Nexavar 200 mg film-coated tablets Sorafenib - United Kingdom[英国药品]

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Nexavar 200 mg film-coated tablets Sorafenib

2013-11-29 23:23:48 来源: 作者: 【大中小】浏览:380次评论:0条

For doctors

What is it and how is it used?

Nexavar is used to treat liver cancer ( hepatocellular carcinoma).
Nexavar is also used to treat kidney cancer ( advanced renal cell carcinoma) at an advanced stage when standard therapy has not helped to stop your disease or is considered unsuitable.

Nexavar is a so-called multikinase inhibitor. It works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.

What do you have to consider before using it?

Do not take Nexavar

Take special care with Nexavar

Tell your doctor if any of these affect you. You may need treatment for them, or your doctor may decide to change your dose of Nexavar, or stop treatment altogether. See also Possible Side Effects, section 4.

Taking other medicines
Some medicines may affect Nexavar, or be affected by it. Tell your doctor or pharmacist if you are taking anything in this list:

Tell your doctor or pharmacist if you are taking these or any other medicines (or have taken anything recently) – even those not prescribed.

Pregnancy and breast-feeding
Avoid becoming pregnant while being treated with Nexavar. If you could become pregnant use adequate contraception during treatment. If you become pregnant while being treated with Nexavar, immediately tell your doctor who will decide if the treatment should be continued.

You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby.

Driving and using machines
There is no evidence that Nexavar will affect the ability to drive or to operate machinery.

How is it used?

The usual dose of Nexavar in adults is 2 x 200 mg tablets, twice daily.
This is equivalent to a daily dose of 800 mg or four tablets a day.

Swallow Nexavar tablets with a glass of water, either without food or with a low-fat or moderate fat meal. Do not take this medicine with high fat meals, as this may make Nexavar less effective. If you intend to have a high fat meal take the tablets at least 1 hour before or 2 hours after the meal. Always take Nexavar exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

It is important to take Nexavar at about the same times each day, so that there is a steady amount in the bloodstream.

You will usually carry on taking Nexavar as long as you are getting clinical benefits, and not suffering unacceptable side effects.

If you take more Nexavar than you should Tell your doctor straight away if you (or anyone else) have taken more than your prescribed dose. Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions. Your doctor may tell you to stop taking Nexavar.

If you forget to take Nexavar
If you have missed a dose, take it as soon as you remember. If it is nearly time for the next dose, forget about the missed one and carry on as normal. Do not take a double dose to make up for forgotten individual doses.

Use in children
The use of Nexavar in children below the age of 18 years has not been studied.

What are possible side effects?

Like all medicines, Nexavar can cause side effects although not everybody gets them. This medicine may also affect the results of some blood tests.

Very common side effects
(affects more than 1 user in 10)

Common side effects
( affects 1 to 10 users in 100)

Uncommon side effects
(affects 1 to 10 users in 1,000)

Rare side effects
(affects 1 to 10 users in 10,000)

Other side effects
(of which the frequency cannot be estimated from the available data)

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?

Keep out of the reach and sight of children.

Do not use the tablets after the expiry date which is stated on the carton and on each blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Nexavar is a medicine that contains the active substance sorafenib. It is available as red, round tablets (200 mg).

What is it used for?

Nexavar is used to treat patients who have the following diseases:
- hepatocellular carcinoma (a type of liver cancer);
- advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin-2 has failed or cannot be used.
Because the numbers of patients with hepatocellular carcinoma and renal cell carcinoma are low, the diseases are considered ‘rare’, and Nexavar was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 11 April 2006 and on 29 July 2004.
The medicine can only be obtained with a prescription.

How is it used?

Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Nexavar is given as two tablets twice a day, without food or with a meal that is low in fat. The treatment is continued as long as the patient continues to benefit from it without too many side effects.

How does it work?

The active substance in Nexavar, sorafenib, 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 cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. Nexavar works by slowing down the rate of growth of cancer cells and cutting off the blood supply that keeps cancer cells growing.

How has it been studied?

Nexavar has been compared with placebo (a dummy treatment) in two main studies. The first study involved 602 patients with hepatocellular carcinoma and the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working. The main measure of effectiveness in the hepatocellular carcinoma study was how long the patients survived. The main measures of effectiveness in the advanced renal cell carcinoma study were how long the patients survived and how long the patients lived without their disease getting worse.

What benefits has it shown during the studies?

Nexavar was more effective than placebo in increasing how long the patients survived. In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo. This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study. The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months). This finding was based on the results from 769 patients.

What is the risk associated?

In studies, the most common side effects with Nexavar (seen in more than 1 patient in 10) were lymphopenia (low levels of lymphocytes, a type of white blood cell), hypophosphataemia (low levels of phosphate in the blood), haemorrhage (bleeding), hypertension (high blood pressure), diarrhoea, nausea (feeling sick), vomiting, rash, alopecia (hair loss), ‘hand foot syndrome’ (rash and pain on the palms of the hands and soles of the feet), erythema (redness), pruritus (itchiness), fatigue (tiredness), pain, and increased levels of amylase and lipase (enzymes produced by the pancreas). For the full list of all side effects reported with Nexavar, see the Package Leaflet.
Nexavar should not be used in people who may be hypersensitive (allergic) to sorafenib or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Nexavar’s benefits are greater than its risks for the treatment of hepatocellular carcinoma, and of advanced renal cell carcinoma in patients who have failed prior interferon alfa or interleukin-2 based therapy, or who are considered unsuitable for such therapy. The Committee recommended that Nexavar be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar on 19 July 2006. The marketing authorisation holder is Bayer Schering Pharma AG.

The summaries of opinion of the Committee for Orphan Medicinal Products for Nexavar are available here (hepatocellular carcinoma) and here (renal cell carcinoma).

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