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IVEMEND 150 mg powder for solution for infusion Fosaprepitan
2013-12-03 23:00:04 来源: 作者: 【 】 浏览:461次 评论:0

For doctors

 

What is it and how is it used?

IVEMEND contains the active substance fosaprepitant which is converted to aprepitant in your body. IVEMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment) in adults.

What do you have to consider before using it?

Do not use IVEMEND

Take special care with IVEMEND:

Children
IVEMENDis not for use in children and adolescents under 18 years.

Using IVEMEND with other medicines
IVEMEND can affect other medicines both during and after treatment with IVEMEND. There are some medicines that should not be taken with IVEMEND (such as pimozide, terfenadine, astemizole, and cisapride) or that require a dose adjustment (see also Do not use IVEMEND).

The effects of IVEMEND or other medicines might be influenced if you take IVEMEND together with other medicines including those listed below.

Before starting treatment, it is important that you tell your doctor about any other medicines or herbal medicines you are taking, have recently taken, or plan to take, even those obtained without a prescription.

Pregnancy and breast-feeding
You should not use IVEMEND during pregnancy unless clearly necessary. It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving IVEMEND.

For information regarding birth control, see Using IVEMEND with other medicines.

It is not known whether IVEMEND is excreted in human milk; therefore, breast-feeding is not recommended during treatment with IVEMEND. It is important that you tell your doctor if you are breast-feeding or are planning to breast-feed before receiving IVEMEND.

Driving and using machines
It should be taken into account that some people get dizzy and get sleepy after using IVEMEND. If you get dizzy or get sleepy, you should avoid driving or operating machines after using IVEMEND. (See POSSIBLE SIDE EFFECTS).

Important information about some of the ingredients of IVEMEND
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.

How is it used?

The recommended dose of IVEMEND is150 mg fosaprepitant (IVEMEND 150 mg) on Day 1 (day of chemotherapy) only.

The powder is reconstituted and diluted before use. The solution for infusion is given to you by a health care professional, such as a doctor or nurse, via an intravenous infusion (a drip) approximately 30 minutes before you start your chemotherapy treatment.

What are possible side effects?

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

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in every 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).

Common side effects are:

Uncommon side effects are:

Side effects for which the frequency is not known:

Single cases of the following have been reported:

If any of the side effects gets serious, or if you experience 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 this medicine after the expiry date which is stated on the carton and vial after EXP. The first 2 numbers indicate the month; the next 4 numbers indicate the year.

Store in a refrigerator (2°C - 8°C).

The reconstituted and diluted solution is stable for 24 hours at 25°C.

Medicines should not be disposed of via wastewater or house hold 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?

Ivemend is a powder that is made up into a solution for infusion (drip into a vein). It contains the active substance fosaprepitant (115 or 150 mg).

What is it used for?

Ivemend is an anti-emetic (a medicine that prevents nausea [feeling sick] and vomiting). It is used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer) in adults (aged 18 years or over).

Ivemend works with chemotherapy containing cisplatin (a strong trigger of nausea and vomiting) and with chemotherapy that is a moderate trigger of nausea and vomiting (such as cyclophosphamide, doxorubicin or epirubicin). Ivemend makes chemotherapy more tolerable for the patient.

The medicine can only be obtained with a prescription.

How is it used?

Ivemend is given as an infusion around 30 minutes before the start of chemotherapy. It is only given on the first day of chemotherapy. The 115-mg infusion lasts 15 minutes, and the 150-mg infusion lasts 20 to 30 minutes.

Ivemend must always be given together with other medicines that prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5HT antagonist’ (such as ondansetron). If the 115-mg dose of Ivemend is used, the patient must also take aprepitant by mouth for the two days after Ivemend. No aprepitant is given if the 150-mg dose of Ivemend is used.

How does it work?

The active substance in Ivemend, fosaprepitant, is a ‘prodrug’ of aprepitant. This means that it is converted to aprepitant in the body. Aprepitant is a neurokinin 1 (NK1) receptor antagonist. It stops a chemical in the body called ‘substance P’ from attaching to the NK1 receptors. When substance P attaches to these receptors, it causes nausea and vomiting. By blocking these receptors, Ivemend can prevent nausea and vomiting, which often happens during and after chemotherapy. Aprepitant has been authorised in the European Union (EU) as Emend since 2003.

How has it been studied?

To support the use of the 115-mg dose of Ivemend, the company presented information to show that an infusion of 115 mg Ivemend produces the same amount of aprepitant in the body as one 125-mg Emend capsule taken by mouth. It also presented information from three studies used to support the authorisation of Emend, in which Emend 125-mg capsules were used on the first day of chemotherapy in adults receiving chemotherapy including cisplatin or adults with breast cancer receiving cyclophosphamide.

To support the use of the 150-mg dose of Ivemend, the company presented the results of one study comparing a single 150-mg infusion of Ivemend with a three-day course of Emend capsules, both in combination with ondansetron and dexamethasone. The study involved over 2,000 adults with cancer who were receiving their first course of chemotherapy including cisplatin. The main measure of effectiveness was the number of patients who did not have any nausea or vomiting over the five days after receiving chemotherapy.

What benefits has it shown during the studies?

Because Emend 125-mg capsules and the 115-mg infusion of Ivemend produce equivalent levels of aprepitant in the body, the benefit shown by Emend in preventing nausea and vomiting when used on the first day of chemotherapy can be applied to this dose of Ivemend.

The study looking at the 150-mg dose of Ivemend showed that a single 150-mg infusion of Ivemend was as effective as a three-day course of Emend in preventing nausea and vomiting. Around 72% of both groups did not have any nausea or vomiting over the five days after receiving chemotherapy.

What is the risk associated?

The most common side effects with Ivemend (seen in between 1 and 10 patients in 100) are increased liver enzymes, headache, dizziness, hiccups, constipation, diarrhoea, dyspepsia (heartburn), eructation (burping), loss of appetite, and asthenia or fatigue (weakness or tiredness). For the full list of all side effects reported with Ivemend, see the package leaflet.

Ivemend should not be used in people who may be hypersensitive (allergic) to fosaprepitant or aprepitant, polysorbate 80 or any of the other ingredients. It must not be given at the same time as the following medicines:

pimozide used to treat mental illness

terfenadine, astemizole commonly used to treat allergy symptoms - these medicines may be available without prescription

cisapride used to relieve certain stomach problems.

Caution is needed when Ivemend is given with some other medicines. See the package leaflet for full details.

Why has it been approved?

The CHMP decided that Ivemend’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 Ivemend to Merck Sharp & Dohme Ltd on 11 January 2008. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Ivemend, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 08-2010.

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Name

 

IVEMEND 150 mg powder for solution for infusion

 

Composition

 

Each vial contains fosaprepitant dimeglumine equivalent to 150 mg fosaprepitant. After reconstitution and dilution 1 ml of solution contains 1 mg fosaprepitant (1 mg/ml) (see section 6.6).

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Powder for solution for infusion.
White to off-white amorphous powder.

 

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

 

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