Votrient is a medicine that contains the active substance pazopanib. It is available as capsule-shaped tablets (pink: 200 mg; white: 400 mg).
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Votrient is used to treat 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?. ?Advanced? means that the cancer has started to spread.
The medicine can only be obtained with a prescription.
Treatment with Votrient should only be started by a doctor who has experience in giving anticancer medicines. The recommended dose is 800 mg once a day, but this may need to be reduced if the patient has side effects. Votrient should be taken with water but without food, at least one hour before or two hours after a meal. The tablets should be taken whole and should not be broken or crushed.
The active substance in Votrient, pazopanib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors on the surface of cells that are involved in the growth and spread of cancer cells, such as ?VEGFR?, ?PDGFR? and ?KIT?. By blocking these enzymes, Votrient can reduce the growth and spread of the cancer.
The effects of Votrient were first tested in experimental models before being studied in humans.
Votrient has been compared with placebo (a dummy treatment) in one main study involving 435 patients with advanced renal cell carcinoma, some of whom had previously been treated with cytokines. The main measure of effectiveness was how long the patients lived without their disease getting worse.
Votrient was more effective than placebo at treating advanced renal cell carcinoma. On average, the patients who took Votrient lived for 9.2 months without their disease getting worse, compared with 4.2 months for the patients who took placebo.
The most common side effects with Votrient (seen in more than 1 patient in 10) are reduced appetite, dysgeusia (taste disturbances), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, abdominal pain (stomach ache), hair colour change, fatigue (tiredness) and increased blood levels of the liver enzymes alanine aminotransferase and aspartate aminotransferase. For the full list of all side effects reported with Votrient, see the Package Leaflet.
Votrient should not be used in people who may be hypersensitive (allergic) to pazopanib or any of the other ingredients. It must not be used in patients with severe liver problems.
The CHMP decided that Votrient?s benefits are greater than its risks and recommended that it be given marketing authorisation.
Votrient has been given ?conditional approval?. This means that there is more evidence to come about the medicine. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.