Sunitinib

Sunitinib is a prescription medication used to treat gastrointestinal cancer as well as cancer of the kidney and pancreas. Sunitinib belongs to a group of drugs called kinase inhibitors, which work by blocking the action of the abnormal protein that signals cancer cells to multiply.

This medication comes in capsule form and is taken once daily, with or without food. It is taken for 4 weeks followed by a 2 week break before starting another dosing cycle.

Common side effects of sunitinib include skin yellowing, tiredness, weakness and fever.

Sunitinib is a prescription medication used to treat gastrointestinal cancer as well as cancer of the kidney and pancreas. Specifically, sunitinib is used to treat people with:

• a rare cancer of the stomach, bowel, or esophagus called GIST (gastrointestinal stromal tumor) and when the medicine Gleevec (imatinib mesylate) did not stop the cancer from growing, or you cannot take Gleevec. 
• advanced kidney cancer (advanced renal cell carcinoma or RCC).
• high risk of recurrent RCC following removal of a kidney (nephrectomy) along with other medications. 
• a type of pancreatic cancer known as pancreatic neuroendocrine tumors (pNET), that has progressed and cannot be treated with surgery.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Sunitinib may be found in some form under the following brand names:

• Sutent

Sunitinib may cause serious side effects. See the "Sunitinib Precautions" section.

Common side effects of sunitinib include:

• tiredness 
• weakness 
• fever 
• gastrointestinal symptoms, including diarrhea, nausea, vomiting, mouth sores, upset stomach, abdominal pain, and constipation. Talk with your healthcare provider about ways to handle these problems. 
• rash or other skin changes, including drier, thicker, or cracking skin. 
• blisters or a rash on the palms of your hands and soles of your feet. 
• taste changes 
• loss of appetite 
• pain or swelling in your arms or legs 
• cough 
• shortness of breath 
• bleeding, such as nosebleeds or bleeding from cuts. 

The medicine in sunitinib is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color.

Call your healthcare provider if you have any swelling or bleeding during treatment with sunitinib. These are not all the possible side effects of sunitinib. For more information, ask your healthcare provider or pharmacist.    

Tell your doctor about the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ketoconazole
• itraconazole
• clarithromycin
• atazanavir
• indinavir
• nefazodone
• nelfinavir
• ritonavir
• saquinavir
• telithromycin
• voriconazole
• dexamethasone
• phenytoin
• carbamazepine
• rifampin
• rifabutin
• rifapentin
• phenobarbital
• St. John's Wort

These are not all the possible drug interactions with sunitinib. For more information, ask your healthcare provider.

Serious side effects have been reported with sunitinib including the following:

• Liver problems, including death (see Black Box Warning). Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with sunitinib:
  • itching
  • yellow eyes or skin,
  • dark urine, and
  • pain or discomfort in the right upper stomach area.
    • Your healthcare provider should do blood tests to check your liver function before you start taking sunitinib and during treatment.
• Heart problems. Heart problems may include heart failure and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles. 
• Abnormal heart rhythm changes. Your healthcare provider may do electrocardiograms and blood tests to watch for these problems during your treatment with sunitinib. Tell your healthcare provider if you feel dizzy, faint, or have abnormal heartbeats while taking sunitinib. 
• High blood pressure. Your healthcare provider may check your blood pressure during treatment with sunitinib. Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed.
• Bleeding sometimes leading to death. Tell your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with sunitinib.
  • painful, swollen stomach (abdomen) 
  • vomiting blood 
  • black, sticky stools 
  • bloody urine 
  • headache or change in your mental status

• Hormone problems, including thyroid and adrenal gland problems. Your healthcare provider may do tests to check your thyroid and adrenal gland function during sunitinib treatment. Tell your doctor if you have any of the following signs and symptoms during treatment with sunitinib:
  • tiredness that worsens and does not go away 
  • loss of appetite 
  • heat intolerance 
  • feeling nervous or agitated, tremors 
  • sweating 
  • nausea or vomiting 
  • diarrhea 
  • fast heart rate 
  • weight gain or weight loss 
  • feeling depressed 
  • irregular menstrual periods or no menstrual periods 
  • headache 
  • hair loss

Do not take sunitinib if you are allergic to any of its ingredients.

Grapefruit and grapefruit juice may interact with sunitinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking sunitinib tell your healthcare provider if you:

• have any heart problems 
• have high blood pressure 
• have thyroid problems 
• plan to have surgery 
• have kidney function problems (other than cancer) 
• have liver problems 
• have any bleeding problem 
• have seizures 
• have any other medical conditions 
• if you are having surgery (including dental surgery)
• are pregnant, could be pregnant or plan to become pregnant. Sunitinib may harm an unborn baby. You should not become pregnant while taking sunitinib. Tell your healthcare provider right away if you become pregnant while taking sunitinib. 
• are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take sunitinib or breastfeed. You should not do both.


Tell your healthcare provider about all the medicines you take, including prescription medicines and non-prescription medicines, vitamins, and herbal supplements. Using sunitinib with certain other medicines can cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Talk with your healthcare provider before starting any new medicines.

Tell your healthcare provider if you are pregnant, could be pregnant or plan to become pregnant. Sunitinib may harm an unborn baby. You should not become pregnant while taking sunitinib. Tell your healthcare provider right away if you become pregnant while taking sunitinib. 

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take sunitinib or breastfeed. You should not do both.

• Take sunitinib exactly the way your healthcare provider tells you. 
• Take sunitinib 1 time each day with or without food. 
• If you take sunitinib for GIST or RCC, you will usually take your medicine for 4 weeks (28 days) and then stop for 2 weeks (14 days). This is 1 cycle of treatment. You will repeat this cycle for as long as your healthcare provider tells you to. 
• If you take sunitinib for pNET, take it one time each day until your healthcare provider tells you to stop. 
• Do not open the sunitinib capsules. 
• Do not drink grapefruit juice or eat grapefruit during your treatment with sunitinib. They may cause you to have too much sunitinib in your body. 
• Your healthcare provider may do blood tests before each cycle of treatment. 
• If you miss a dose, take it as soon as you remember. Do not take it if it is close to your next dose. Just take the next dose at your regular time. Do not take more than 1 dose of sunitinib at a time. Tell your healthcare provider about any missed dose. 
• Call your healthcare provider right away, if you take too much sunitinib.

Take sunitinib exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended dose of sunitinib for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is one 50 mg oral dose taken once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2). Sunitinib may be taken with or without food.

The recommended dose of sunitinib for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period. Sunitinib may be taken with or without food.

The recommended dose of sunitinib for treatment of patients with high risk of recurrent RCC following nephrectomy along with other medications is 50 mg orally once daily, with or without food, 4 weeks on treatment followed by 2 weeks off for nine 6-week cycles.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store sunitinib at room temperature, between 59°F and 86°F (15°C to 30°C).
• Keep this and all medicines out of the reach of children.

WARNING: HEPATOTOXICITY

Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with sunitinib:

• itching
• yellow eyes or skin
• dark urine
• pain or discomfort in the right upper stomach area

Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with sunitinib. Your healthcare provider may tell you to temporarily or permanently stop taking sunitinib if you develop liver problems.