Afinitor 5 mg tablets Everolimus - United Kingdom[英国药品]

TOP

Afinitor 5 mg tablets Everolimus

2013-12-27 12:39:33 来源: 作者: 【大中小】浏览:426次评论:0条

For doctors

What is it and how is it used?

Afinitor is an anticancer medicine containing the active substance everolimus. Everolimus reduces the blood supply to the tumour and slows down the growth and spread of cancer cells.

Afinitor is used to treat advanced kidney cancer (advanced renal cell carcinoma), where other treatments (so-called “VEGF-targeted therapy”) have not helped stop your disease.

What do you have to consider before using it?

Afinitor will only be prescribed for you by a doctor with experience in cancer treatment. Follow all the doctor’s instructions carefully. They may differ from the general information contained in this leaflet. If you have any questions about Afinitor or why it has been prescribed for you, ask your doctor.

Do not take Afinitor

Take special care with Afinitor
Please tell your doctor before taking Afinitor:

Afinitor may also:

Afinitor is not to be used in children or adolescents (age below 18 years).

You will have regular blood tests during treatment. These will check the amount of blood cells (white blood cells, red blood cells and platelets) in your body to see if Afinitor is having an unwanted effect on these cells. Blood tests will also be carried out to check your kidney function (level of creatinine) and liver function (level of transaminases) and your blood sugar and cholesterol levels. This is because these can also be affected by Afinitor.

Taking other medicines
Afinitor may affect the way some other medicines work. If you are taking other medicines at the same time as Afinitor, your doctor may need to change the dose of Afinitor or the other medicines.

Please tell your doctor or pharmacist if you are taking, have recently taken or before you start any other medicines, including medicines obtained without a prescription. In particular, tell your doctor if you are taking medicines containing any of the following active substances:
The following may increase the risk of side effects with Afinitor:

Taking Afinitor with food and drink
You should take Afinitor at the same time every day, consistently either with or without food. Avoid grapefruit and grapefruit juice while you are on Afinitor.

Pregnancy and breast-feeding
Afinitor could harm an unborn baby or a breast-fed baby.

Afinitor is not recommended during pregnancy. Tell your doctor if you are pregnant or think that you may be pregnant. Your doctor will discuss with you whether you should take Afinitor during your pregnancy.

Women who could potentially become pregnant should use effective contraception during treatment with Afinitor. If, despite these measures, you think you may have become pregnant, ask your doctor for advice before taking any more Afinitor.

You should not breast-feed during treatment with Afinitor. Tell your doctor if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Male fertility
Afinitor may affect male fertility. Talk to your doctor if you may wish to father a child.

Driving and using machines
If you feel unusually tired (fatigue is a very common side effect), take special care when driving or using machines.

Important information about some of the ingredients of Afinitor
Afinitor contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How is it used?

Always take Afinitor exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is 10 mg, taken once a day. Your doctor will tell you how many tablets of Afinitor to take.

If you have liver problems, your doctor may start you on a lower dose of Afinitor (5 mg per day).

If you experience certain side effects (see section 4) while you are taking Afinitor, your doctor may lower your dose or stop treatment, either for a short time or permanently.

Take Afinitor once a day, at about the same time every day, consistently either with or without food.

Swallow the tablet(s) whole with a glass of water. Do not chew or crush the tablets.

If you take more Afinitor than you should

If you forget to take Afinitor
If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for the forgotten tablets.

If you stop taking Afinitor
Do not stop taking Afinitor unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects?

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

Side effects may occur with certain frequencies, which are defined as follows:

Very common affects more than 1 user in 10 Common affects 1 to 10 users in 100 Uncommon affects 1 to 10 users in 1,000 Rare affects 1 to 10 users in 10,000 Very rare affects less than 1 user in 10,000 Not known frequency cannot be estimated from the available data.

