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VOTRIENT

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND APPROVED USE

Before taking VOTRIENT, tell your health care provider if you have or had liver problems. Some people may develop liver damage while taking VOTRIENT. VOTRIENT can cause serious liver problems including death. Your health care provider will do blood tests to check your liver before you start and while you take VOTRIENT. Tell your health care provider right away if you have yellow eyes or skin, dark urine, tiredness, nausea or vomiting, loss of appetite, pain in the right upper side of your stomach area, or if you bruise easily. Your health care provider may need to prescribe a lower dose of VOTRIENT for you or tell you to stop taking VOTRIENT if you develop liver problems during treatment.

VOTRIENT may cause irregular or fast heartbeat or fainting.

VOTRIENT may cause heart failure, a condition where your heart does not pump as well as it should and which may result in shortness of breath.

Heart attack and stroke can happen with VOTRIENT and may cause death. Tell your health care provider if you have heart problems. Call your health care provider right away if you have chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness.

VOTRIENT may cause blood clots, which may form in a vein, especially in your legs. Pieces of a blood clot may travel to your lungs. This may be life threatening and cause death. Call your health care provider right away if you have new chest pain, trouble breathing or sudden shortness of breath, leg pain, and swelling of the arms and hands, or legs and feet, a cool or pale arm or leg.

Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenia purpura and hemolytic uremic syndrome, is a condition involving blood clots that can happen while taking VOTRIENT. TMA is accompanied by a decrease in red blood cells and cells that are involved in clotting. TMA may harm organs such as the brain and kidneys.

VOTRIENT may cause bleeding problems, which may be severe and cause death. Tell your health care provider before taking VOTRIENT if you have a history of abnormal bleeding. If you experience unusual bleeding, bruising, or wounds that do not heal, call your health care provider right away.

VOTRIENT may cause a tear (called a perforation) in the stomach or intestinal wall. Fatal perforations have occurred. VOTRIENT may also cause an abnormal connection between 2 parts of your gastrointestinal tract (called a fistula). Call your health care provider if you experience pain or swelling in the stomach area, vomiting blood, or black sticky stools.

VOTRIENT may cause lung problems that may lead to death. Tell your health care provider right away if you develop a cough that will not go away or have shortness of breath.

Reversible posterior leukoencephalopathy syndrome is a condition that can happen while taking VOTRIENT that may cause death. Symptoms may include headaches, seizures, lack of energy, confusion, high blood pressure, loss of speech, blindness or changes in vision, and problems thinking.

High blood pressure can happen with VOTRIENT, including a sudden and severe rise in blood pressure which may be life threatening. These blood pressure increases usually happen in the first several months of treatment. Blood pressure should be well controlled before starting VOTRIENT. Your health care provider should test your blood pressure within 1 week of starting treatment with VOTRIENT and should check it often during treatment. Get medical help right away if you have symptoms of a severe increase in blood pressure, such as severe chest pain, severe headache, blurred vision, confusion, nausea and vomiting, severe anxiety, shortness of breath, or seizures, or if you pass out (become unconscious).

VOTRIENT may cause thyroid problems. Your health care provider should test your thyroid function during treatment with VOTRIENT.

VOTRIENT may affect wound healing. Tell your doctor if you had recent surgery (within the last 7 days) or are going to have surgery.

VOTRIENT may cause you to have too much protein in your urine. Your health care provider will check you for this problem. If there is too much protein in your urine, your health care provider may tell you to stop taking VOTRIENT.

Serious infections can happen with VOTRIENT and can cause death. Call your health care provider if you experience fever; cold symptoms, such as runny nose or a sore throat that does not go away; flu symptoms, such as cough, feeling tired, and body aches; pain when urinating; or cuts, scrapes, or wounds that are red, warm, swollen, or painful.

When used in combination with some other anticancer therapies, VOTRIENT has caused increased toxicity and even death. Tell your health care provider about all of the medicines you are taking, including other anticancer therapies.

