EMEND 80 mg hard capsules Aprepitant - United Kingdom[英国药品]

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EMEND 80 mg hard capsules Aprepitant

2014-01-15 17:35:46 来源: 作者: 【大中小】浏览:393次评论:0条

For doctors

What is it and how is it used?

EMEND is used in combination with other medicines to prevent nausea and vomiting caused by chemotherapy (cancer treatment).

What do you have to consider before using it?

Do not take EMEND

Take special care with EMEND

EMEND is not for use in children and adolescents under 18 years.

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

EMEND should be used with caution when taken with other medicines.

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

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

Taking EMEND with food and drink
EMEND can be taken with or without food.

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

Birth control medicines (these can include birth control pills, skin patches, implants, and certain Intrauterine devices [IUDs] that release hormones) may not work adequately; another or additional form of contraception should be used during treatment with EMEND and for up to 2 months after using EMEND.

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

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

Important information about some of the ingredients of EMEND
EMEND contains sucrose. 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 EMEND exactly as your doctor has instructed you.

The recommended oral dose of EMEND is
one 125 mg capsule 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule each morning for the 2 days following your chemotherapy treatment.

Your doctor may substitute fosaprepitant 115 mg (which is converted to aprepitant in your body) for oral EMEND (125 mg) on Day 1 only of your treatment. Fosaprepitant is given via an intravenous infusion (a drip), 30 minutes prior to chemotherapy. You will still need to take one 80 mg capsule by mouth of EMEND each morning for the 2 days following your chemotherapy treatment.

EMEND should be swallowed whole with some liquid.

If you take more EMEND than you should
Do not take more capsules than the doctor recommends. If you do take too many capsules, contact your doctor immediately.

If you forget to take EMEND
If you have missed a dose, contact your doctor for advice.

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, EMEND 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 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:

Single cases of the following have been reported:

Since the product has been on the market, the following side effects have been reported (frequency not known):

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 EMEND after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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

Do not remove the capsule from its blister until you are ready to take it.

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?

Emend is a medicine containing the active substance aprepitant. It is available as capsules (white and yellow: 40 mg; white: 80 mg; white and pink: 125 mg).

What is it used for?

Emend is an anti-emetic (a medicine that prevents nausea [feeling sick] and vomiting). Emend 80 mg and 125 mg capsules are used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer) in adults. Emend 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). Emend makes chemotherapy more tolerable for the patient.
Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults. This is nausea and vomiting that a patient can experience after surgery.
The medicine can only be obtained with a prescription.

How is it used?

In chemotherapy, the usual dose of Emend is one 125 mg capsule by mouth one hour before the start of chemotherapy. After chemotherapy, one 80 mg capsule is taken each day for the next two days. It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5HT antagonist’ (such as ondansetron).
In PONV, the usual dose is one 40 mg capsule given within the three hours before the patient is anaesthetised (‘put to sleep’).
Emend capsules should be swallowed whole, with or without food.

How does it work?

Emend is a neurokinin 1 (NK1) receptor antagonist. It stops a chemical in the body (substance P) from binding to the NK1 receptors. When substance P attaches to these receptors, it causes nausea and vomiting. By blocking the receptors, Emend can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

How has it been studied?

In chemotherapy, three main studies have been carried out. The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 patients with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin. All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron. The main measure of effectiveness was the number of patients who had nausea and vomiting in the five days after receiving chemotherapy.
In PONV, two studies were carried out in a total of 1,727 patients, most of whom were women undergoing gynaecological operations. Two doses of Emend (40 and 125 mg) were compared with ondansetron given as an injection. The studies measured how many patients had a ‘complete response’, which was defined as no vomiting and no need for any other medication to control nausea and vomiting in the 24 hours after the operation.

What benefits has it shown during the studies?

In the chemotherapy studies, adding Emend to the standard combination was more effective than the standard combination alone. Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523). The effectiveness of Emend was also seen during a further five cycles of chemotherapy. In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
In PONV, Emend was as effective as ondansetron. Looking at the results of both studies together, 55% of the patients taking Emend at a dose of 40 mg were ‘complete responders’ (298 out of 541), compared with 49% of the patients who received ondansetron (258 out of 526).

What is the risk associated?

The most common side effect of Emend at all doses (seen in between 1 and 10 patients in 100) is increased liver enzymes. At 80 mg and 125 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, dizziness, hiccups, constipation, diarrhoea, dyspepsia (indigestion), eructation (burping), anorexia (loss of appetite), and asthenia (weakness) or fatigue (tiredness). For the full list of all side effects reported with Emend, see the Package Leaflet.
Emend should not be used in people who may be hypersensitive (allergic) to aprepitant or any of the other ingredients. Emend 80 mg and 125 mg must not be taken with the following medicines:

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Emend’s benefits are greater than its risks for the prevention of PONV in adults, and of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in adults. The Committee recommended that Emend be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Emend to Merck Sharp & Dohme Ltd on 11 November 2003. The marketing authorisation was renewed on 11 November 2008.

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