Plenadren

hydrocortisone

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

What is Plenadren?

Plenadren is a medicine that contains the active substance hydrocortisone. It is available as modified-release tablets (5 mg and 20 mg).

What is Plenadren used for?

Plenadren is used to treat adrenal insufficiency in adults. Adrenal insufficiency (including primary insufficiency or Addison’s disease) is a condition where the adrenal glands (located just above the kidneys) do not produce enough of a steroid hormone called cortisol (also known as the stress hormone because it is released in response to stress). Symptoms include weight loss, muscle weakness, fatigue, low blood pressure, and sometimes darkening of the skin. Adrenal insufficiency can require life-long treatment to replace the missing cortisol.

Because the number of patients with adrenal insufficiency is low, the disease is considered ‘rare’, and Plenadren was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 May 2006.

The medicine can only be obtained with a prescription.

How is Plenadren used?

Plenadren tablets are taken once per day early in the morning, swallowed whole with a glass of water at least 30 minutes before food. The usual daily dose ranges from 20 to 30 mg, but this will need to be individually adjusted according to how the patient responds. In situations of excessive physical or mental stress or illness, patients may need further doses of hydrocortisone. This may be given Plenadren tablets twice or three times daily or conventional immediate-release tablets or injections, either alone or in combination with Plenadren.

How does Plenadren work?

The active substance in Plenadren, hydrocortisone, is the pharmaceutical form of cortisol, the main steroid hormone secreted by the adrenal gland. Hydrocortisone replaces the natural cortisol that is missing in patients with adrenal insufficiency. It has been used in medicines for several decades.

Because it is available as a modified-release tablet, Plenadren releases hydrocortisone over a longer period of time allowing for a once daily dosing.  It is taken early in the morning since the amount of cortisol in the blood normally increases early in the morning in healthy people.

How has Plenadren been studied?

The applicant presented data on experimental models from the scientific literature.

The effects of Plenadren were investigated in one main study involving 64 patients with adrenal insufficiency. Plenadren, given once per day, was compared with conventional hydrocortisone treatment, which is given three times per day. The study looked at the levels of cortisol in the patients’ blood during a 24 hour period following three months of treatment.

What benefit has Plenadren shown during the studies?

In patients taking Plenadren the cortisol levels achieved were considered to be satisfactory for patients with adrenal insufficiency. The overall amount of cortisol absorbed into the blood was around 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatment.

What is the risk associated with Plenadren?

The most common side effect with Plenadren (seen in more than 1 patient in 10) was fatigue. For the full list of all side effects reported with Plenadren, see the package leaflet.

Plenadren must not be used in people who are hypersensitive (allergic) to hydrocortisone or any of the other ingredients.

Why has Plenadren been approved?

The CHMP noted that Plenadren achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency. The Committee also noted that with Plenadren there is the convenience of once daily dosing. Although once daily dosing comes with a risk of cortisol levels being too low in the afternoon, this can be managed by adding further doses of hydrocortisone if needed.

The CHMP concluded that the benefits of Plenadren were greater than its risks and recommended that it be granted marketing authorisation.

Other information about Plenadren

The European Commission granted a marketing authorisation valid throughout the European Union for Plenadren on 3 November 2011.

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

Name Language First published Last updated
Plenadren : EPAR - Summary for the public BG = bălgarski 15/11/2011  
Plenadren : EPAR - Summary for the public ES = español 15/11/2011  
Plenadren : EPAR - Summary for the public CS = čeština 15/11/2011  
Plenadren : EPAR - Summary for the public DA = dansk 15/11/2011  
Plenadren : EPAR - Summary for the public DE = Deutsch 15/11/2011  
Plenadren : EPAR - Summary for the public ET = eesti keel 15/11/2011  
Plenadren : EPAR - Summary for the public EL = elliniká 15/11/2011  
Plenadren : EPAR - Summary for the public EN = English 15/11/2011  
Plenadren : EPAR - Summary for the public FR = français 15/11/2011  
Plenadren : EPAR - Summary for the public IT = italiano 15/11/2011  
Plenadren : EPAR - Summary for the public LV = latviešu valoda 15/11/2011  
Plenadren : EPAR - Summary for the public LT = lietuvių kalba 15/11/2011  
Plenadren : EPAR - Summary for the public HU = magyar 15/11/2011  
Plenadren : EPAR - Summary for the public MT = Malti 15/11/2011  
Plenadren : EPAR - Summary for the public NL = Nederlands 15/11/2011  
Plenadren : EPAR - Summary for the public PL = polski 15/11/2011  
Plenadren : EPAR - Summary for the public PT = português 15/11/2011  
Plenadren : EPAR - Summary for the public RO = română 15/11/2011  
Plenadren : EPAR - Summary for the public SK = slovenčina 15/11/2011  
Plenadren : EPAR - Summary for the public SL = slovenščina 15/11/2011  
Plenadren : EPAR - Summary for the public FI = suomi 15/11/2011  
Plenadren : EPAR - Summary for the public SV = svenska 15/11/2011  

This EPAR was last updated on 25/10/2013 .

Authorisation details

Product details

Product details for Plenadren
NamePlenadren
Agency product numberEMEA/H/C/002185
Active substance

hydrocortisone

International non-proprietary name (INN) or common name

hydrocortisone

Therapeutic area Adrenal Insufficiency
Anatomical therapeutic chemical (ATC) code H02AB09
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 Plenadren
Marketing-authorisation holder

ViroPharma SPRL

Revision3
Date of issue of marketing authorisation valid throughout the European Union03/11/2011

Contact address:

ViroPharma SPRL
Rue Montoyer 47
B-1000 Brussels
Belgium

Product information

Product information

10/07/2013  Plenadren -EMEA/H/C/002185 -IAIN/0008

Name Language First published Last updated
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - Product Information SV = svenska 15/11/2011 25/10/2013

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
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013
Plenadren : EPAR - All Authorised presentations SV = svenska 15/11/2011 25/10/2013

Pharmacotherapeutic group

Corticosteroids for systemic use

Therapeutic indication

Treatment of adrenal insufficiency in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Plenadren : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 13/09/2012 25/10/2013

Initial marketing-authorisation documents

Name Language First published Last updated
Plenadren : EPAR - Public assessment report SV = svenska 15/11/2011  
CHMP summary of positive opinion for Plenadren SV = svenska 22/07/2011  

Authorised

This medicine is approved for use in the European Union

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