FEMALES OF REPRODUCTIVE/CHILDBEARING POTENTIAL. VOTRIENT can harm your unborn baby (cause birth defects or potential loss of pregnancy). You should not become pregnant while you are taking VOTRIENT. You should use effective birth control during treatment with VOTRIENT and for at least 2 weeks after your final dose of VOTRIENT. Talk to your health care provider about the types of birth control that may be right for you during this time.

MALES OF REPRODUCTIVE POTENTIAL. Talk to your doctor if you are a male, even if you have had a vasectomy, and you are with a sexual partner who is pregnant, thinks that she may be pregnant, or who could become pregnant (including those who use other forms of birth control). You should use condoms during sexual intercourse during treatment with VOTRIENT and for at least 2 weeks after your last dose with VOTRIENT.

BREASTFEEDING. It is not known if VOTRIENT passes into your breast milk. Do not breastfeed during treatment with VOTRIENT and for 2 weeks after the final dose.

A collapsed lung can happen with VOTRIENT (called pneumothorax). This may cause shortness of breath. Call your health care provider right away if you experience shortness of breath.

The most common side effects in people with advanced renal cell cancer who take VOTRIENT include:

- Diarrhea
- High blood pressure
- Hair color changes
- Nausea (feeling sick to your stomach) or vomiting
- Loss of appetite

Tell your health care provider right away if you have any side effects.

VOTRIENT may affect the way other medicines work and other medicines may affect how VOTRIENT works. Tell your health care provider about all the medicines you take, including prescription and nonprescription medicines and herbal and dietary supplements.

Do not eat grapefruit or drink grapefruit juice during treatment with VOTRIENT because it may affect how VOTRIENT works.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.

Approved Use:

VOTRIENT^® (pazopanib) tablets is a prescription medicine used to treat people with advanced renal cell cancer (RCC).

It is not known if VOTRIENT is safe and effective in children under 18 years of age.

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Prescribing Info

including Med Guide

Patient Support Line

1-888-669-6682

M-F 8:30 AM-5:00 PM ET

Patient Support Line

1-888-669-6682

M-F 8:30 AM-5:00 PM ET

Important Safety Information, including Boxed WARNING:

Before taking VOTRIENT, tell your health care provider if you have or had liver problems. Some people may develop liver damage while taking VOTRIENT....

Approved Use:

VOTRIENT^® (pazopanib) tablets is a prescription medicine used to treat people with advanced renal cell cancer (RCC).

It is not known if VOTRIENT is safe and effective in children under 18 years of age.

Important Safety Information, including Boxed WARNING:

VOTRIENT may cause irregular or fast heartbeat or fainting.

VOTRIENT may cause heart failure, a condition where your heart does not pump as well as it should and which may result in shortness of breath.

Heart attack and stroke can happen with VOTRIENT and may cause death. Tell your health care provider if you have heart problems. Call your health care provider right away if you have chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness.

VOTRIENT may cause blood clots, which may form in a vein, especially in your legs. Pieces of a blood clot may travel to your lungs. This may be life threatening and cause death. Call your health care provider right away if you have new chest pain, trouble breathing or sudden shortness of breath, leg pain, and swelling of the arms and hands, or legs and feet, a cool or pale arm or leg.

Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenia purpura and hemolytic uremic syndrome, is a condition involving blood clots that can happen while taking VOTRIENT. TMA is accompanied by a decrease in red blood cells and cells that are involved in clotting. TMA may harm organs such as the brain and kidneys.

VOTRIENT may cause bleeding problems, which may be severe and cause death. Tell your health care provider before taking VOTRIENT if you have a history of abnormal bleeding. If you experience unusual bleeding, bruising, or wounds that do not heal, call your health care provider right away.

VOTRIENT may cause a tear (called a perforation) in the stomach or intestinal wall. Fatal perforations have occurred. VOTRIENT may also cause an abnormal connection between 2 parts of your gastrointestinal tract (called a fistula). Call your health care provider if you experience pain or swelling in the stomach area, vomiting blood, or black sticky stools.

