Giapreza
Authorised
This medicine is authorised for use in the European Union
angiotensin II
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Giapreza is a medicine used in adults with dangerously low blood pressure (a condition known as shock).
It is used when other treatments for raising blood pressure have not worked and contains the active substance angiotensin II.
The medicine should be prescribed by a physician experienced in the treatment of shock and is for use in a hospital setting. It is given as a continuous infusion (‘drip’) into a vein. The dose depends on the patient’s weight and should be adjusted according to the patient’s blood pressure.
For more information about using Giapreza, see the package leaflet or contact your doctor or pharmacist.
The active substance in Giapreza, angiotensin II, is the same as a hormone that the body produces. Angiotensin II increases blood pressure by narrowing blood vessels and releasing another hormone (aldosterone) that increases the volume of blood circulating in the body.
A main study involving 344 patients in shock has shown that Giapreza is effective at raising blood pressure when other treatments have not worked. After 3 hours, 70% of patients treated with Giapreza in addition to standard treatments had their average arterial blood pressure rise to above 75 mmHg (an acceptable level) or by at least 10 mmHg, compared with 23% of patients treated with placebo (a dummy treatment) and standard treatments.
The most common side effects with Giapreza (which may affect more than 1 in 10 people) are thromboembolic events (problems due to clots in blood vessels) and short-lived high blood pressure.
For the full list of side effects and restrictions with Giapreza, see the package leaflet.
The main study showed that adding Giapreza to standard treatment was effective in increasing average blood pressure in patients in shock. The rise in blood pressure is expected to help prevent organ damage and reduce the number of deaths from this condition. The side effects of Giapreza were similar to those of standard treatments and were considered manageable. The European Medicines Agency therefore decided that Giapreza’s benefits are greater than its risks and that it can be authorised for use in the EU.
The company that markets Giapreza will carry out a study to further investigate the effectiveness and safety of Giapreza, including whether the medicine could prevent damage to organs and affect how long patients live.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Giapreza have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Giapreza are continuously monitored. Side effects reported with Giapreza are carefully evaluated and any necessary action taken to protect patients.
Giapreza received a marketing authorisation valid throughout the EU on 23 August 2019.
Product information
Latest procedure affecting product information:
T/0031
19/09/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Giapreza
- Active substance
- Angiotensin II acetate
- International non-proprietary name (INN) or common name
- angiotensin II
- Therapeutic area (MeSH)
- Hypotension
- Shock
- Anatomical therapeutic chemical (ATC) code
- C09
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic indication
Giapreza is indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies.
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