SUTENT® (sunitinib malate) Healthcare Team

Know who is on your team

You likely already have a healthcare team. It’s made up of all the people who are helping you through your treatment. They may include:

Your primary care doctor who focuses on your general health

An oncologist who is trained to diagnose and treat your cancer

A urologist who treats problems of your urinary system

An oncology nurse who provides you with treatment education and support

An oncology social worker who is specially trained to support you during cancer treatment

A patient navigator who can help guide you through the medical process

Your family and friends who help you throughout treatment

Let people help. And help them back.

Your friends and family want to help, but they need direction from you. To get started:

Talk with them about your current challenges

Ask them for help with specific tasks

Thank them for what they do

Remember, too, that this is an emotional journey for them as well as you. They may be frustrated that they can’t help you as much as they’d like. They may be stressed at any changes in roles. Children may feel scared or confused. But while tough times can strain relationships, such challenges can strengthen them, too. Talking it all out can be a great way to keep everyone staying positive and feeling connected and provide you with the best healthcare support.

If you have questions, ask them

Don’t be afraid to ask questions. Your doctor and nurse want you to take an active role in your treatment. And one way to do that is by learning all you can about your treatment.

Here are a few questions to ask your doctor during upcoming visits:

Before starting treatment:

What do we currently know about my cancer (stage, size, spread, etc)?

What is the goal of treatment at this point in time?

What treatment do you recommend? Why?

How long will the treatment last?

How much will SUTENT cost?

How will I pay for treatment if I don’t have insurance for the SUTENT cost?

How will I feel during treatment? Are there side effects I should be aware of?

Should I seek a second opinion?

Is there a way to get a hold of you after hours if I need to?

When starting SUTENT:

How does SUTENT work?

What SUTENT side effects should I expect?

What side effects or changes should I tell you about right away?

Can some SUTENT side effects be managed?

What should I do if I miss a dose of SUTENT?

How can you tell if the treatment is working?

Do I need to make any lifestyle changes while taking SUTENT? For example, diet or exercise changes.

Work with your healthcare team

It’s important to make the most of your doctor visits. Here are 3 tips to help you get organized and be prepared:

Keep track. In a journal, note your other medicines, questions you have, and experiences with your condition and treatment. This can help you to share everything that you need to with your healthcare team

Speak up. Be sure your healthcare team knows when you have questions or need more information

Keep contacts handy. To save time, put the direct office numbers and e-mail addresses for your doctors and nurses all in one place

Scroll for Important Safety Information and Indications

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

SUTENT is 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 (Gleevec^®) and it did not stop the cancer from growing or
- you cannot take imatinib mesylate (Gleevec^®).
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 SUTENT is safe or effective in children.

IMPORTANT SAFETY INFORMATION

SUTENT can cause 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 SUTENT:

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 SUTENT. Your healthcare provider may tell you to temporarily or permanently stop taking SUTENT if you develop liver problems.

SUTENT 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. Your healthcare provider may stop your treatment with SUTENT if you have signs and symptoms of heart failure.
Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider immediately if:
- you feel faint or lightheaded, or you pass out
- you feel dizzy
- you feel your heartbeat is irregular or fast
High blood pressure. High blood pressure is common with SUTENT 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. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled.
Bleeding problems. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:
- painful, swollen stomach (abdomen)
- vomiting blood
- black, sticky stools
- bloody urine
- headache or change in your mental status
- coughing up blood
Your healthcare provider:
- can tell you about other symptoms to watch for
- may do blood tests if needed and monitor you for bleeding
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 SUTENT.
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.
Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels and blood clots can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body’s organs such as the brain and kidneys, and can sometimes lead to death. Your healthcare provider may tell you to stop taking SUTENT if you develop TMA.
Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT.
Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including:
- severe rash with blisters or peeling of the skin.
- painful sores or ulcers on the skin, lips, or inside the mouth.
- tissue damage (necrotizing fasciitis).
If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away.
Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:
- tiredness that gets worse and does not go away
- loss of appetite
- problems with heat
- 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
Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Signs and symptoms of low blood sugar may include:
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- feeling jittery
Call your healthcare provider right away if you have any signs or symptoms of severe low blood sugar during your treatment with SUTENT.
Jaw-bone problems (osteonecrosis). Severe jaw-bone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous).
Wound healing problems. Wounds may not heal properly during SUTENT treatment. Tell your healthcare provider if you have or plan to have any surgery before starting or during treatment with SUTENT.
- Your healthcare provider may tell you to temporarily stop taking SUTENT if you are planning to have certain types of surgery.
- Your healthcare provider should tell you when you may start taking SUTENT again after surgery.
Fetal harm. SUTENT can harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. You and your partner should use effective birth control (contraception) during and after treatment with SUTENT.
- Females should continue to use birth control for at least 4 weeks after their last dose of SUTENT.
- Males should continue to use birth control for at least 7 weeks after their last dose of SUTENT.

Before taking SUTENT 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 any surgery or dental procedures
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 breastfeeding or plan to breastfeed. Do not breastfeed during treatment with SUTENT and for at least 4 weeks (1 month) after the last dose.
are pregnant or plan to become pregnant. SUTENT 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 SUTENT.
- You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of SUTENT.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with SUTENT.
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 SUTENT.

SUTENT may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you.

