Somavert

pegvisomant

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

What is Somavert?

Somavert is a powder and solvent that are mixed together to make up a solution for injection. It contains the active substance pegvisomant (10, 15, 20, 25 and 30 mg).

What is Somavert used for?

Somavert is used to treat adults with acromegaly (a rare hormonal disorder that usually occurs in middle-aged adults, which is caused by the pituitary gland producing excess growth hormone).

Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).

The medicine can only be obtained with a prescription.

How is Somavert used?

Treatment with Somavert should be initiated by a doctor who has experience in the treatment of acromegaly. Somavert is given by injection under the skin. The patient first receives a loading dose of 80 mg under medical supervision. Following this, Somavert is given as an injection under the skin of 10 mg once a day. The patient or caregiver can inject Somavert, after being trained by a doctor or a nurse. The doctor should check the response every four to six weeks and adjust the dose if needed. The maximum dose is 30 mg per day.

How does Somavert work?

Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non‑cancerous) tumour. Growth hormone promotes growth during childhood and adolescence. In acromegaly, this overproduction causes overgrowth of bone, swelling of soft tissue (such as the hands and feet), heart disease and other disorders. The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself. By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.

How has Somavert been studied?

Somavert has been studied in 112 patients with acromegaly in a 12-week study. Three different doses of the medicine (10, 15 or 20 mg/day) were compared with placebo (a dummy treatment). The effectiveness was measured by comparing the levels of insulin-like growth factor‑I (IGF‑I) before and at the end of the study. IGF‑I is regulated by human growth hormone and causes growth in the body.

What benefit has Somavert shown during the studies?

Somavert lowered IGF-I levels at all of the doses tested. IGF-I was normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.

What is the risk associated with Somavert?

The most common side effects of Somavert (seen in more than 1 in 10 people) were, headache, diarrhoea and joint pain. The majority of side effects were mild to moderate and of limited duration. Some patients who received Somavert developed anti-growth hormone antibodies (proteins that are produced in response to Somavert), but the clinical importance of this side effect is not known.

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

Why has Somavert been approved?

The CHMP decided that the benefits of Somavert 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 Somavert?

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

Other information about Somavert

The European Commission granted a marketing authorisation valid throughout the European Union for Somavert on 13 November 2002.

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

Name Language First published Last updated
Somavert : EPAR - Summary for the public BG = bălgarski 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public ES = español 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public CS = čeština 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public DA = dansk 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public DE = Deutsch 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public ET = eesti keel 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public EL = elliniká 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public EN = English 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public FR = français 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public IT = italiano 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public LV = latviešu valoda 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public LT = lietuvių kalba 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public HU = magyar 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public MT = Malti 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public NL = Nederlands 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public PL = polski 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public PT = português 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public RO = română 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public SK = slovenčina 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public SL = slovenščina 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public FI = suomi 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public SV = svenska 01/02/2008 10/08/2016
Somavert : EPAR - Summary for the public HR = Hrvatski 01/02/2008 10/08/2016

This EPAR was last updated on 10/08/2016 .

Authorisation details

Product details

Product details for Somavert
NameSomavert
Agency product numberEMEA/H/C/000409
Active substance

pegvisomant

International non-proprietary name (INN) or common name

pegvisomant

Therapeutic area Acromegaly
Anatomical therapeutic chemical (ATC) code H01AX01
Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Somavert
Marketing-authorisation holder

Pfizer Limited

Revision14
Date of issue of marketing authorisation valid throughout the European Union13/11/2002

Contact address:

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

30/06/2016  Somavert -EMEA/H/C/000409 -II/0077

Name Language First published Last updated
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016
Somavert : EPAR - Product Information HR = Hrvatski 11/05/2009 10/08/2016

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
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015
Somavert : EPAR - All Authorised presentations HR = Hrvatski 21/10/2005 14/08/2015

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Treatment of adult patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalize IGF-I concentrations or was not tolerate.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Somavert : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 11/05/2009 10/08/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Somavert : EPAR - Procedural steps taken before authorisation HR = Hrvatski 21/10/2005  
Somavert : EPAR - Scientific Discussion HR = Hrvatski 21/10/2005  

Authorised

This medicine is approved for use in the European Union

More information on Somavert

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 14 February 2001. Somavert was withdrawn from the Community register of orphan medicinal products in November 2012 at the end of the 10-year period of market exclusivity.