your doctor if you have any of these less serious side effects:

unusual or unpleasant taste in the mouth;
nausea, vomiting, stomach pain or upset;
diarrhea or constipation;
skin rash, hair loss, changes in skin or hair color; or
headache, joint or muscle pain.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Sunitinib Dosing Information

Usual Adult Dose for Renal Cell Carcinoma:

50 mg orally once a day with or without food.

Sunitinib is given on a schedule of four weeks on treatment followed by two weeks off treatment.

Usual Adult Dose for Gastrointestinal Stromal Tumor:

50 mg orally once a day with or without food.

Sunitinib is given on a schedule of four weeks on treatment followed by two weeks off treatment.

What other drugs will affect sunitinib?

Before taking sunitinib, tell your doctor if you are using any of the following drugs:

ketoconazole (Nizoral), itraconazole (Sporanox), voriconazole (VFend);
dexamethasone (Decadron, Dexacort);
nefazodone (Serzone);
seizure medicines such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton);
rifampin (Rifadin, Rimactane), rifabutin (Mycobutin), rifapentin (Priftin);
clarithromycin (Biaxin), telithromycin (Ketek); or
HIV medicines such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase, Fortovase).

If you are using any of these drugs, you may not be able to take sunitinib, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect sunitinib. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about sunitinib written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.