Abilify Maintena - aripiprazole

What is Abilify Maintena - aripiprazole used for?

Abilify Maintena is a medicine that contains the active substance aripiprazole . It is indicated for the maintenance therapy of schizophrenia in adults whose condition has already been stabilized with an oral aripiprazole therapy. Schizophrenia is a mental illness characterized by a series of symptoms, including thought and speech disorders, hallucinations (seeing or hearing non-existent things), suspiciousness and fixations (false beliefs).

How is Abilify Maintena - aripiprazole used?

Abilify Maintena is available as a powder (300 mg and 400 mg) and a solvent to be reconstituted in a prolonged release injection solution. The expression "prolonged release" means that the active ingredient is released slowly over a few weeks after the injection. The medicine is given once a month by slow injection into the gluteal muscle or deltoid muscle (shoulder), performed by a doctor or nurse. The medicine should not be administered intravenously or subcutaneously. The recommended dose is 400 mg once a month. In case of side effects, the dose can be reduced to 300 mg. The dose may also be reduced in patients taking some other medicines that slow the breakdown of aripiprazole in the body. Treatment beyond two weeks should be avoided with medicines that accelerate the breakdown of aripiprazole. After the first injection, daily treatment with 10-20 mg of oral aripiprazole should be continued for 2 weeks.

The medicine can only be obtained with a prescription.

How does Abilify Maintena - aripiprazole work?

The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine. Although its exact mechanism of action is not known, it is certain that it binds to receptors present on the surface of nerve cells in the brain, thus interrupting the transmission of signals between brain cells operated by "neurotransmitters", the chemicals that allow nerve cells to communicate with each other. Aripiprazole is believed to act mostly as a "partial agonist" of dopamine and 5-hydroxytryptamine neurotransmitter receptors (also called serotonin). That is, it acts as dopamine and 5-hydroxytryptamine activating these receptors, but less vigorously than these neurotransmitters. Since dopamine and 5-hydroxytryptamine are implicated in schizophrenia, aripiprazole contributes to the normalization of brain activity, reducing psychotic symptoms and preventing its reappearance.

What benefit has Abilify Maintena - aripiprazole shown during the studies?

Abilify Maintena has been shown to be as effective as oral aripiprazole in preventing the reappearance of schizophrenia symptoms. Within one main study involving adults in whom the disease had already been stabilized by oral aripiprazole treatment, symptoms reappeared within 26 weeks in 22 of 265 patients (8.3%) treated with Abilify Maintena compared to 21 of 266 patients (7.9%) treated with oral aripiprazole.

What is the risk associated with Abilify Maintena - aripiprazole?

The most common side effects of Abilify Maintena (which may affect 5 people or more in 100) are weight gain, akathisia (state of motor restlessness), insomnia and pain at the injection site. For the full list of all side effects reported with Abilify Maintena, see the package leaflet.

Why has Abilify Maintena - aripiprazole been 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 oral aripiprazole and has a similar safety profile, except for pain at the injection site, which is considered manageable. The committee considered that the monthly administration of the medicine may facilitate patient compliance with the treatment regimen.

What information is still awaited for Abilify Maintena - aripiprazole?

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 on Abilify Maintena - aripiprazole

On 15 November 2013, the European Commission issued a marketing authorization for Abilify Maintena, valid throughout the European Union. For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 02-2015.

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