VOTRIENT may cause lung problems that may lead to death. Tell your health care provider right away if you develop a cough that will not go away or have shortness of breath.

Reversible posterior leukoencephalopathy syndrome is a condition that can happen while taking VOTRIENT that may cause death. Symptoms may include headaches, seizures, lack of energy, confusion, high blood pressure, loss of speech, blindness or changes in vision, and problems thinking.

High blood pressure can happen with VOTRIENT, including a sudden and severe rise in blood pressure which may be life threatening. These blood pressure increases usually happen in the first several months of treatment. Blood pressure should be well controlled before starting VOTRIENT. Your health care provider should test your blood pressure within 1 week of starting treatment with VOTRIENT and should check it often during treatment. Get medical help right away if you have symptoms of a severe increase in blood pressure, such as severe chest pain, severe headache, blurred vision, confusion, nausea and vomiting, severe anxiety, shortness of breath, or seizures, or if you pass out (become unconscious).

VOTRIENT may cause thyroid problems. Your health care provider should test your thyroid function during treatment with VOTRIENT.

VOTRIENT may affect wound healing. Tell your doctor if you had recent surgery (within the last 7 days) or are going to have surgery.

VOTRIENT may cause you to have too much protein in your urine. Your health care provider will check you for this problem. If there is too much protein in your urine, your health care provider may tell you to stop taking VOTRIENT.

Serious infections can happen with VOTRIENT and can cause death. Call your health care provider if you experience fever; cold symptoms, such as runny nose or a sore throat that does not go away; flu symptoms, such as cough, feeling tired, and body aches; pain when urinating; or cuts, scrapes, or wounds that are red, warm, swollen, or painful.

When used in combination with some other anticancer therapies, VOTRIENT has caused increased toxicity and even death. Tell your health care provider about all of the medicines you are taking, including other anticancer therapies.

FEMALES OF REPRODUCTIVE/CHILDBEARING POTENTIAL. VOTRIENT can harm your unborn baby (cause birth defects or potential loss of pregnancy). You should not become pregnant while you are taking VOTRIENT. You should use effective birth control during treatment with VOTRIENT and for at least 2 weeks after your final dose of VOTRIENT. Talk to your health care provider about the types of birth control that may be right for you during this time.

MALES OF REPRODUCTIVE POTENTIAL. Talk to your doctor if you are a male, even if you have had a vasectomy, and you are with a sexual partner who is pregnant, thinks that she may be pregnant, or who could become pregnant (including those who use other forms of birth control). You should use condoms during sexual intercourse during treatment with VOTRIENT and for at least 2 weeks after your last dose with VOTRIENT.

BREASTFEEDING. It is not known if VOTRIENT passes into your breast milk. Do not breastfeed during treatment with VOTRIENT and for 2 weeks after the final dose.

A collapsed lung can happen with VOTRIENT (called pneumothorax). This may cause shortness of breath. Call your health care provider right away if you experience shortness of breath.

The most common side effects in people with advanced renal cell cancer who take VOTRIENT include:
- Diarrhea
- High blood pressure
- Hair color changes
- Nausea (feeling sick to your stomach) or vomiting
- Loss of appetite

Tell your health care provider right away if you have any side effects.

Do not eat grapefruit or drink grapefruit juice during treatment with VOTRIENT because it may affect how VOTRIENT works.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.

Approved Use:

VOTRIENT^® (pazopanib) tablets is a prescription medicine used to treat people with advanced renal cell cancer (RCC).

It is not known if VOTRIENT is safe and effective in children under 18 years of age.

