Varuby

rolapitant

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This is a summary of the European public assessment report (EPAR) for Varuby. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Varuby.

For practical information about using Varuby, patients should read the package leaflet or contact their doctor or pharmacist.

What is Varuby and what is it used for?

Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients who are receiving chemotherapy (medicines to treat cancer). Different chemotherapy medicines produce different degrees of nausea and vomiting, and Varuby is used in patients receiving highly or moderately emetogenic (vomit-inducing) chemotherapy.

Varuby acts against delayed nausea and vomiting (when the symptoms occur 24 hours or more after the cancer treatment) and is given with other medicines that help control more immediate nausea and vomiting.

Varuby contains the active substance rolapitant.

How is Varuby used?

Varuby can only be obtained with a prescription and is available as 90-mg tablets. Two tablets are swallowed on the first day of each cycle of chemotherapy, 2 hours or less before chemotherapy starts. Varuby is given with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicine to prevent nausea and vomiting) but how these are given depends on the type of chemotherapy.

For further information, see the summary of product characteristics (also part of the EPAR).

How does Varuby work?

The active substance in Varuby, rolapitant, works by blocking neurokinin-1 (NK1) receptors. Chemotherapy can release a substance in the body (substance P) which attaches to these receptors and stimulates delayed nausea and vomiting. By blocking the receptors, Varuby can prevent this effect. When given with medicines that work by other mechanisms to prevent immediate nausea and vomiting, Varuby can help provide prolonged control against these symptoms after chemotherapy.

What benefits of Varuby have been shown in studies?

In two main studies, Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy. In both studies, one involving 532 patients and the other involving 555 patients, participants also received dexamethasone and granisetron (a 5-HT3 receptor antagonist). Adding the results from both studies together, there was no nausea and vomiting in the period from 24 to 120 hours after chemotherapy in 71% of patients (382 out of 535) given Varuby, while the figure with placebo was 60% (322 out of 535 patients).

Varuby was also more effective than placebo in a third main study when used with dexamethasone and granisetron in patients given moderately emetogenic chemotherapy. There was no delayed nausea and vomiting in 71% of patients given Varuby (475 of 666) compared with 62% of those given placebo (410 of 666).

What are the risks associated with Varuby?

The most common side effects with Varuby (which may affect between 1 and 2 people in 100) are tiredness and headache. Patients taking Varuby must not take St John’s wort (a herbal medicine for mild depression) as this can reduce the effect of Varuby.

For the full list of all side effects and restrictions with Varuby, see the package leaflet.

Why is Varuby approved?

Varuby produced an improvement in the control of delayed nausea and vomiting when added to other standard treatments. In addition, any side effects were manageable and were similar to those usually observed with medicines for nausea and vomiting. Although a number of medicines are approved in the EU for management of chemotherapy-associated nausea and vomiting significant numbers of patients still experience it, and management of nausea in particular remains a challenge. Overall, therefore, Varuby’s benefits are greater than its risks and it has been recommended for approval for use in the EU.

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

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

Other information about Varuby

The European Commission granted a marketing authorisation valid throughout the European Union for Varuby on 20 April 2017.

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

Name Language First published Last updated
Varuby : EPAR - Summary for the public BG = bălgarski 2017-05-31  
Varuby : EPAR - Summary for the public ES = español 2017-05-31  
Varuby : EPAR - Summary for the public CS = čeština 2017-05-31  
Varuby : EPAR - Summary for the public DA = dansk 2017-05-31  
Varuby : EPAR - Summary for the public DE = Deutsch 2017-05-31  
Varuby : EPAR - Summary for the public ET = eesti keel 2017-05-31  
Varuby : EPAR - Summary for the public EL = elliniká 2017-05-31  
Varuby : EPAR - Summary for the public EN = English 2017-05-31  
Varuby : EPAR - Summary for the public FR = français 2017-05-31  
Varuby : EPAR - Summary for the public IT = italiano 2017-05-31  
Varuby : EPAR - Summary for the public LV = latviešu valoda 2017-05-31  
Varuby : EPAR - Summary for the public LT = lietuvių kalba 2017-05-31  
Varuby : EPAR - Summary for the public HU = magyar 2017-05-31  
Varuby : EPAR - Summary for the public MT = Malti 2017-05-31  
Varuby : EPAR - Summary for the public NL = Nederlands 2017-05-31  
Varuby : EPAR - Summary for the public PL = polski 2017-05-31  
Varuby : EPAR - Summary for the public PT = português 2017-05-31  
Varuby : EPAR - Summary for the public RO = română 2017-05-31  
Varuby : EPAR - Summary for the public SK = slovenčina 2017-05-31  
Varuby : EPAR - Summary for the public SL = slovenščina 2017-05-31  
Varuby : EPAR - Summary for the public FI = suomi 2017-05-31  
Varuby : EPAR - Summary for the public SV = svenska 2017-05-31  
Varuby : EPAR - Summary for the public HR = Hrvatski 2017-05-31  

This EPAR was last updated on 31/05/2017 .

Authorisation details

Product details

Product details for Varuby
NameVaruby
Agency product numberEMEA/H/C/004196
Active substance

rolapitant

International non-proprietary name (INN) or common name

rolapitant

Therapeutic area NauseaVomitingCancer
Anatomical therapeutic chemical (ATC) code A04AD
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Varuby
Marketing-authorisation holder

Tesaro UK Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union20/04/2017

Contact address:

Tesaro UK Limited
55 Baker Street 
London 
W1U 7EU 
United Kingdom
 

Product information

Product information

20/04/2017  Varuby -EMEA/H/C/004196 --

Name Language First published Last updated
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  
Varuby : EPAR - Product Information HR = Hrvatski 2017-05-31  

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
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  
Varuby : EPAR - All Authorised presentations HR = Hrvatski 2017-05-31  

Pharmacotherapeutic group

Antiemetics and antinauseants

Therapeutic indication

Prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults.
Varuby is given as part of combination therapy.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Varuby : EPAR - Public assessment report HR = Hrvatski 2017-05-31  
CHMP summary of positive opinion for Varuby HR = Hrvatski 2017-02-24  

Authorised

This medicine is approved for use in the European Union