Author: Merck Sharp & Dohme Ltd.


Long information

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).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

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 3 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.

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