Xydalba

dalbavancin

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

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

What is Xydalba and what is it used for?

Xydalba is an antibiotic used in adults to treat acute (short-term) bacterial infections of the skin and of skin structures (tissue below the skin) such as cellulitis (inflammation of the deep skin tissue), skin abscesses and wound infections. It contains the active substance dalbavancin.

Before using Xydalba, doctors should consider official guidance on the appropriate use of antibiotics.

How is Xydalba used?

Xydalba is available as a powder to be made up into a solution for infusion (drip) into a vein and can only be obtained with a prescription. Xydalba is given once a week by an infusion lasting 30 minutes. The recommended dose is 1,500 mg, given either as a single infusion or as 1,000 mg in the first week followed by 500 mg one week later. The dose of Xydalba needs to be reduced in patients with severely impaired kidney function.

How does Xydalba work?

The active substance in Xydalba, dalbavancin, is a type of antibiotic called glycopeptide. It works by preventing certain bacteria from making their own cell walls, thereby killing the bacteria. Dalbavancin has been shown to work against bacteria (such as methicillin resistant Staphylococcus aureus (MRSA)) for which standard antibiotics do not work. A list of bacteria against which Xydalba is active can be found in the summary of product characteristics (also part of the EPAR).

What benefits of Xydalba have been shown in studies?

Xydalba was compared with vancomycin (another glycopeptide) or with linezolid (an antibiotic that can be taken by mouth) in three main studies involving a total of around 2,000 patients with serious infections of the skin and soft tissue under the skin, such as cellulitis, skin abscesses and wound infections. These also included infections caused by MRSA.

Patients who received vancomycin and responded to treatment had the option to switch to linezolid after 3 days. In all the studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.

Xydalba was at least as effective as vancomycin or linezolid at curing the infection. In the 3 studies, between 87% and 94% of patients treated with Xydalba were cured, compared with between 91% and 93% of patients treated with any of the two comparators.

What are the risks associated with Xydalba?

The most common side effects with Xydalba (which may affect between 1 and 3 people in 100) are nausea (feeling sick), diarrhoea and headache. These side effects were generally of mild or moderate severity.

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

Why is Xydalba approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Xydalba’s benefits are greater than its risks and recommended that it be approved for use in the EU. In light of the need for new antibiotics targeting multi-resistant bacteria, the CHMP concluded that Xydalba, which showed activity against certain bacteria resistant to other antibiotics, could be a valuable alternative treatment option. Xydalba’s safety profile is comparable to that of other antibiotics of the glycopeptide class; side effects affecting hearing and kidney function, which are typical for glycopeptides, have not been shown with the proposed regimens of Xydalba in the clinical trials.

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

A risk management plan has been developed to ensure that Xydalba 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 Xydalba, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

Other information about Xydalba

The European Commission granted a marketing authorisation valid throughout the European Union for Xydalba on 19 February 2015.

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

Name Language First published Last updated
Xydalba : EPAR - Summary for the public BG = bălgarski 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public ES = español 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public CS = čeština 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public DA = dansk 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public DE = Deutsch 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public ET = eesti keel 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public EL = elliniká 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public EN = English 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public FR = français 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public IT = italiano 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public LV = latviešu valoda 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public LT = lietuvių kalba 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public HU = magyar 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public MT = Malti 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public NL = Nederlands 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public PL = polski 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public PT = português 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public RO = română 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public SK = slovenčina 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public SL = slovenščina 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public FI = suomi 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public SV = svenska 2015-03-05 2016-05-11
Xydalba : EPAR - Summary for the public HR = Hrvatski 2015-03-05 2016-05-11
Name Language First published Last updated
Xydalba : EPAR - Risk-management-plan summary (English only) 2015-03-05  

This EPAR was last updated on 28/04/2017 .

Authorisation details

Product details

Product details for Xydalba
NameXydalba
Agency product numberEMEA/H/C/002840
Active substance

dalbavancin hcl

International non-proprietary name (INN) or common name

dalbavancin

Therapeutic area Soft Tissue InfectionsSkin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code J01XA04
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 Xydalba
Marketing-authorisation holder

Allergan Pharmaceuticals International Ltd

Revision6
Date of issue of marketing authorisation valid throughout the European Union19/02/2015

Contact address:

Allergan Pharmaceuticals International Ltd
Clonshaugh Business & Technology Park
Coolock
Dublin 17
Ireland

Product information

Product information

17/03/2017  Xydalba -EMEA/H/C/002840 - N/0016

Name Language First published Last updated
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28
Xydalba : EPAR - Product Information EN = English 2015-03-05 2017-04-28

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
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  
Xydalba : EPAR - All Authorised presentations EN = English 2015-03-05  

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Xydalba : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-05-13 2017-04-28

Initial marketing-authorisation documents

Name Language First published Last updated
Xydalba : EPAR - Public assessment report EN = English 2015-03-05  
CHMP summary of positive opinion for Xydalba EN = English 2014-12-19  

Authorised

This medicine is approved for use in the European Union