Emend

aprepitant

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This is a summary of the European public assessment report (EPAR) for Emend. 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 Emend.

What is Emend?

Emend is a medicine containing the active substance aprepitant. It is available as capsules (40, 80, 125 and 165 mg) and as a powder to be made up into an oral (by mouth) suspension (125 mg).

What is Emend used for?

Emend is an antiemetic, a medicine that prevents nausea (feeling sick) and vomiting.

Emend is used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer). It is used with chemotherapy that is a moderate or high trigger of nausea and vomiting such as cisplatin, cyclophosphamide, doxorubicin or epirubicin. Emend makes chemotherapy more tolerable for the patient.

Emend 80, 125 and 165 mg capsules are used in adults; children from 12 years of age may be given the 80- or 125-mg capsules and children between 6 months and 12 years of age are given the oral suspension.

Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults. This is nausea and vomiting that a patient can experience after surgery.

The medicine can only be obtained with a prescription.

How is Emend used?

In chemotherapy, the usual dose of Emend in adults and children from 12 years of age is one 125 mg capsule by mouth one hour before the start of chemotherapy. After chemotherapy, one 80 mg capsule is taken each day for the next two days. It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5-HT3 antagonist’ (such as ondansetron).

Emend 165 mg is given to adults only once, one hour before the start of chemotherapy. It is only given on the first day of the chemotherapy and is followed by treatment involving a corticosteroid and a 5-HT3 antagonist.

In children between 6 months and 12 years of age, Emend oral suspension is given together with a 5-HT3 antagonist. The dose of Emend oral suspension to be given depends on the patient’s bodyweight. Emend oral suspension is given one hour before the start of chemotherapy, and for the next 2 days.

In PONV, the usual dose is one 40 mg capsule given to adults within the three hours before the patient is anaesthetised (‘put to sleep’).

How does Emend work?

Emend is a neurokinin 1 (NK1) receptor antagonist. It stops a chemical in the body (substance P) from binding to the NK1 receptors. When substance P attaches to these receptors, it causes nausea and vomiting. By blocking the receptors, Emend can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

How has Emend been studied?

In chemotherapy, three main studies have been carried out for Emend 80 and 125 mg capsules. The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 adults with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin. All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron. The main measure of effectiveness was the number of patients who had no nausea and vomiting in the five days after receiving chemotherapy.

A fourth study has been carried out with Emend (125 mg capsules or 125 mg oral solution) in 307 children from 6 months to 17 years of age, where Emend, taken with ondansetron (with or without dexamethasone), was compared with ondansetron alone (with or without dexamethasone). The main measure of effectiveness was based on how many patients had a ‘complete response’, which was defined as no vomiting, retching or dry heaves and no need for any other medication to control nausea and vomiting 25 to 120 hours after the start of chemotherapy (delayed phase).The study also looked at how many patients achieved a complete response in the first 24 hours after chemotherapy (acute phase).

Emend 165 mg capsules were compared with the authorised intravenous medicine Ivemend 150 mg. Ivemend contains a substance called fosaprepitant which is converted in the body into aprepitant. Tests were performed to determine that Emend 165 mg produces the same amount of aprepitant in the body as a single dose of 150 mg Ivemend.

In PONV, two studies were carried out in a total of 1,727 adult patients, most of whom were women undergoing gynaecological operations. Two doses of Emend (40 and 125 mg as capsules) were compared with ondansetron given as an injection. The studies measured how many patients had a complete response, which was defined as no vomiting and no need for any other medication to control nausea and vomiting in the 24 hours after the operation.

What benefit has Emend shown during the studies?

In the chemotherapy studies in adults, adding Emend to the standard combination was more effective than the standard combination alone. Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523). The effectiveness of Emend was also seen during a further five cycles of chemotherapy. In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).

In the study in children, around 51% (77 out of 152) of children given Emend with ondansetron had a complete response 25 to 120 hours after beginning chemotherapy, compared with 26% (39 out of 150) of children given ondansetron alone. Emend was also shown to be effective in the first 24 hours after chemotherapy.

Emend 165 mg capsules were shown to be bioequivalent to Ivemend 150 mg, which means that like Ivemend it can also be used to prevent nausea and vomiting caused by chemotherapy.

In PONV, Emend was as effective as ondansetron. Looking at the results of both studies together, 55% of the patients (298 out of 541) taking Emend capsules at a dose of 40 mg had a complete response, compared with 49% of the patients who received ondansetron (258 out of 526).

What is the risk associated with Emend?

The most common side effect of Emend at all doses in adults (seen in between 1 and 10 patients in 100) is increased liver enzymes. At a dose of 80, 125 and 165 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, hiccups, constipation, dyspepsia (indigestion), loss of appetite, and fatigue (tiredness). In children, the most common side effects are hiccups and flushing. For the full list of all side effects reported with Emend, see the package leaflet.

Emend 80 mg and 125 mg must not be taken with the following medicines:

  • pimozide (used to treat mental illness);
  • terfenadine, astemizole (commonly used to treat allergy symptoms - these medicines may be available without a prescription);
  • cisapride (used to relieve certain stomach problems).

For the full list of restrictions with Emend, see the package leaflet.

Why has Emend been approved?

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

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

A risk management plan has been developed to ensure that Emend is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Emend, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Emend:

The European Commission granted a marketing authorisation valid throughout the European Union for Emend on 11 November 2003.

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

Name Language First published Last updated
Emend : EPAR - Summary for the public BG = bălgarski 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public ES = español 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public CS = čeština 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public DA = dansk 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public DE = Deutsch 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public ET = eesti keel 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public EL = elliniká 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public EN = English 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public FR = français 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public IT = italiano 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public LV = latviešu valoda 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public LT = lietuvių kalba 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public HU = magyar 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public MT = Malti 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public NL = Nederlands 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public PL = polski 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public PT = português 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public RO = română 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public SK = slovenčina 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public SL = slovenščina 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public FI = suomi 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public SV = svenska 20/10/2008 01/02/2016
Emend : EPAR - Summary for the public HR = Hrvatski 20/10/2008 01/02/2016

This EPAR was last updated on 12/04/2016 .

Authorisation details

Product details

Product details for Emend
NameEmend
Agency product numberEMEA/H/C/000527
Active substance

aprepitant

International non-proprietary name (INN) or common name

aprepitant

Therapeutic area Postoperative Nausea and VomitingVomitingCancer
Anatomical therapeutic chemical (ATC) code A04AD12

Publication details

Publication details for Emend
Marketing-authorisation holder

Merck Sharp & Dohme Ltd.

Revision21
Date of issue of marketing authorisation valid throughout the European Union11/11/2003

Contact address:

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

Product information

Product information

23/03/2016  Emend -EMEA/H/C/000527 -IB/0051/G

Name Language First published Last updated
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016
Emend : EPAR - Product Information HR = Hrvatski 12/08/2009 12/04/2016

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
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016
Emend : EPAR - All Authorised presentations HR = Hrvatski 05/09/2006 12/04/2016

Pharmacotherapeutic group

Anti-emetics and antinauseants

Therapeutic indication

Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.

Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).

Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.

Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Emend : EPAR - Procedural steps taken before authorisation HR = Hrvatski 05/09/2006  
Emend : EPAR - Scientific Discussion HR = Hrvatski 05/09/2006  

Authorised

This medicine is approved for use in the European Union