Sunitinib may cause serious or life-threatening damage to the liver. Tell your doctor if you have or have ever had liver disease or problems with your liver. If you experience any of the following symptoms, call your doctor immediately: itching, yellow eyes or skin, dark urine, or pain or discomfort in the right upper stomach area.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests such as blood tests, X-rays, and electrocardiograms (EKGs, tests that record the electrical activity of the heart) before and during your treatment to be sure that it is safe for you to take sunitinib and to check your body's response to the medication.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sunitinib and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Talk to your doctor about the risks of taking sunitinib.
Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus (tube that connects the throat with the stomach) in people with tumors that were not treated successfully with imatinib (Gleevec) or people who cannot take imatinib. Sunitinib is also used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys). Sunitinib is also used to treat pancreatic neuroendocrine tumors (pNET, a type of tumor that begins in certain cells of the pancreas) in people with tumors that have worsened and cannot be treated with surgery. Sunitinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
Sunitinib comes as a capsule to take by mouth with or without food. For treatment of gastrointestinal stromal tumors (GIST) or advanced renal cell carcinoma (RCC), sunitinib is usually taken once a day for 4 weeks (28 days) followed by a 2-week break before beginning the next dosing cycle. For treatment of pancreatic neuroendocrine tumors (pNET), sunitinib is usually taken once daily. Take sunitinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sunitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them. Do not open the capsules.
You may need to take one or more capsules at a time depending on your dose of sunitinib.
Your doctor may gradually increase or decrease your dose of sunitinib during your treatment. This depends on how well the medication works for you and the side effects you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take sunitinib even if you feel well. Do not stop taking sunitinib without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Do not eat grapefruit or drink grapefruit juice while taking this medication.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Tell your doctor or nurse about the missed dose.
white patches or sores on the lips or in the mouth and throat
pain, irritation, or burning sensation of the lips, tongue, mouth or throat
change in the way things taste
loss of appetite
thin, brittle fingernails or hair
pale or dry skin
sensitivity to heat
nervousness or shaking
heavy, irregular, or missed menstrual periods
dryness, thickness, cracking, or blistering of skin on the palms of the hands and the soles of the feet
muscle, joint, back, or limb pain
pain, burning, numbness, or tingling in the hands or feet
unusual discomfort in cold temperatures
unusual bruising or bleeding
black and tarry stools
red blood in stools
blood in the urine
vomit that looks like coffee grounds
stomach pain, swelling, or tenderness
swelling, tenderness, warmth, or redness of a leg
swelling of the feet or ankles
rapid, irregular, or pounding heartbeat
dizziness or fainting
decreased alertness or concentration
shortness of breath
pain with deep breathing
difficulty falling asleep or staying asleep
coughing up blood
increased urination, especially at night
sudden severe back, stomach, or leg pain
swelling of the eyes, face, lips, tongue, or throat
Sunitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 01/15/2013
AHFS® Consumer Medication Information. © Copyright, 2013. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.