Votrient (pazopanib) is used to treat adults with the following types of cancer:
Advanced renal cell carcinoma, a type of kidney cancer. It is used in patients who have not received any previous treatment or in patients who have already been treated for their advanced disease with anticancer medicines called "cytokines".
Certain forms of soft tissue sarcoma, a type of cancer that develops from the soft, supporting tissues of the body. It is used in patients who have been previously treated with chemotherapy because their cancer had spread, or in patients whose cancer has progressed within 12 months after receiving adjuvant or neoadjuvant therapy (treatment received after or before their main treatment).
Efficacy and safety has only been established in certain STS histological tumour subtypes.
This information is based on the European Summary of Product Characteristics. The prescribing information in your country may vary; please consult your local prescribing information and/or contact your local Novartis representative.
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Important Safety Information about Votrient
Votrient can cause severe liver problems, including death. Blood tests should be performed to monitor a patient’s liver before and during treatment with Votrient. Patients should be advised of the signs and symptoms of liver damage. The dose of Votrient may be decreased or Votrient may be stopped. Caution and close monitoring with concomitant use of simvastatin.
Patients should be advised that Votrient may cause irregular or fast heartbeat or fainting. Votrient may cause heart failure; a condition where the 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. Monitoring for signs of heart failure and correction of electrolytes is recommended. Patients should be advised to inform their healthcare providers if they have any history of heart problems and should be informed of the signs and symptoms related to a heart attack or stroke.
Votrient may cause blood clots in a vein, especially in the legs, which may travel to the lungs. This could be life-threatening and cause death. Patients should be advised of the signs and symptoms of blood clots in the legs or lungs. Other blood clotting conditions can happen while taking Votrient such as thrombotic microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS), which may harm organs such as the brain and kidneys.
Votrient may cause bleeding problems, which may be severe and cause death. Patients should advise their healthcare provider of any history of bleeding problems before taking VOTRIENT and report any unusual bleeding, bruising, or wounds that do not heal to their healthcare provider right away. Votrient may cause a tear or perforation in the stomach or intestinal wall, which may be fatal. Votrient may also cause a fistula, which is an abnormal connection between two parts of the gastrointestinal tract. Patients should be instructed to call their healthcare provider if they experience any signs or symptoms of gastrointestinal bleeding.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS) is a condition that can happen while taking Votrient which may cause death. Patients should be instructed to call their healthcare provider right away if they experience any signs and symptoms associated with RPLS.
Votrient may cause high blood pressure, 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. A patient’s blood pressure should be well controlled before starting Votrient and should be checked within the first week of starting Votrient and often during treatment and treatment discontinued upon evidence of hypertensive crisis. Healthcare providers should inform patients of the signs and symptoms of severe increases in blood pressure.
Votrient may cause thyroid problems. Votrient may affect wound healing and patients should inform their healthcare providers of any recent or planned surgery. Votrient may cause too much protein in the urine. Serious infections can happen with Votrient and can cause death. Patients should be instructed on the signs and symptoms of infections. When used in combination with some other anti-cancer therapies, Votrient has caused increased toxicity and even death. Patients should advise their healthcare providers of all medicines they are taking, especially anti-cancer medicines. Votrient can cause birth defects, therefore, patients should be instructed not to become pregnant while taking Votrient and to tell their healthcare provide right away if they become pregnant. A pneumothorax or collapsed lung can happen with Votrient. Air may get trapped in the space between the lung and the chest wall. This may cause shortness of breath.
The most common side effects in people who take Votrient include: anorexia, headache, diarrhea, slow heart rate, high blood pressure, abdominal pain, nausea or vomiting, changes in hair colour, increased liver enzymes, muscle weakness and fatigue.
Other common side effects in people with advanced soft tissue sarcoma who take Votrient include: decreased weight, dizziness, taste changes, coughing, trouble breathing, mouth sores, hair loss, rash, change in skin colour, muscle or bone pain, chest pain, and water retention.
Patients should not eat grapefruit or drink grapefruit juice during treatment with VOTRIENT because it may affect how Votrient works.