Approved Uses:
VOTRIENT® (pazopanib) tablets is a prescription medicine used to treat adults with advanced renal cell cancer (RCC).
VOTRIENT is a prescription medicine used to treat adults with advanced soft tissue sarcoma (STS) who have received chemotherapy in the past. It is not known if VOTRIENT is effective in treating certain STS or certain gastrointestinal (GI) tumors.
It is not known if VOTRIENT is safe and effective in children under 18 years of age.
Important Safety Information, including Boxed WARNING
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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 severe 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.
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- 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
- VOTRIENT may cause bleeding problems, which may be severe and cause death. Call your health care provider right away if you have unusual bleeding, bruising, or wounds that do not heal
- 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, or 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 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 GI 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
- Posterior reversible encephalopathy 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 (BP), loss of speech, blindness or changes in vision, and problems thinking
- High BP can happen with VOTRIENT, including a sudden and severe rise in BP, which may be life-threatening. These BP increases usually happen in the first several months of treatment. BP should be well controlled before starting VOTRIENT. Your health care provider should test your BP 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 BP, 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
- Tumor lysis syndrome (TLS) is a condition that can happen during treatment with VOTRIENT, which may cause death. TLS is caused by a fast breakdown of cancer cells. Your health care provider may do blood tests to check you for TLS. Call your health care provider or get emergency medical help right away if you develop any of the following symptoms during treatment with VOTRIENT: irregular heartbeat, seizures, confusion, muscle cramps or spasms, or a decrease in urine output
- 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). Your health care provider should check to see if you are pregnant before you start taking VOTRIENT. 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 health care provider 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 who take VOTRIENT include:
- Diarrhea
- Hair color changes
- Nausea (feeling sick to your stomach) or vomiting
- Loss of appetite
Other common side effects in people with advanced STS who take VOTRIENT include:
- Feeling tired
- Decreased weight
- Tumor, muscle, or bone pain
- Stomach pain
- Headache
- Taste changes
- Trouble breathing
- Skin color change
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.
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