MedPath
EMA Approval

Ivemend

A04AD12

aprepitant

Antiemetics and antinauseants

fosaprepitant

VomitingCancer

Basic Information

EMA regulatory identification and product classification information

EMA Identifiers

ATC CodeA04AD12
EMA European Classification

Overview Summary

Comprehensive product overview and regulatory summary

Ivemend is a medicine for preventing nausea (feeling sick) and vomiting caused by chemotherapy cancer medicines.

It is used in adults and children from 6 months of age who are undergoing chemotherapy known to cause moderate or severe nausea and vomiting.

It contains the active substance fosaprepitant.

Authorisations (1)

EMEA/H/C/000743

Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands

Authorised

January 11, 2008

Active Substances (1)

fosaprepitant

Documents (16)

Ivemend : EPAR - Public assessment report

February 4, 2008

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Procedural steps taken and scientific information after authorisation (archive)

August 11, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Procedural steps taken and scientific information after authorisation

August 11, 2009

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Public assessment report

February 4, 2008

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Ivemend-H-C-527-PSUV-0022: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

January 12, 2014

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Procedural steps taken and scientific information after authorisation

April 22, 2025

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Medicine overview

August 11, 2009

OVERVIEW_DOCUMENT

Ivemend-H-C-743-II-0037 : EPAR - Assessment report - Variation

May 7, 2018

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - All Authorised presentations

February 4, 2008

AUTHORISED_PRESENTATIONS

CHMP post-authorisation summary of positive opinion for Ivemend

March 22, 2018

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend-H-C-743-P46-0024.1 : EPAR - Assessment Report

May 7, 2015

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Product Information

August 6, 2009

DRUG_PRODUCT_INFORMATION

Ivemend-H-C-743-P46-025/026 : EPAR - Assessment report

September 25, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend : EPAR - Paediatric investigation plan compliance statement

February 6, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend-H-C-PSUSA-1471-201603: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

February 6, 2017

CHANGES_SINCE_INITIAL_AUTHORISATION

Ivemend-H-C-743-X-0006 : EPAR - Assessment Report - Extension

September 23, 2010

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (7)

Question

What benefits of Ivemend have been shown in studies?

Answer

A main study in 2,000 patients with cancer showed that Ivemend was as effective as a Emend another medicine approved for preventing nausea and vomiting. Around 72% of patients treated with either medicine did not have any nausea or vomiting over the five days after receiving chemotherapy.

Question

How is Ivemend used?

Answer

In adults, Ivemend is given as a slow infusion into a vein on the first day of chemotherapy. In children it may be given on the first day or on multiple days through a tube inserted into a large vein near the heart.

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). For more information about using Ivemend, see the package leaflet or contact your doctor or pharmacist.

Question

How does Ivemend work?

Answer

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.

Question

What are the risks associated with Ivemend?

Answer

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 side effects reported with Ivemend, see the package leaflet.

Ivemend must not be used at the same time as pimozide (used to treat mental illness), terfenadine and astemizole (used to treat allergy symptoms) and cisapride (used to relieve certain stomach problems). For the full list of restrictions, see the package leaflet.

Question

Why is Ivemend authorised in the EU?

Answer

A main study showed that Ivemend was as effective as Emend at preventing nausea and vomiting in patients undergoing chemotherapy and its side effects are considered to be manageable. The European Medicines Agency therefore decided that Ivemend’s benefits are greater than its risks and it can be authorised for use in the EU.

Question

What measures are being taken to ensure the safe and effective use of Ivemend?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ivemend have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ivemend are continuously monitored. Side effects reported with Ivemend are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about Ivemend

Answer

Ivemend received a marketing authorisation valid throughout the EU on 11 January 2008.

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