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Votrient 200 mg film-coated tablets Hydrochloride
2014-08-14 18:18:20 来源: 作者: 【 】 浏览:385次 评论:0

For doctors

 

What is it and how is it used?

Votrient is a type of medicine called a protein kinase inhibitor. It is used to treat kidney cancer that is advanced or has spread to other organs. It works by preventing the activity of proteins that are involved in the growth and spread of cancer cells.

What do you have to consider before using it?

Don’t take Votrient

Take special care with Votrient
Before you take Votrient
your doctor needs to know:

Votrient is not recommended for people aged under 18. It is not yet known how well it works in this age group.

High blood pressure and Votrient
Votrient can raise your blood pressure. Your blood pressure will be checked before you take Votrient and while you are taking it. If you have high blood pressure you will be treated with medicines to reduce it.

If you are going to have an operation
Your doctor will stop Votrient at least 7 days before your operation as it may affect wound healing. Your treatment will be restarted when the wound has adequately healed.

Conditions you may need to look out for
Votrient can make some conditions worse or cause serious side effects, such as heart conditions, bleeding and thyroid probems. You must look out for certain symptoms while you are taking Votrient to reduce the risk of any problems. See ‘ Conditions you need to look out for’ in Section 4.

Other medicines and Votrient
Tell your doctor or pharmacist if you are taking any other medicines, have taken any recently, or if you start new ones. This includes herbal medicines and other medicines you’ve bought without a prescription.

Some medicines may affect how Votrient works or make it more likely that you’ll have side effects. Votrient can also affect how some other medicines work. These include:

Food and drink with Votrient
Don’t take Votrient with food
, as it affects the way the medicine is absorbed. Take it at least two hours after a meal or one hour before a meal.
Do not drink grapefruit juice while you are being treated with Votrient as this may increase the chance of side effects.

Pregnancy and breast-feeding
Votrient is not recommended if you are pregnant.
The effect of Votrient during pregnancy is not known.

Don’t breast-feed while taking Votrient. It is not known whether the ingredients in Votrient pass into breast-milk. Talk to your doctor about this.

Driving and using machines
Votrient can have side effects that may affect your ability to drive or use machines.

How is it used?

Always take Votrient exactly as your doctor has told you. Check with your doctor or pharmacist if you’re not sure.

How much to take
The usual dose
is two Votrient 400 mg tablets (800 mg pazopanib) taken once a day. This is the maximum dose per day. Your doctor may need to reduce your dose if you get side effects.

When to take
Don’t take Votrient with food.
Take it at least two hours after a meal, or one hour before a meal. For example, you could take it two hours after breakfast or one hour before lunch. Take Votrient at about the same time each day.

Swallow the tablets whole with water, one after the other. Do not break or crush the tablets as it affects the way the medicine is absorbed and may increase the chance of side effects.

If you take too much Votrient
If you taketoo many tablets, contact a doctor or pharmacist for advice. If possible show them the pack, or this leaflet.

If you forget to take Votrient
Don't take the extra tablets to make up for a missed dose. Just take your next dose at the usual time.

Don’t stop Votrient without advice
Take Votrient for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

What are possible side effects?

Like all medicines, Votrient can cause side effects, although not everybody gets them.

Conditions you need to look out for

Heart conditions
Votrient can affect heart rhythm ( QT prolongation) which in some people can develop into a potentially serious heart condition known as Torsade de Pointes. The risks of these problems may be higher for people with an existing heart problem, or who are taking other medicines. You will be checked for any heart problems while you are taking Votrient.

Bleeding
Votrient can cause severe bleeding in the digestive system (such as stomach, gullet, rectum or intestine), or the lungs, kidneys, mouth, vagina and brain, although this is uncommon. Symptoms include:

Thyroid problems
Votrient can lower the amount of thyroid hormone produced in your body. You will be checked for this while you are taking Votrient.

Very common side effects
These may affect more than 1 in 10 people :

Very common side effect that may show up in your blood tests:

Common side effects
These may affect up to 1 in 10 people:

Common side effects that may show up in your blood or urine tests:

Uncommon side effects
These may affect up to 1 in 100 people:

Uncommon side effects that may show up in your blood or urine tests:

If you get side effects

Tell your doctor or pharmacist if any of the side effects listed becomes severe or troublesome, or if you notice any side effects not listed in this leaflet.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Votrient after the expiry date (EXP) which is stated on the bottle and the carton. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

If you have unwanted tablets, don’t put them in waste water or household rubbish. Ask your pharmacist how to dispose of medicines you don’t need. This will help to protect the environment.

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For doctors

What is it?

Votrient is a medicine that contains the active substance pazopanib. It is available as capsule-shaped tablets (pink: 200 mg; white: 400 mg).

What is it used for?

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.

How is it used?

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.

How does it work?

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.

How has it been studied?

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.

What benefits has it shown during the studies?

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.

What is the risk associated?

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.

Why has it been approved?

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.

How has it been studied?

The company that makes Votrient is expected provide results from studies comparing Votrient with sunitinib (another anticancer medicine used in renal cell carcinoma) in 2012.

Further information

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Votrient to Glaxo Group Limited on 14 June 2010. The conditional marketing authorisation is valid for one year, after which it can be renewed.

For more information about treatment with Votrient, read the Package Leaflet (also part of the EPAR).

This summary was last updated in 03-2010.

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Name

 

Votrient 200 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 200 mg pazopanib (as hydrochloride).

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet.

Capsule-shaped, pink, film-coated tablet with GS JT debossed on one side.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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