Sunitinib oral capsules

What is this medication?

SUNITINIB (soo NI ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat specific digestive tract tumors called GISTs, advanced kidney cancer, and certain pancreatic neuroendocrine tumors.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Sutent

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding problems
• dental disease or wear dentures
• diabetes
• having surgery
• heart disease
• high blood pressure
• history of irregular heartbeat
• history of low levels of calcium, magnesium, or potassium in the blood
• kidney disease (other than cancer)
• liver disease
• thyroid disease
• an unusual or allergic reaction to sunitinib, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• cisapride
• dronedarone
• fluconazole
• pimozide
• posaconazole
• saquinavir
• thioridazine

This medicine may also interact with the following medications:

• certain antivirals for HIV or hepatitis
• certain antibiotics like clarithromycin, rifabutin, rifapentine, rifampin, and telithromycin
• certain medicines for fungal infections like ketoconazole, itraconazole, or voriconazole
• certain medicines for irregular heart beat like amiodarone, encainide, flecainide, propafenone, quinidine
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• dexamethasone
• dofetilide
• grapefruit juice
• nefazodone
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• St. John's Wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for regular check ups. Talk to your doctor about any new or unusual health problems. You will need blood work done while you are taking this medicine.

Tell your dentist and dental surgeon that you are taking this medicine. You should not have major dental surgery while on this medicine or for 3 weeks before having this medicine. See your dentist to have a dental exam and fix any dental problems before starting this medicine. Take good care of your teeth while on this medicine. Make sure you see your dentist for regular follow-up appointments.

Before having surgery or dental work, talk to your health care provider to make sure it is ok. This drug can increase the risk of poor healing of your surgical site or wound. You will need to stop this drug for 3 weeks before surgery. After surgery, wait at least 2 weeks before restarting this drug. Make sure the surgical site or wound is healed enough before restarting this drug. Talk to your health care provider if questions.

Do not become pregnant while taking this medicine or for 4 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 7 weeks after stopping it. There is a potential for serious side effects to an unborn child. Men should inform their doctors if they wish to father a child. This medicine may lower sperm counts. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 4 weeks after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• confusion
• changes in vision
• dark urine
• feeling faint or lightheaded, falls
• fever or chills, cough, sore throat
• high blood pressure
• jaw pain, especially after dental work
• mouth sores
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• seizures
• stomach pain
• swelling of feet, legs
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bone or muscle pain
• change in hair color (lighter)
• changes in taste
• diarrhea
• loss of appetite
• nausea, vomiting
• skin that is cracked, dry, thick, yellow or lightened
• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.