Tell all of your healthcare providers and dentists that you are taking SUTENT. They should talk to the healthcare provider who prescribed SUTENT 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 SUTENT with certain other medicines can cause serious side effects.

You may have an increased risk of severe jaw-bone problems (osteonecrosis) if you take SUTENT 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.

Do not drink grapefruit juice or eat grapefruit. They may cause you to have too much SUTENT in your body.

Do not take St. John’s Wort. It may cause you to have too little SUTENT in your body.

Common side effects of SUTENT include:

tiredness
weakness
diarrhea
pain, swelling, or sores inside of your mouth
nausea
loss of appetite
indigestion
vomiting
stomach-area (abdominal) pain
blisters or rash on the palms of your hands and soles of your feet
high blood pressure
taste changes
low platelet counts

The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color. SUTENT may also cause other skin problems including: dryness, thickness, or cracking of the skin.

These are not all of the possible side effects of SUTENT. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATIONS

SUTENT is 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 (Gleevec^®) and it did not stop the cancer from growing or
- you cannot take imatinib mesylate (Gleevec^®).
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 SUTENT is safe or effective in children.

Gleevec is a registered trademark of Novartis AG.

Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems.

Scroll for Important Safety Information and Indications

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

SUTENT is 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 (Gleevec^®) and it did not stop the cancer from growing or
- you cannot take imatinib mesylate (Gleevec^®).
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 SUTENT is safe or effective in children.

IMPORTANT SAFETY INFORMATION

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

SUTENT 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. Your healthcare provider may stop your treatment with SUTENT if you have signs and symptoms of heart failure.
Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider immediately if:
- you feel faint or lightheaded, or you pass out
- you feel dizzy
- you feel your heartbeat is irregular or fast
High blood pressure. High blood pressure is common with SUTENT 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. Your healthcare provider may temporarily stop your treatment with SUTENT until your high blood pressure is controlled.
Bleeding problems. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:
- painful, swollen stomach (abdomen)
- vomiting blood
- black, sticky stools
- bloody urine
- headache or change in your mental status
- coughing up blood
Your healthcare provider:
- can tell you about other symptoms to watch for
- may do blood tests if needed and monitor you for bleeding
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 SUTENT.
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.
Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels and blood clots can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body’s organs such as the brain and kidneys, and can sometimes lead to death. Your healthcare provider may tell you to stop taking SUTENT if you develop TMA.
Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking SUTENT.
Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including:
- severe rash with blisters or peeling of the skin.
- painful sores or ulcers on the skin, lips, or inside the mouth.
- tissue damage (necrotizing fasciitis).
If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away.
Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:
- tiredness that gets worse and does not go away
- loss of appetite
- problems with heat
- 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
Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Signs and symptoms of low blood sugar may include:
- headache
- drowsiness
- weakness
- dizziness
- confusion
- irritability
- hunger
- fast heartbeat
- sweating
- feeling jittery
Call your healthcare provider right away if you have any signs or symptoms of severe low blood sugar during your treatment with SUTENT.
Jaw-bone problems (osteonecrosis). Severe jaw-bone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous).
Wound healing problems. Wounds may not heal properly during SUTENT treatment. Tell your healthcare provider if you have or plan to have any surgery before starting or during treatment with SUTENT.
- Your healthcare provider may tell you to temporarily stop taking SUTENT if you are planning to have certain types of surgery.
- Your healthcare provider should tell you when you may start taking SUTENT again after surgery.
Fetal harm. SUTENT can harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant. You and your partner should use effective birth control (contraception) during and after treatment with SUTENT.
- Females should continue to use birth control for at least 4 weeks after their last dose of SUTENT.
- Males should continue to use birth control for at least 7 weeks after their last dose of SUTENT.

Before taking SUTENT 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 any surgery or dental procedures
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 breastfeeding or plan to breastfeed. Do not breastfeed during treatment with SUTENT and for at least 4 weeks (1 month) after the last dose.
are pregnant or plan to become pregnant. SUTENT 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 SUTENT.
- You should use effective birth control (contraception) during treatment and for at least 4 weeks after your last dose of SUTENT.
- Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with SUTENT.
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 SUTENT.

SUTENT may cause fertility problems in males and females. Tell your healthcare provider if this is a concern for you.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not drink grapefruit juice or eat grapefruit. They may cause you to have too much SUTENT in your body.

Do not take St. John’s Wort. It may cause you to have too little SUTENT in your body.

Common side effects of SUTENT include:

tiredness
weakness
diarrhea
pain, swelling, or sores inside of your mouth
nausea
loss of appetite
indigestion
vomiting
stomach-area (abdominal) pain
blisters or rash on the palms of your hands and soles of your feet
high blood pressure
taste changes
low platelet counts

These are not all of the possible side effects of SUTENT. For more information, ask your healthcare provider or pharmacist.

INDICATIONS

SUTENT is 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 (Gleevec^®) and it did not stop the cancer from growing or
- you cannot take imatinib mesylate (Gleevec^®).
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 SUTENT is safe or effective in children.

Gleevec is a registered trademark of Novartis AG.

Please see patient Medication Guide and full Prescribing Information, including BOXED WARNING regarding serious liver problems.

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Working with your healthcare team

Know who is on your team

Let people help. And help them back.

If you have questions, ask them

Work with your healthcare team

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS