What is Plenadren - Hydrocortisone?
Plenadren is a medicine containing the active substance hydrocortisone. It is available as modified-release capsules (5 mg and 20 mg).
What is Plenadren - Hydrocortisone used for?
Plenadren is used to treat adrenal insufficiency in adults. Adrenal insufficiency (including primary failure or Addison's disease) is a condition in which the adrenal glands (located just above the kidneys) do not sufficiently produce a steroid hormone called cortisol (also known as the hormone of the stress because it is released in response to stress). Symptoms include weight loss, muscle weakness, fatigue, low blood pressure and sometimes browning of the skin. Adrenal insufficiency may require lifelong treatment to replace cortisol deficiency.
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 - Hydrocortisone used?
Plenadren tablets should be taken once a day early in the morning, swallowed whole with a glass of water at least 30 minutes before a meal. The daily dosage is generally between 20 and 30 mg, but this must be individually adjusted according to the patient's reaction. In situations of excessive physical or mental stress or illness, patients may need additional doses of hydrocortisone. In these cases, Plenadren tablets can be administered two or three times a day or it is possible to use immediate-release tablets or injections, either alone or in combination with Plenadren.
How does Plenadren - Hydrocortisone 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 missing in patients suffering from adrenal insufficiency. It has been used in drugs for several decades.
Since it is available as modified-release tablets, Plenadren releases hydrocortisone for a longer period of time, thus allowing it to be taken once a day. It should be taken early in the morning as the amount of cortisol in the blood normally increases early in the morning in healthy people.
What studies have been carried out on Plenadren - Hydrocortisone?
The applicant presented data on experimental models derived from the scientific literature.
The effects of Plenadren were studied in one main study involving 64 patients suffering from adrenal insufficiency. Plenadren, given once a day, has been compared with conventional hydrocortisone treatment which is given three times a day. The study observed cortisol levels in the patients' blood over a 24-hour period after three months of treatment.
What benefit has Plenadren - Hydrocortisone shown during the studies?
In patients taking Plenadren the cortisol levels achieved were considered satisfactory for patients suffering from adrenal insufficiency. The overall amount of cortisol absorbed in the blood was 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatments.
What is the risk associated with Plenadren - Hydrocortisone?
The most common side effect with Plenadren (seen in more than 1 patient in 10) is fatigue. For the full list of all side effects reported with Plenadren, see the Package Leaflet.
Plenadren should not be used in people who may be hypersensitive (allergic) to hydrocortisone or any other ingredient in the medicine.
Why has Plenadren - Hydrocortisone been approved?
The CHMP noted that Plenadren has achieved satisfactory levels of cortisol during the treatment of patients with adrenal insufficiency. The committee also noted the practical aspect of the dosage for taking Plenadren once a day. Although with the once-a-day dosage there is a risk that cortisol levels will drop too much in the afternoon, this problem can be addressed by adding additional doses of hydrocortisone if necessary.
The CHMP concluded that Plenadren's benefits are greater than its risks and recommended that it be given marketing authorization.
More information about Plenadren - Hydrocortisone
On 3 November 2011, the European Commission issued a marketing authorization for Plenadren, valid throughout the European Union.
For more information about Plenadren therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 08/2011.
