Aripiprazole

Aripiprazole is a prescription medication used to treat schizophrenia, bipolar disorder, and autism. It can also be used in combination with an antidepressant to treat depression. Aripiprazole 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 comes as a tablet, as an orally disintegrating tablet, a tablet with an Ingestible Event Marker (IEM) sensor, and in oral solution form and is usually taken once a day, with or without food.

This medication is also available in immediate and extended-release injectable forms to be given directly into the muscle (IM) by a healthcare professional.

The extended-release injectable form is approved to treat symptoms of schizophrenia and is also approved for acute schizophrenia relapse in adults.

Common side effects of aripiprazole include insomnia, fatigue, and an inner sense of restlessness or need to move.

CYP2D6 is a protein in your body that is involved in the elimination of aripiprazole and other drugs from your body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2D6 can vary greatly between individuals, and those having less of this protein are known as "poor metabolizers." 

CYP2D6 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of aripiprazole in your blood can become too high. As a result you may be at an increased risk of having more side effects from aripiprazole.

Your doctor may adjust your dose of aripiprazole if you are a poor metabolizer.

Oral and Immediate-Release Injectable:

Aripiprazole is a prescription medication used to treat:

• schizophrenia in people age 13 years and older
• bipolar I disorder in people age 10 years and older, including:
  • manic or mixed episodes that happen with bipolar I disorder
  • manic or mixed episodes that happen with bipolar I disorder when used with the medicine lithium or valproate
  • long-term treatment of bipolar I disorder
• major depression in adults, as an add-on treatment to an antidepressant medicine, when you do not get better with an antidepressant alone
• irritability associated with autistic disorder in children and adolescents ages 6 to 17 years old
• agitation associated with schizophrenia or bipolar disorder

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

Oral tablet with sensor:

Aripiprazole tablet with a sensor is a prescription medication used to treat:

• adults with schizophrenia
• bipolar I disorder in adults, including:
  • the short-term treatment of manic or mixed episodes. May be used alone or with the medicine lithium or valproate.
  • long-term treatment of bipolar I disorder. May be used alone or with the medicine lithium or valproate.
• major depression in adults, as an add-on treatment to an antidepressant medicine, when you do not get better with an antidepressant alone

Extended-Release Injectable:

• Aripiprazole extended-release injectable is a prescription medication used to treat adults with schizophrenia as well as used to treat adults with bipolar I disorder.

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

Aripiprazole may be found in some form under the following brand names:

• Abilify

• Abilify Discmelt

• Abilify Maintena

• Abilify MyCite

Oral tablet, oral tablet with sensor, and immediate-release injectable:

Common side effects in adults include the following:

• nausea
• vomiting
• constipation
• headache
• dizziness
• an inner sense of restlessness/the need to move (akathisia)
• anxiety
• insomnia
• restlessness
• pain at the injection site

Common side effects in children include the following:

• sleepiness
• headache
• vomiting
• tiredness
• increased appetite
• insomnia
• nausea
• stuffy nose
• weight gain
• uncontrolled movement (restlessness, tremor, muscle stiffness)
• pain at injection site

Extended-Release Injectable:

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

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

Serious side effects have been reported with aripiprazole. See "Aripiprazole Precautions" 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
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort

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

Serious side effects have been reported with aripiprazole 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 aripiprazole. Call your healthcare provider if you have any of these symptoms of high blood sugar while taking aripiprazole:
    • 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 aripiprazole, 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 aripiprazole. Tardive dyskinesia may also start after you stop taking aripiprazole.
• 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 aripiprazole.
• Increased risk of death in elderly people with dementia-related psychosis. This medication 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 aripiprazole affects you. Aripiprazole may make you drowsy. Do not drink alcohol while taking aripiprazole.

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

Before you receive aripiprazole, 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 aripiprazole 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 aripiprazole will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Aripiprazole 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 aripiprazole.

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.

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

Oral:

• Take aripiprazole exactly as prescribed. Do not change the dose or stop taking aripiprazole without talking to your doctor.
• Aripiprazole can be taken with or without food.
• Swallow aripiprazole tablets whole.
• If you miss a dose of aripiprazole, take it as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of aripiprazole at the same time.
• If you have been prescribed aripiprazole disintegrating tablets, take it as follows:
  • Do not open the blister until ready to take the orally disintegrating tablet.
  • To remove one tablet, open the package and peel back the foil on the blister to expose the tablet.
  • Do not push the tablet through the foil because this could damage the tablet.
  • Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orally disintegrating tablet on the tongue.
  • Tablet disintegration occurs rapidly in saliva. It is recommended it be taken without liquid. However, if needed, it can be taken with liquid.
  • Do not attempt to split the orally disintegrating tablet.

Oral tablet with sensor:

• Take aripiprazole with sensor exactly as prescribed. 
• Aripiprazole with sensor comes in tablet form and is taken once a day. Take with or without food.
• Do not chew, divide, or break aripiprazole with sensor tablets. Swallow tablets whole.
• Follow your healthcare provider's instructions on how to apply and wear the sensor patch. The sensor patch should be placed on the left side of the body just above the lower edge of the rib cage. Do not place the sensor patch on skin that is cracked, scraped, or irritated. The sensor patch should be kept on when showering, swimming, or exercising and replaced weekly or sooner.
• The aripiprazole with sensor tablet is usually detected by the sensor patch within 30 minutes after you take it, but there can be a delay of more than 2 hours for the sensor app and portal to have the information. Sometimes the aripiprazole with sensor tablet is not detected. If the tablet is not detected after you take it, do not repeat the dose.
• Do not stop or change the way you take aripiprazole with sensor tablet without talking to your healthcare provider.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of aripiprazole with sensor tablet at the same time.

Immediate-Release Injectable:

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

Extended-release injectable:

• 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 aripiprazole exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The recommended dose varies depending upon which condition is being treated as well as other factors.

Aripiprazole tablets and oral solution

• The recommended dose range for aripiprazole (Abilify) is 5 mg -15 mg per day. The maximum dose per day is 30 mg.
• The target dose for adolescents is 10 mg/day.
• Your doctor will start you on a smaller dose and then increase the dose to a target dose.

Aripiprazole immediate-release injection

• The recommended dose is 9.75 mg injected into the muscle (IM) once. If another dose is needed, the second dose can be administered 2 hours later. The maximum dose of aripiprazole (Abilify) per day is 30 mg.

Aripiprazole orally disintegrating tablet

• The recommended dose of aripiprazole orally disintegrating tablet (Abilify Discmelt) is 10 mg or 15 mg by mouth daily. The target dose for adolescents is 10 mg/day.
• The dose may be increased to a maximum of 30 mg daily after 2 weeks.

Aripiprazole extended-release injection

• 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 first dose, take 14 consecutive days of concurrent oral aripiprazole (10 mg to 20 mg) or current oral antipsychotic.
• 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.

Aripiprazole with Ingestible Event Marker (IEM) sensor

• The recommended dose range of Abilify MyCite for schizophrenia and in bipolar I disorder is 10 mg to 15 mg. The maximum dose per day is 30 mg.
• The recommended dose range of Abilify MyCite for depression with an antidepressant is 2 mg to 5 mg. The maximum dose per day is 15 mg.

If you take too much aripiprazole call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If aripiprazole 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.

• Store aripiprazole at room temperature.
• Opened bottles of aripiprazole oral solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle.
• Keep aripiprazole and all medicines out of the reach of children.

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. Aripiprazole 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 aripiprazole 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. Aripiprazole is not approved for use in pediatric patients with depression.