Ivemend

fosaprepitant

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An overview of Ivemend and why it is authorised in the EU

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.

How is Ivemend used?

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.

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.

What benefits of Ivemend have been shown in studies?

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.

What are the risks 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 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.

Why is Ivemend authorised in the EU?

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.

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

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.

Other information about Ivemend

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

Name Language First published Last updated
Ivemend : EPAR - Medicine overview (English only) 2009-08-12 2018-05-08

This EPAR was last updated on 08/05/2018 .

Authorisation details

Product details

Product details for Ivemend
NameIvemend
Agency product numberEMEA/H/C/000743
Active substance

fosaprepitant

International non-proprietary name (INN) or common name

fosaprepitant

Therapeutic area VomitingCancer
Anatomical therapeutic chemical (ATC) code A04AD12

Publication details

Publication details for Ivemend
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision19
Date of issue of marketing authorisation valid throughout the European Union11/01/2008

Contact address:

Merck Sharp & Dohme Ltd
Hertford Road
Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

30/04/2018  Ivemend -EMEA/H/C/000743 -II/0037

Name Language First published Last updated
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08
Ivemend : EPAR - Product Information EN = English 2009-08-07 2018-05-08

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10
Ivemend : EPAR - All Authorised presentations EN = English 2008-02-05 2013-07-10

Pharmacotherapeutic group

Anti-emetics and antinauseants

Therapeutic indication

Prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and paediatric patients aged 6 months and older.

Ivemend 150 mg is given as part of a combination therapy.

Assessment History

Authorised

This medicine is approved for use in the European Union