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Throughout your treatment with VOTRIENT^® (pazopanib) tablets, it will be important to have open, honest conversations with your health care team so that everyone is on the same page. Here are a few tips to get the most out of your appointments:

Take someone with you to appointments. They can take notes so it's easy to remember what your health care provider said
While you're in your health care provider's office, repeat what he said in your own words. Then summarize the facts you've talked about. This can help ensure you understand what he is saying. And if you need more details, ask questions
Between appointments, jot down any questions you have in a notebook so you don't forget them

As you continue to work with your health care team to treat advanced renal cell cancer (advanced kidney cancer), it’s important to remember your personal goals. At times, you may not know where to start the conversation, but be open and honest and concentrate on what’s important to you. When discussing your treatment, keep the following in mind:

What matters most to you? Talk with your health care team about what is most important to you in your daily life. This can help them work with you to prioritize your goals and come up with ways to work toward them

Tip:

Being able to do things on your own is important. Think about what means the most to you. Maybe it is spending time in your garden. Talk about it with your health care team. They can help you plan to make that happen in your daily life.

What are your goals? Share your personal and treatment goals with your team so they know what you’d like to accomplish. And be sure to mention any changes in your goals as you move forward. Together you can figure out the best way to work toward your goals

Tip:

Your goals may change depending on how you feel from day to day. But an activity like walking your dog—whether it's to the mailbox or around the block—can help.

Who is a part of your support system? Let your team know about your support system and what you need as you set and work toward your goals together. Your health care team is a big part of your support system and can also help you find anything else you may need

Tip:

You can have several people as part of your support network. Maybe a spouse is your main source of support, but a friend can be there when you just need a good laugh.

And remember, it’s okay if any of these change or shift over time. Just be sure to share any updates with your health care team so you can move forward together to meet any new goals. The following information can help you know what’s important to share with your health care team.

Do you take any other medicines?

Write a list, and share it with your health care team.

What’s your medical history?

Talk to your health care provider if you have or have had any of the following:

Liver problems. You may need a lower dose of VOTRIENT, or your health care provider may prescribe a different medicine to treat your advanced kidney cancer
High blood pressure
Heart problems or an irregular heartbeat, including QT prolongation
A history of stroke
Headaches, seizures, or vision problems
Coughed up blood in the last 6 months
Bleeding of your stomach or intestines in the last 6 months
A history of a tear (perforation) in your stomach or intestine, or an abnormal connection between 2 parts of your gastrointestinal tract (fistula)
Blood clots in a vein or a lung
Thyroid problems
Recent surgery (within the last 7 days) or are going to have surgery

Do you eat grapefruit or drink grapefruit juice?

Avoid eating grapefruit or drinking grapefruit juice during treatment with VOTRIENT because it may affect how VOTRIENT works.

What medicines are you taking?

VOTRIENT may affect the way other medicines work, and other medicines may affect how VOTRIENT works. Tell your health care provider about all the medicines you take, including

Prescription and nonprescription medicines, vitamins, and herbal supplements
Any medicines that contain simvastatin to treat high cholesterol levels
Any medicines that reduce stomach acid (eg, esomeprazole)

Especially tell your health care provider if you take medicines that can affect how your liver enzymes work, such as

Certain antibiotics (used to treat infections)
Certain medicines used to treat HIV
Certain medicines used to treat depression
Medicines used to treat irregular heartbeats

Considering having a baby?

Tell your health care provider if you are pregnant or plan to become pregnant, because VOTRIENT can harm your unborn baby. You should not become pregnant while you are taking VOTRIENT. It is not known if VOTRIENT passes into your breast milk. You and your health care provider should decide if you will take VOTRIENT or breastfeed. You should not do both.

Tell your health care provider if you are having sex with a partner who is pregnant, thinks they may be pregnant, or who could become pregnant. Even if you had a vasectomy or are taking other forms of birth control, tell your health care provider. You should use condoms during sexual intercourse during treatment with VOTRIENT and for 2 weeks after your last dose.

Ask your health care provider if you are not sure if your medicine is one of these. Also let your health care provider know about any other medical conditions you may have.

Starting the conversation

Use the Conversation Guide to help prepare for appointments (downloadable PDF).

Next: Download Helpful Materials