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Faslodex 250 mg solution for injection Fulvestrant
2013-12-08 16:13:58 来源: 作者: 【 】 浏览:434次 评论:0

For doctors

 

What is it and how is it used?

Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers. Estrogens, a type of female sex hormones, can in some cases be involved in the growth of breast cancer.

Faslodex is used to treat advanced or metastatic breast cancer in postmenopausal women.

What do you have to consider before using it?

Do not use Faslodex

Take special care with Faslodex
Tell your doctor if any of these apply to you:

Children
Faslodex is not indicated in children and adolescents under 18 years.

Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).

Pregnancy and breast-feeding
You must not use Faslodex if you are pregnant. If you can become pregnant, you should use effective contraception while being treated with Faslodex.

You must not breast-feed while on treatment with Faslodex.

Driving and using machines
Faslodex is not expected to affect your ability to drive or use machines. However, if you feel tired after treatment do not drive or use machines .

Important information about some of the ingredients of Faslodex

This medicinal product contains 10% w/v ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose.
Harmful for those suffering from alcoholism.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.

How is it used?

The usual dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month with an additional 500 mg dose given 2 weeks after the initial dose.

Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.

What are possible side effects?

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

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

Very common side effects

Common side effects

Uncommon side effects

* Includes side effects for which the exact role of Faslodex cannot be assessed due to the underlying disease.

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

How should it be stored?

Store in a refrigerator (2°C - 8°C)
Keep the pre-filled syringe in the original package, in order to protect from light.

Keep out of the reach and sight of children.

Do not use Faslodex after the expiry date which is stated on the carton or syringe labels after the abbreviation EXP. The expiry date refers to the last day of that month.

Your health care professional will be responsible for the correct storage, use and disposal of Faslodex.

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For doctors

What is it?

Faslodex is a solution for injection that contains the active substance fulvestrant. It is available in prefilled syringes (250 mg).

What is it used for?

Faslodex is used to treat locally advanced or metastatic breast cancer in women who have been through the menopause. It is used for cancer that is ‘oestrogen-receptor positive’ (when the cancer cells have receptors for the hormone oestrogen on their surface). ‘Locally advanced’ means that the cancer has started to spread, and ‘metastatic’ means that the cancer has already spread to other parts of the body. Faslodex is used when the disease has returned during or after treatment with an ‘anti-oestrogen’ (a type of medicine used to treat breast cancer), or when the disease has got worse during treatment with an anti-oestrogen.
The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Faslodex is 500 mg given once a month, with an additional 500-mg dose given two weeks after the first dose. Each dose is given as two slow 250-mg injections lasting one to two minutes, with one injection being given into the muscle of each buttock.

How does it work?

Most types of breast cancer grow in response to the hormone oestrogen. The active substance in Faslodex, fulvestrant, is an anti-oestrogen. It attaches to the receptors for oestrogen on the surface of cells, where it blocks the effects of the hormone and causes the number of oestrogen receptors to fall. As a result, the tumour cells are not stimulated to grow by oestrogen and the growth of the tumour is reduced.
Faslodex is absorbed slowly into the body, with the effects of each dose lasting over a month. The levels of the medicine in the body reach a steady level within a month of starting treatment.

How has it been studied?

Faslodex has been studied in three main studies involving women who had been through the menopause with advanced breast cancer that had come back or got worse after previous hormonal treatment. Two of the studies compared Faslodex taken at a dose of 250 mg once a month with anastrozole (another anticancer medicine) taken at a dose of 1 mg every day in 851 women. The third study compared two doses of Faslodex (250 and 500 mg) in 736 women. In all of the studies, the main measure of effectiveness was how long the patients lived without their disease getting worse.

What benefits has it shown during the studies?

In the first two studies, Faslodex was as effective as anastrozole: the women receiving Faslodex lived for an average of 5.4 months without their disease getting worse, compared with 4.1 months in those taking anastrozole. In the third study, the 500-mg dose of Faslodex was more effective than the 250-mg dose: the women receiving the higher dose lived for an average of 6.5 months without their disease getting worse, compared with 5.5 months in those receiving the lower dose.

What is the risk associated?

The most common side effects with Faslodex (seen in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness), injection-site reactions (such as pain or inflammation) and increased liver enzyme levels in the blood. For the full list of all side effects reported with Faslodex, see the Package Leaflet.
Faslodex should not be used in people who may be hypersensitive (allergic) to fulvestrant or any of the other ingredients. Faslodex must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Faslodex’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex to AstraZeneca UK Limited on 10 March 2004. The marketing authorisation is valid for an unlimited period.

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Name

 

Faslodex 250 mg solution for injection

 

Composition

 

One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Solution for injection.

Clear, colourless to yellow, viscous solution.

 

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

 

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