Abilify Maintena

Abilify Maintena is a prescription medication used to treat adults with schizophrenia as well as used to treat adults with bipolar I disorder. 

Abilify Maintena belongs to a group of drugs called atypical antipsychotics. These medications work by altering the activity of certain natural substances in the brain.

This medication is available in an extended-release injectable form to be given directly into the muscle (IM) by a healthcare professional once a month.

The most common side effect of Abilify Maintena includes feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia).

Abilify Maintena can cause you to feel very sleepy. Do not drive or operate heavy machinery until you know how Abilify Maintena affects you.

Abilify Maintena is a prescription medication used to treat:

• schizophrenia in adults
• bipolar I disorder in adults

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Otsuka America Pharmaceutical, Inc.

The most common side effect of Abilify Maintena includes:

• feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia)
• weight increase
• injection site pain
• sedation (makes you sleepy)

This is not a complete list of Abilify Maintena side effects. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Abilify Maintena. See "Abilify Maintena" section.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and nonprescription medications, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antidepressants (mood elevators)
• antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• antihistamines
• bupropion (Wellbutrin)
• carbamazepine (Tegretol)
• clarithromycin (Biaxin)
• fluoxetine (Prozac, Sarafem)
• HIV protease inhibitors such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• ipratropium (Atrovent)
• medications for anxiety, high blood pressure, irritable bowel syndrome, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• nefazodone (Serzone)
• paroxetine (Paxil, Pexeva)
• quinidine (Cardioquine, Quinact, Duraquin)
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• telithromycin (Ketek)
• tranquilizers

This is not a complete list of Abilify Maintena drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Abilify Maintena including the following

• Neuroleptic malignant syndrome (NMS). Tell your healthcare provider right away if you have some or all of the following symptoms of this life-threatening nervous system disorder:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure
• Changes in the body's metabolic processes:
  • High blood sugar. Increases in blood sugar can happen in some people who take Abilify Maintena.
    Call your healthcare provider if you have any of these symptoms of high blood sugar while taking Abilify Maintena:
    • feel very thirsty
    • need to urinate more than usual
    • feel very hungry
    • feel weak or tired
    • feel sick to your stomach
    • feel confused, or your breath smells fruity
  • Increase in weight. Weight gain has been reported in patients taking medicines like Abilify Maintena, so you and your healthcare provider should check your weight regularly. For children and adolescent patients (6 to 17 years of age) weight gain should be compared against that expected with normal growth.
  • Increase fat levels (cholesterol and triglycerides in your blood)
• Difficulty swallowing. This may lead to aspiration and choking.
• Tardive dyskinesia. Call your healthcare provider about any movements you cannot control in your face, tongue, or other body parts. These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking Abilify Maintena. Tardive dyskinesia may also start after you stop taking Abilify Maintena.
• Unusual urges. Some people receiving this medication have had unusual urges such as gambling, binge eating or eating that you cannot control (compulsive), compulsive shopping and sexual urges. If you or your family members notice that you are having unusual urges or behaviors, talk to your healthcare provider.
• Orthostatic hypotension (decreased blood pressure). Lightheadedness or fainting can occur when rising too quickly from a sitting or lying position.
• Low white blood cell count
• Seizures (convulsions)
• Problems controlling your body temperature so that you feel too warm. Avoid getting overheated or dehydrated. Do not over-exercise. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much or heavy clothing. Drink plenty of water while taking Abilify Maintena.
• Increased risk of death in elderly people with dementia-related psychosis. Abilify Maintena is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
• Increase risk of falls. 

Important information about antidepressant medicines:

• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
• Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how Abilify Maintena affects you. Abilify Maintena may make you drowsy. Do not drink alcohol while taking Abilify Maintena.

Grapefruit and grapefruit juice may interact with Abilify Maintena and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you receive Abilify Maintena, tell your healthcare provider if you:

• have never taken aripiprazole before
• have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving Abilify Maintena and during your treatment.
• have or had seizures (convulsions)
• have or had low or high blood pressure
• have or had heart problems or a stroke
• have or had a low white blood cell count
• have any other medical problems including problems that may affect you receiving an injection in your buttocks
• are pregnant or plan to become pregnant. It is not known if Abilify Maintena will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Abilify Maintena can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive Abilify Maintena.

Tell your doctor about all the medicines that you take including prescription medicines, non-prescription medicines, herbal supplements, and vitamins.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Abilify Maintena has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Abilify Maintena, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

• Abilify Maintena is given by injection in the buttock by a healthcare provider once a month.
• After your first injection you should continue your current antipsychotic medicine for 2 weeks.
• You should not miss a dose. If you miss a dose, call your healthcare provider right away to discuss what you should do next.

Take Abilify Maintena exactly as prescribed by your doctor.

The recommended starting dose and maintenance dose is 400 mg administered monthly as a single injection. If you have side effects, your dose can be reduced to 300 mg.

In conjunction with the first dose, take 14 consecutive days of concurrent oral Abilify (10 mg to 20 mg) or with the current medication, you are taking by mouth for schizophrenia or bipolar medication.  

Dosage adjustments are required for missed doses.

If you are a known CYP2D6 Poor metabolizer, the recommended starting dose and maintenance dose is 300 mg administered monthly as a single injection.

Since Abilify Maintena is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Talk to your doctor or your pharmacist about the following black box warning for this medication:

WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of adjunctive Abilify Maintena or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Abilify Maintena is not approved for use in pediatric patients with depression.