Tell your doctor immediately if you experience any serious side effects:

Other side effects of Afinitor include:

Very common side effects

Common side effects

Uncommon side effects

Hepatitis B reactivation has been observed in some patients taking Afinitor. Tell your doctor if you experience symptoms of hepatitis B during treatment with Afinitor. The first symptoms may include fever, skin rash, joint pain and inflammation. Other symptoms may include fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), and pain in the upper right abdomen. Pale stools or dark urine may also be signs of hepatitis.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

↑ back to table of contents ↑

For doctors

What is it?

Afinitor is a medicine that contains the active substance everolimus. It is available as pale yellow, elongated tablets (5 and 10 mg).

What is it used for?

Afinitor is used to treat patients with advanced renal cell carcinoma (kidney cancer that has started to spread). It is used when the cancer has got worse during or after previous treatment with a medicine that targets vascular endothelial growth factor (VEGF). VEGF is a protein that stimulates the formation of blood vessels.
Because the number of patients with renal cell carcinoma is low, the disease is considered ‘rare’, and Afinitor was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 5 June 2007. The medicine can only be obtained with a prescription.

How is it used?

Treatment with Afinitor should be started and supervised by a doctor who has experience in the use of anticancer treatments.
The recommended dose of Afinitor is 10 mg once a day. Treatment should continue for as long as the patient benefits from it or until the patient develops unacceptable side effects. The doctor may reduce the dose or stop treatment for a short period if the patient has severe or intolerable side effects. The tablets should be swallowed whole at the same time every day and should not be chewed or crushed. They should be taken consistently with or without food.

How does it work?

The active substance in Afinitor, everolimus, is an anticancer medicine, which acts by blocking a protein called ‘mammalian target of rapamycin’ (mTOR). In the body, everolimus attaches to a protein that is found inside cells to make a ‘complex’. This complex then blocks mTOR. Since mTOR is involved in the control of cell division and the growth of blood vessels, Afinitor prevents the division of cancer cells and reduces their blood supply. This slows down the growth and spread of kidney cancer.

How has it been studied?

The effects of Afinitor were first tested in experimental models before being studied in humans.

Afinitor was compared with placebo (a dummy treatment) in one main study involving 416 patients with advanced renal cell carcinoma that had got worse within six months of stopping treatment with medicines that target VEGF (sunitinib, sorafenib or both). All of the patients also received best supportive care (any medicines or techniques to help patients, but not other anticancer medicines). The main measure of effectiveness was how long the patients lived without the disease getting worse.

What benefits has it shown during the studies?

Afinitor was more effective than placebo at treating patients with advanced renal cell carcinoma. The patients who took Afinitor lived for an average of 4.9 months without the disease getting worse, compared with 1.9 months for the patients who took placebo.

What is the risk associated?

The most common side effects with Afinitor (seen in more than 1 patient in 10) are infections, low levels of lymphocytes and neutrophils (types of white blood cell), haemoglobin (the protein found in red blood cells that carries oxygen around the body) and platelets (components that help the blood to clot), increased levels of glucose (sugar), cholesterol and triglycerides (types of fat) and phosphate, loss of appetite, abnormal taste, pneumonitis (inflammation in the lungs), dyspnoea (difficulty breathing), epistaxis (nosebleeds), cough, stomatitis (inflammation of the lining of the mouth), diarrhoea, mucosal inflammation (inflammation of the moist body surfaces), vomiting, nausea (feeling sick), increased levels of alanine aminotransferase and aspartate aminotransferase (liver enzymes), rash, dry skin, pruritus (itching), increased levels of creatinine (a breakdown product of muscle), fatigue (tiredness), asthenia (weakness) and peripheral oedema (swelling of the arms and legs). For the full list of all side effects reported with Afinitor, see the Package Leaflet.
Afinitor should not be used in people who may be hypersensitive (allergic) to everolimus, to other rapamycin derivatives (substances with a similar structure to everolimus) or to any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Afinitor’s benefits are greater than its risks for the treatment of patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with VEGF-targeted therapy. The Committee recommended that Afinitor be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Afinitor to Novartis Europharm Limited on 03 August 2009.

The summary of opinion of the Committee for Orphan Medicinal Products for Afinitor is available here.

↑ back to table of contents ↑