Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
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.
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
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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.