Ivemend

Summary

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/11006/2013

EMEA/H/C/000743

EPAR summary for the public

Ivemend

fosaprepitant

This document is a summary of the European public assessment report (EPAR) for Ivemend. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ivemend.

What is Ivemend?

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

What is Ivemend used for?

Ivemend is used with other medicines to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines used to treat cancer) in adults.

Ivemend is used for chemotherapy containing cisplatin (a strong trigger of nausea and vomiting) and for 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 Ivemend 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 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 '5HT₃ antagonist' (such as ondansetron).

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How does Ivemend 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 Ivemend been studied?

Ivemend has been studied in one main 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 benefit has Ivemend shown during the studies?

The study 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 with Ivemend?

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

Ivemend must not be used in people who are 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).

See the package leaflet for full details.

Why has Ivemend been approved?

The CHMP decided that Ivemend's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Ivemend:

The European Commission granted a marketing authorisation valid throughout the European Union for Ivemend on 11 January 2008.

The full EPAR for Ivemend can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 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 12-2012.

Ivemend

EMA/11006/2013

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