This is a summary of the European public assessment report (EPAR) for Abilify Maintena. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Abilify Maintena.
For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist.
- What is Abilify Maintena and what is it used for?
Abilify Maintena is a medicine that contains the active substance aripiprazole. It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with aripiprazole taken by mouth.
Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
- How is Abilify Maintena used?
Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection. ‘Prolonged release’ means that the active substance is released slowly over a few weeks after being injected. The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse. It must not be injected into a vein or under the skin.
The recommended dose is 400 mg once a month. In case of side effects, the dose may be reduced to 300 mg. The dose may also need to be lowered in patients who are taking certain other medicines that slow the breakdown of aripiprazole in the body. Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided. After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks.
The medicine can only be obtained with a prescription.
- How does Abilify Maintena work?
The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine. Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain. This disrupts signals transmitted between brain cells by ‘neurotransmitters’, chemicals that allow nerve cells to communicate with each other.
Aripiprazole is thought to act mainly by being a ‘partial agonist’ for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin). This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters. Since dopamine and 5-hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.
- What benefits of Abilify Maintena have been shown in studies?
Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning. In one main study involving adults whose disease had already been stabilised on treatment with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.
- What are the risks associated with Abilify Maintena?
The most common side effects with Abilify Maintena (which may 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain. For the full list of all side effects reported with Abilify Maintena, see the package leaflet.
- Why is Abilify Maintena approved?
The Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena’s benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable. The Committee considered that the monthly administration may help patients to adhere to their treatment.
- What measures are being taken to ensure the safe and effective use of Abilify Maintena?
A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients.
- Other information about Abilify Maintena
The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013.
For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This EPAR was last updated on 25/05/2016 .
28/04/2016 Abilify Maintena -EMEA/H/C/002755 -PSUSA/234/201507
- 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.
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Changes since initial authorisation of medicine
|Name||Language||First published||Last updated|
|Abilify Maintena : EPAR - Procedural steps taken and scientific information after authorisation||HR = Hrvatski||08/04/2014||25/05/2016|
|Abilify Maintena-H-C-PSUSA-00000234-201507 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)||HR = Hrvatski||25/05/2016|
|Abilify Maintena-H-C-PSUSA-0234-201407 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation||HR = Hrvatski||02/06/2015|
Initial marketing-authorisation documents
|Name||Language||First published||Last updated|
|Abilify Maintena : EPAR - Public assessment report||HR = Hrvatski||28/11/2013|
|CHMP summary of positive opinion for Abilify Maintena||HR = Hrvatski||20/09/2013|
This medicine is approved for use in the European Union