Sunitinib

What it is used for

Sunitinib malate is a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. treatment of adult patients with advanced renal cell carcinoma (RCC). adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.

treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. 1.1 Gastrointestinal Stromal Tumor Sunitinib malate capsules are indicated for the treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.

1.2 Advanced Renal Cell Carcinoma Sunitinib malate capsules are indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC). 1.3 Adjuvant Treatment of Renal Cell Carcinoma Sunitinib malate capsules are indicated for the adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.

1.4 Advanced Pancreatic Neuroendocrine Tumors Sunitinib malate capsules are indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

The most important thing to know

Sunitinib malate capsules can cause serious side effects including: Severe liver problems, that can lead to death. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with sunitinib malate capsules: 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 malate capsules.

Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with sunitinib malate capsules if you develop liver problems. See “

How to take it

Take sunitinib malate capsules exactly the way your healthcare provider tells you. Take sunitinib malate capsules 1 time each day with or without food. If you take sunitinib malate capsules 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 malate capsules for pNET, take it 1 time each day until your healthcare provider tells you to stop. Do not drink grapefruit juice or eat grapefruit during your treatment with sunitinib malate capsules. They may cause you to have too much sunitinib malate capsules in your body.

Your healthcare provider may do blood tests before each cycle of treatment to check you for side effects. If you miss a dose of sunitinib malate capsules by less than 12 hours, take the missed dose right away. If you miss a dose of sunitinib malate capsules by more than 12 hours, just take your next dose at your regular time.

Do not make up the missed dose. Tell your healthcare provider about any missed dose. Call your healthcare provider right away, if you take too much sunitinib malate capsules. What are possible side effects of sunitinib malate capsules? Sunitinib malate capsules may cause serious side effects, including: Heart problems. Heart problems may include heart failure, heart attack 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. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with sunitinib malate capsules.

Tell your healthcare provider right away if you feel dizzy, faint, or have abnormal heartbeats during your treatment with sunitinib malate capsules you feel faint or lightheaded, or you pass out dizziness feel your heart beat is irregular or fast High blood pressure. High blood pressure is common with sunitinib malate capsules and may sometimes be severe.

Follow your healthcare provider’s instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high, or if you have any of the following signs or symptoms of high blood pressure: severe headache lightheadedness dizziness change in vision Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed.

Bleeding problems. Bleeding is common with sunitinib malate capsules, but sunitinib malate capsules can also cause severe bleeding problems that can lead to death. Your healthcare provider will monitor you for bleeding and may do blood tests if needed. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with sunitinib malate capsules, including: painful, swollen stomach (abdomen) vomiting blood coughing up blood black, sticky stools bloody urine headache change in your mental status Serious stomach and intestinal problems, that can sometimes lead to death.

Some people have had tears in their stomach or intestine (perforation), or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with sunitinib malate capsules. Tumor lysis syndrome (TLS).

TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS. Abnor

Side effects, and when to stop

” for more information about side effects. What are sunitinib malate capsules? Sunitinib malate capsules are a prescription medicine used to treat: a rare cancer of the stomach, bowel, or esophagus called gastrointestinal stromal tumor (GIST) and when: you have taken the medicine imatinib mesylate and it did not stop the cancer from growing, or you cannot take imatinib mesylate.

advanced kidney cancer (advanced renal cell carcinoma or RCC). adults with kidney cancer that has not spread (localized), and who are at high risk of RCC coming back again after having kidney surgery. a type of pancreatic cancer called pancreatic neuroendocrine tumors (pNET), that has progressed and cannot be treated with surgery.

It is not known if sunitinib malate capsules are safe and effective in children. Before taking sunitinib malate capsules tell your healthcare provider about all of your medical conditions, including if you: have any heart problems have high blood pressure have thyroid problems have a history of low blood sugar or diabetes have kidney function problems (other than cancer) have liver problems have any bleeding problem plan to have surgery or have had a recent surgery.

You should stop taking sunitinib malate capsules at least 3 weeks before planned surgery. See “What are the possible side effects of sunitinib malate capsules?” have seizures have or have had pain in the mouth, teeth or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth are pregnant or plan to become pregnant.

Sunitinib malate capsules can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with sunitinib malate capsules. You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of sunitinib malate capsules.

Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with sunitinib malate capsules. Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 7 weeks after your last dose of sunitinib malate capsules.

Sunitinib malate capsules may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you. are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with sunitinib malate capsules and for at least 4 weeks (1 month) after the last dose. Tell all of your healthcare providers and dentists that you are taking sunitinib malate capsules.

They should talk to the healthcare provider who prescribed sunitinib malate capsules for you, before you have any surgery, or medical or dental procedure. Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements. Using sunitinib malate capsules with certain other medicines can cause serious side effects.

You may have an increased risk of severe jawbone problems (osteonecrosis) if you take sunitinib malate capsules and a bisphosphonate medicine. Especially tell your healthcare provider if you are taking or have taken an osteoporosis medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.