What is Abilify Maintena?

Abilify Maintena is a brand name for the drug aripiprazole that Otsuka America Pharmaceutical, Inc manufactures. This aripiprazole formulation is an extended-release injection used alone or in combination with other medicines for the treatment of schizophrenia and maintenance monotherapy of bipolar I disorder. It belongs to the class of medications known as atypical antipsychotics. Abilify Maintena can help decrease hallucinations (hearing or seeing things that aren’t there) and improve your concentration.

How does Abilify Maintena work?

Abilify Maintena is an intramuscular injection that changes the activity levels of natural substances in the brain. It is not entirely clear how Abilify Maintena works, but the rebalancing of dopamine and serotonin is thought to contribute to its effects.

What doses of Abilify Maintena are available?

Abilify Maintena is an intramuscular injection that should be given by a healthcare professional. If you have never taken aripiprazole before, you would start with a short-term trial of oral aripiprazole (10mg to 20mg) for up to 14 consecutive days to test your tolerability. If tolerated, your starting dose is a single-dose monthly injection of 400mg. If there are adverse effects, talk to your doctor about considering reducing the dosage to 300mg once monthly.

Doses should be adjusted if you are a CYP2D6 poor metabolizer or have taken a concomitant CYP3A4 inhibitor, CYP3A4 inducer, or CYP2D6 inhibitor for more than 14 days.

How do you use Abilify Maintena?

Talk to your doctor and read all prescribing information and medication guide before you begin treatment with Abilify Maintena. Abilify is a powder that requires reconstitution with water before it can be given.

Before your first shot, you may need to take oral aripiprazole for up to two weeks to test your tolerability. For two weeks after your first injection, you will continue your current oral antipsychotic.

Abilify Maintena is only given by a healthcare professional and is usually given once every four weeks (no sooner than 26 days after the previous injection). Aripiprazole is usually injected into the gluteal muscle (buttocks) or deltoid (arm). If you have a condition like cerebrovascular disease, it will require a different injection site.

It is recommended to mark the days on your calendar so you do not miss your appointment. Adjustments to your treatment plan are required for missed doses. Talk to your doctor as soon as possible if you miss it, as you will probably need to take your oral antipsychotic medication.

What are the side effects of Abilify Maintena?

The most common side effects of Abilify Maintena in clinical trials compared to placebo include:

Akathisia (a constant urge to move)
Injection site pain and other reactions
Weight gain
Constipation
Sedation

Rarely, Abilify Maintena may cause some serious side effects, including:

Higher risk of death in senior citizens with dementia-related psychosis.
The development of neuroleptic malignant syndrome (NMS). Call your healthcare provider if you experience:
- Muscles stiffness
- Fever
- Sweating
- Confusion
- Irregular heartbeat
Significant changes in white blood cell counts

Contact your healthcare professional for medical advice about any possible adverse reactions you experience while taking Abilify Maintena. You can report your adverse events to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Abilify Maintena drug interactions

When Abilify Maintena is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Some drug interactions with Abilify Maintena include:

Alcohol
Angiotensin II receptor blockers (ARBs; e.g., losartan)
Antihistamines (e.g., cetirizine)
Benzodiazepines (e.g. lorazepam)
HIV protease inhibitors (e.g., atazanavir)
MAO inhibitors (e.g., moclobemide)
Methadone
Protein kinase inhibitors (e.g., ceritinib)
Quinidine
Seizure medications (e.g., carbamazepine)
Selective serotonin reuptake inhibitors (SSRIs; e.g., fluoxetine)
Serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine)

Boxed warnings

Senior patients treated for dementia-related psychosis with antipsychotic drugs are at an increased risk of death. It is not approved to treat patients with dementia-related psychosis.

Abilify Maintena precautions and contraindications

You should be sure that your healthcare provider is aware of all your medical conditions, including if you:

Are pregnant or plan on becoming pregnant
Are breastfeeding as a reduced milk supply in lactating women has been found
Are allergic to aripiprazole or any of the ingredients in aripiprazole extended-release injection
Had or have ever had heart disease, a heart attack, stroke, heart failure, high or low blood pressure (orthostatic hypotension), or an irregular heartbeat
Have a history of seizures
Know that you have a low number of white blood cells
Have had dyslipidemia (high cholesterol levels)
Have ever had trouble keeping your balance
Have a family history of diabetes or have risk factors for developing diabetes

Let your doctor know if you experience any of the following symptoms:

Severe diarrhea or vomiting.
Signs of high blood sugar, including extreme thirst, extreme hunger, blurred vision, frequent urination
Signs of neuroleptic malignant syndrome (NMS)
An inability to regulate body temperature. Avoid overheating during strenuous exercise or in hot temperatures as much as possible because this has been related to antipsychotic agents, such as Abilify Maintena.
Signs of tardive dyskinesia, including involuntary, uncontrolled body movements.
Agitated behavior or thoughts of suicide.

Make sure to keep in mind the following:

This long-acting medication may make you drowsy or unable to think clearly. Do not operate a car while first using this medication or until you know how this medication affects you.
You should not drink alcohol during your treatment with aripiprazole.
You may develop hyperglycemia (increases in your blood sugar). In general, people with schizophrenia are more likely to develop diabetes than those who do not. Using aripiprazole extended-release for the maintenance treatment of schizophrenia may increase that risk. If you already have diabetes, make sure to get a baseline test and check for worsening symptoms.
Abilify Maintena has not been tested on anyone younger than 18 years of age.