Ivemend

fosaprepitant

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This 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).

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. For more information about treatment with Ivemend, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Ivemend : EPAR - Summary for the public BG = bălgarski 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public ES = español 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public CS = čeština 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public DA = dansk 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public DE = Deutsch 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public ET = eesti keel 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public EL = elliniká 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public EN = English 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public FR = français 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public IT = italiano 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public LV = latviešu valoda 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public LT = lietuvių kalba 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public HU = magyar 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public MT = Malti 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public NL = Nederlands 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public PL = polski 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public PT = português 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public RO = română 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public SK = slovenčina 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public SL = slovenščina 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public FI = suomi 12/08/2009 14/01/2013
Ivemend : EPAR - Summary for the public SV = svenska 12/08/2009 14/01/2013

This EPAR was last updated on 25/08/2016 .

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

Revision16
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

21/07/2016  Ivemend -EMEA/H/C/000743 -II/0031

Name Language First published Last updated
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016
Ivemend : EPAR - Product Information SV = svenska 07/08/2009 25/08/2016

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 SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013
Ivemend : EPAR - All Authorised presentations SV = svenska 05/02/2008 10/07/2013

Pharmacotherapeutic group

Anti-emetics and antinauseants

Therapeutic indication

Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults.

Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

Ivemend 115 mg is given as part of a combination therapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Ivemend : EPAR - Public assessment report SV = svenska 05/02/2008  

Authorised

This medicine is approved for use in the European Union