IRESSA 250 mg film-coated tablets Gefitinib - United Kingdom[英国药品]

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IRESSA 250 mg film-coated tablets Gefitinib

2014-03-14 17:39:01 来源: 作者: 【大中小】浏览:349次评论:0条

For doctors

What is it and how is it used?

IRESSA contains the active substance gefitinib which blocks a protein called ‘epidermal growth factor receptor’ (EGFR). This protein is involved in the growth and spread of cancer cells.

IRESSA is used to treat adults with non-small cell lung cancer. This cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

What do you have to consider before using it?

Do not take IRESSA

Take special care with IRESSA
Check with your doctor or pharmacist before taking IRESSA

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, may become pregnant or are breast-feeding.
It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.
Do not take IRESSA if you are breast-feeding.

Driving and using machines
IRESSA has no or negligible influence on your ability to drive or use any tools or machines. However, if you feel weak whilst taking this medicine, take care driving or using tools or machines.

Important information about some of the ingredients of IRESSA
This medicine contains lactose. 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 IRESSA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you have trouble swallowing the tablet, dissolve it in half a glass of still (non-fizzy) water. Do not use any other liquids. Do not crush the tablet. Swirl the water until the tablet has dissolved. This may take up to 20 minutes. Drink the liquid straight away. To make sure that you have drunk all of the medicine, rinse the glass very well with half a glass of water and drink it.

If you take more IRESSA than you should
If you have taken more tablets than you should, talk to a doctor or pharmacist straight away.

If you forget to take IRESSA
What to do if you forget to take a tablet, depends on how long it is until your next dose.

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, IRESSA can cause side effects, although not everybody gets them.

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

Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:

Tell your doctor if you notice any of the following side effects:

Very common side effects

Common side effects

Uncommon side effects

Rare side effects

If any of the side effects get 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 IRESSA after the expiry date which is stated on the carton, blister and overwrap foil after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

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?

Iressa is a medicine that contains the active substance gefitinib. It is available as brown tablets (250 mg).

What is it used for?

Iressa is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body). It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).

How is it used?

Treatment with Iressa should be started and supervised by a doctor who has experience with anticancer treatments. The recommended dose is one tablet once a day. The tablet can be dispersed in water for patients who have difficulty swallowing.

How does it work?

The active substance in Iressa, gefitinib, is a protein tyrosine kinase inhibitor. This means that it blocks specific enzymes known as tyrosine kinases. These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells. EGFR is involved in the growth and spread of cancer cells. By blocking EGFR, Iressa helps to slow down the growth and spread of the cancer. Iressa works only in non-small cell lung cancer cells that have a mutation in their EGFR.

How has it been studied?

The effects of Iressa were first tested in experimental models before being studied in humans. In one main study involving 1,217 adult patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with a combination of carboplatin and paclitaxel (other anticancer medicines). The main measure of effectiveness was how long the patients lived without the disease getting worse.
In a second main study involving 1,466 patients with locally advanced or metastatic non-small cell lung cancer, Iressa was compared with docetaxel (another anticancer medicine). The main measure of effectiveness was survival (how long the patients lived). Both studies included patients with and without the EGFR mutation.

What benefits has it shown during the studies?

In the first main study, Iressa was more effective at preventing the cancer from worsening than the combination. Among patients with the EGFR mutation, those who took Iressa lived for an average of nine and a half months without the disease getting worse, compared with about six months for those who took the combination therapy. In the second main study, patient survival among all patients who took Iressa was similar to those who took docetaxel.

What is the risk associated?

The most common side effects with Iressa (seen in more than 1 patient in 10) are loss of appetite, diarrhoea, vomiting, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), increased level of alanine aminotransferase (a liver enzyme) in the blood, skin reactions such as pustular rash, and asthenia (weakness). There is also a risk of interstitial lung disease in patients taking Iressa. For the full list of all side effects reported with Iressa, see the Package Leaflet. Iressa should not be used in people who may be hypersensitive (allergic) to gefitinib or any of the other ingredients. It must not be used in mothers who are breastfeeding.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Iressa’s benefits are greater than its risks for the treatment of adults with locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR. The Committee recommended that Iressa be given marketing authorisation.