Sivextro

tedizolid phosphate

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

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

What is Sivextro and what is it used for?

Sivextro 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 tedizolid.

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

How is Sivextro used?

Sivextro is available as a powder to be made up into a solution for infusion (drip) into a vein and as tablets (200 mg). The recommended dose is 200 mg once a day for 6 days. Patients who are started on the infusion may be switched to the tablets when appropriate.

Sivextro can only be obtained with a prescription.

How does Sivextro work?

The active substance in Sivextro, tedizolid, is a type of antibiotic called an oxazolidinone. It works by preventing certain bacteria from making proteins, thereby stopping their growth. Sivextro 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 Sivextro is active can be found in the summary of product characteristics (also part of the EPAR).

What benefits of Sivextro have been shown in studies?

Sivextro was compared with linezolid (another oxazolidinone) in two main studies involving a total of 1,333 patients with acute bacterial infections of the skin and of skin structures, such as cellulitis, skin abscesses and wound infections. These also included infections caused by MRSA. In both studies patients received 6 days of treatment with Sivextro which was compared with a 10-day treatment of linezolid.

In both studies, the main measure of effectiveness was the number of patients whose infection was cured after treatment.

Sivextro was at least as effective as linezolid at curing the infection. 85.5% of patients treated with Sivextro in the first study and 88.0% in the second study were cured, compared with 86.0% and 87.7% respectively of patients treated with linezolid.

What are the risks associated with Sivextro?

The most common side effects with Sivextro (which may affect between 2 and 7 people in 100) are nausea (feeling sick), headache, diarrhoea and vomiting. These side effects were generally of mild or moderate severity.

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

Why is Sivextro approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Sivextro’s benefits are greater than its risks and recommended that it be approved for use in the EU. Although the infections in the studies were not severe, the CHMP considered that the results also apply to severe infections. In light of the need for new antibiotics targeting multi-resistant bacteria, especially those available as an oral (given by mouth) formulation, the CHMP concluded that Sivextro could be a valuable alternative treatment option for bacterial infections of the skin and of skin structures. Sivextro’s safety profile is comparable to that of linezolid and was considered acceptable.

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

A risk management plan has been developed to ensure that Sivextro 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 Sivextro, 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 Sivextro

The European Commission granted a marketing authorisation valid throughout the European Union for Sivextro on 23 March 2015.

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

Name Language First published Last updated
Sivextro : EPAR - Summary for the public BG = bălgarski 2015-03-26  
Sivextro : EPAR - Summary for the public ES = español 2015-03-26  
Sivextro : EPAR - Summary for the public CS = čeština 2015-03-26  
Sivextro : EPAR - Summary for the public DA = dansk 2015-03-26  
Sivextro : EPAR - Summary for the public DE = Deutsch 2015-03-26  
Sivextro : EPAR - Summary for the public ET = eesti keel 2015-03-26  
Sivextro : EPAR - Summary for the public EL = elliniká 2015-03-26  
Sivextro : EPAR - Summary for the public EN = English 2015-03-26  
Sivextro : EPAR - Summary for the public FR = français 2015-03-26  
Sivextro : EPAR - Summary for the public IT = italiano 2015-03-26  
Sivextro : EPAR - Summary for the public LV = latviešu valoda 2015-03-26  
Sivextro : EPAR - Summary for the public LT = lietuvių kalba 2015-03-26  
Sivextro : EPAR - Summary for the public HU = magyar 2015-03-26  
Sivextro : EPAR - Summary for the public MT = Malti 2015-03-26  
Sivextro : EPAR - Summary for the public NL = Nederlands 2015-03-26  
Sivextro : EPAR - Summary for the public PL = polski 2015-03-26  
Sivextro : EPAR - Summary for the public PT = português 2015-03-26  
Sivextro : EPAR - Summary for the public RO = română 2015-03-26  
Sivextro : EPAR - Summary for the public SK = slovenčina 2015-03-26  
Sivextro : EPAR - Summary for the public SL = slovenščina 2015-03-26  
Sivextro : EPAR - Summary for the public FI = suomi 2015-03-26  
Sivextro : EPAR - Summary for the public SV = svenska 2015-03-26  
Sivextro : EPAR - Summary for the public HR = Hrvatski 2015-03-26  
Name Language First published Last updated
Sivextro : EPAR - Risk-management-plan summary (English only) 2015-03-26  

This EPAR was last updated on 06/09/2016 .

Authorisation details

Product details

Product details for Sivextro
NameSivextro
Agency product numberEMEA/H/C/002846
Active substance

tedizolid phosphate

International non-proprietary name (INN) or common name

tedizolid phosphate

Therapeutic area Soft Tissue InfectionsSkin Diseases, Bacterial
Anatomical therapeutic chemical (ATC) code J01
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 Sivextro
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision4
Date of issue of marketing authorisation valid throughout the European Union23/03/2015

Contact address:

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

Product information

Product information

22/07/2016  Sivextro -EMEA/H/C/002846 -IA/0013

Name Language First published Last updated
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - Product Information EN = English 2015-03-26 2016-09-06

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
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06
Sivextro : EPAR - All Authorised presentations EN = English 2015-03-26 2016-09-06

Pharmacotherapeutic group

Therapeutic indication

Sivextro is indicated for the 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
Sivextro : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2015-06-05 2016-09-06

Initial marketing-authorisation documents

Name Language First published Last updated
Sivextro : EPAR - Public assessment report EN = English 2015-03-26  
CHMP summary of positive opinion for Sivextro EN = English 2015-01-23  

Authorised

This medicine is approved for use in the European Union