Abilify Maintena - aripiprazole

What is Abilify Maintena - aripiprazole and what is it 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 oral aripiprazole therapy. Schizophrenia is a mental illness characterized by a number of symptoms, including thought and speech disorders, hallucinations (seeing or hearing things that are not there), suspiciousness and delusions (false beliefs).

How is Abilify Maintena used - aripiprazole?

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

The medicine can only be obtained with a prescription.

How does Abilify Maintena work - aripiprazole?

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 the nerve cells of the brain, thus interrupting the transmission of signals between the cells of the brain 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 the neurotransmitter dopamine and 5-hydroxytryptamine (also called serotonin) receptors. It acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less vigorously than these neurotransmitters. Since dopamine and 5-hydroxytryptamine are implicated in schizophrenia, aripiprazole contributes to normalization of brain activity, reducing psychotic symptoms and preventing their recurrence.

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 symptoms of schizophrenia from returning. In one main study involving adults in which their disease had already been stabilized by treatment with oral aripiprazole, symptoms returned within 26 weeks in 22 out 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 with Abilify Maintena (which may affect 5 or more in 100 people) are weight gain, akathisia (a state of motor restlessness), insomnia and pain at the injection site. For the full list of 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 monthly administration of the medicinal product could facilitate patients' adherence to the 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 added to the summary of product characteristics and package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients.

More information about Abilify Maintena - aripiprazole

On 15 November 2013, the European Commission granted a "Marketing Authorization" for Abilify Maintena, valid throughout the European Union. For more information on Abilify Maintena therapy, read the package leaflet (included with the EPAR) or consult your doctor or pharmacist. Last update of this summary: 02-2015.

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