Qutenza

capsaicin

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Qutenza?

Qutenza is a cutaneous patch (a patch that delivers a medicine to the skin). It contains the active substance capsaicin (8%).

What is Qutenza used for?

Qutenza is used to treat peripheral neuropathic pain (pain that is caused by damage to the nerves) in adults who do not have diabetes. It can be used alone or together with other painkillers.

The medicine can only be obtained with a prescription.

How is Qutenza used?

Qutenza should be applied by a doctor or by a healthcare professional under the supervision of a doctor. It is applied to the most painful areas of the skin. The painful area should be determined by a doctor and marked on the skin. Qutenza can only be applied to unbroken, non-irritated, dry skin.

Patches can be cut to match the area to cover. No more than four patches should be used on the patient at the same time. Before applying Qutenza, the area must be treated with a local anaesthetic, so that it is numbed. This helps to reduce discomfort. Qutenza should remain in place for 30 minutes for the feet and 60 minutes for other parts of the body. Once the patch is removed, the area is cleaned using the cleansing gel provided. It may take between one day and two weeks for Qutenza to have an effect. The treatment may be repeated every three months depending on the patient’s symptoms.

Qutenza can cause a burning sensation on the skin. Because of this, healthcare professionals should wear nitrile gloves while applying and removing the patch.

How does Qutenza work?

The active substance in Qutenza, capsaicin, is a substance normally found in chilli peppers that is a ‘selective agonist’ of the ‘transient-receptor-potential-vanilloid-1’ (TRPV1) receptor. This means that it stimulates the TRPV1 receptor, which is found in the nociceptors (pain receptors) in the skin. Qutenza contains high doses of capsaicin that are released quickly and overstimulate the TRPV1 receptors. Overstimulating the receptors makes them become ‘desensitised’ and no longer able to respond to the stimuli that normally cause pain in patients with peripheral neuropathic pain.

How has Qutenza been studied?

Qutenza has been compared with control patches containing lower amounts of capsaicin (0.04%) in four main studies involving a total of 1,619 adults with moderate to severe neuropathic pain. All of the patients had neuropathic pain due to either post-herpetic neuralgia (pain that occurs in people who have had shingles, an infection caused by the varicella zoster virus) or HIV-associated neuropathy (damage to the nerves caused by HIV infection). The main measure of effectiveness was the reduction in the 24-hour pain score during the eight or 12 weeks period after application of the patch.

What benefit has Qutenza shown during the studies?

Qutenza was more effective at reducing neuropathic pain than the control patches. In the two studies of patients with post-herpetic neuralgia, the reduction in pain scores after eight weeks was 30 and 32% in patients who were given Qutenza, compared with 20 and 24% in patients who received the control patches. In one of the studies of patients with HIV-associated neuropathy, patients who were given Qutenza experienced a 23% reduction in pain scores after 12 weeks compared with an 11% reduction in patients who were given the control. In the second study of patients with HIV-associated neuropathy, although Qutenza reduced pain by 30% it was not shown to be more effective than the control.

What is the risk associated with Qutenza?

The most common side effects with Qutenza (seen in more than 1 patient in 10) are pain and erythema (redness) at the site of application. For the full list of all side effects reported with Qutenza, see the package leaflet.

Qutenza should not be used in people who may be hypersensitive (allergic) to capsaicin or any of the other ingredients.

Why has Qutenza been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Qutenza’s benefits are greater than its risks and recommended that Qutenza be given marketing authorisation.

Which measures are being taken to ensure the safe use of Qutenza?

The company that makes Qutenza will make sure that an educational programme is available in all Member States for healthcare professionals who will prescribe Qutenza. The programme will include information on how to administer, handle and dispose of Qutenza and on warnings and precautions that should be taken during treatment.

Other information about Qutenza

The European Commission granted a marketing authorisation valid throughout the European Union for Qutenza on 15 May 2009. The marketing-authorisation holder is Astellas Pharma Europe B.V. The marketing authorisation is valid for five years, after which it can be renewed.

Name Language First published Last updated
Qutenza : EPAR - Summary for the public BG = bălgarski 12/11/2009  
Qutenza : EPAR - Summary for the public ES = español 12/11/2009  
Qutenza : EPAR - Summary for the public CS = čeština 12/11/2009  
Qutenza : EPAR - Summary for the public DA = dansk 12/11/2009  
Qutenza : EPAR - Summary for the public DE = Deutsch 12/11/2009  
Qutenza : EPAR - Summary for the public ET = eesti keel 12/11/2009  
Qutenza : EPAR - Summary for the public EL = elliniká 12/11/2009  
Qutenza : EPAR - Summary for the public EN = English 12/11/2009  
Qutenza : EPAR - Summary for the public FR = français 12/11/2009  
Qutenza : EPAR - Summary for the public IT = italiano 12/11/2009  
Qutenza : EPAR - Summary for the public LV = latviešu valoda 12/11/2009  
Qutenza : EPAR - Summary for the public LT = lietuvių kalba 12/11/2009  
Qutenza : EPAR - Summary for the public HU = magyar 12/11/2009  
Qutenza : EPAR - Summary for the public MT = Malti 12/11/2009  
Qutenza : EPAR - Summary for the public NL = Nederlands 12/11/2009  
Qutenza : EPAR - Summary for the public PL = polski 12/11/2009  
Qutenza : EPAR - Summary for the public PT = português 12/11/2009  
Qutenza : EPAR - Summary for the public RO = română 12/11/2009  
Qutenza : EPAR - Summary for the public SK = slovenčina 12/11/2009  
Qutenza : EPAR - Summary for the public SL = slovenščina 12/11/2009  
Qutenza : EPAR - Summary for the public FI = suomi 12/11/2009  
Qutenza : EPAR - Summary for the public SV = svenska 12/11/2009  

This EPAR was last updated on 06/06/2014 .

Authorisation details

Product details

Product details for Qutenza
NameQutenza
Agency product numberEMEA/H/C/000909
Active substance

capsaicin

International non-proprietary name (INN) or common name

capsaicin

Therapeutic area Neuralgia
Anatomical therapeutic chemical (ATC) code N01BX04

Publication details

Publication details for Qutenza
Marketing-authorisation holder

Astellas Pharma Europe B.V.

Revision8
Date of issue of marketing authorisation valid throughout the European Union15/05/2009

Contact address:

Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
The Netherlands

Product information

Product information

23/04/2014  Qutenza -EMEA/H/C/000909 -R/0031

Name Language First published Last updated
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014
Qutenza : EPAR - Product Information SV = svenska 16/11/2009 06/06/2014

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
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010
Qutenza : EPAR - All Authorised presentations SV = svenska 09/06/2009 08/03/2010

Pharmacotherapeutic group

Anesthetics

Therapeutic indication

Qutenza is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Qutenza : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 16/11/2009 06/06/2014

Initial marketing-authorisation documents

Name Language First published Last updated
Qutenza : EPAR - Public assessment report SV = svenska 09/06/2009  
Committee for medicinal products for human use, summary of positive opinion for Qutenza SV = svenska 19/03/2009  

Authorised

This medicine is approved for use in the European Union

More information on Qutenza