What is Abilify Maintena?

Abilify Maintena (aripiprazole) extended-release injection is used alone or in combination with other aripiprazole preparations to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Abilify Maintena injection is also used for the ongoing treatment of people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods)

Abilify Maintena belongs to a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Abilify Maintena is an extended-release injectable suspension given once a month. 

Abilify Maintena side effects

Common Abilify Maintena side effects

Common Abilify Maintena side effects may include:

• Increase in weight 17%
• An inability to remain still (akathisia) 11%
• Constipation 10%
• Injection site pain 5%
• Sedation 5%
• Dry mouth 4%
• Upper respiratory tract infection 4%
• Decrease in weight 4%
• Dizziness 4%
• Diarrhea 3%
• Vomiting 3%
• Muscle and joint pain 3%
• Tremor 3%
• Abdominal discomfort 2%
• Nasal congestion 2%.

These common side effects occured in 2% or more of patient treated with Abilify Mantena over a 12 week clinical trial that was double-blind and placebo-controlled Trial.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder  (tardive dyskinesia) that may not be reversible. The longer you use Abilify Maintena, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Abilify Maintena may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abilify Maintena is not approved for use in older adults with psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Abilify Maintena if you are allergic to aripiprazole.

Tell your doctor if you have never taken Abilify Maintena.

Abilify Maintena may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Maintena is safe for you, tell your doctor if you have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

How is Abilify Maintena given?

Abilify Maintena is injected into a muscle once a month by your healthcare provider.

Your doctor may occasionally change your dose and dosing schedule.

If you have never used Abilify Maintena, you may need to take aripiprazole by mouth (in tablet or liquid form) before you receive your first injection.

You will need to continue taking aripiprazole by mouth for 14 days after your first injection. Follow your doctor’s dosing instructions very carefully.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Use Abilify Maintena as prescribed by your doctor. If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

Abilify Maintena Dosing Information

Usual Adult Abilify Maintena Dose for Schizophrenia:

Initial dose: Abilify Maintena 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection.

General dosing information for schizophrenia

• Before starting therapy with extended-release IM formulations, tolerability should be established with oral formulations; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
• The first dose of the extended-release IM formulation should be given on the same day as the initiation/re-initiation dose; providers should avoid injecting both formulations in the same deltoid or gluteal muscle.
• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses.

Usual Adult Abilify Maintena Dose for Bipolar Disorder:

Initial dose: 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection

General dosing information for bipolar disorder

• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; healthcare providers should periodically reassess need for maintenance treatment.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

If you miss the second or third doses, and:

• if more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 5 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

If the fourth or subsequent doses are missed:

• if more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 6 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

Abilify Maintena Copay card

With the Abilify Maintena Copay Card ,you may pay as little as $10 a month. The Abilify Maintena Copay CardCopay Card helps you save money on prescriptions with an annual maximum benefit of $8,000 and a monthly $1,400 maximum. 

Who is eligible for the Abilify Maintena Copay Card?

You are eligible for the Abilify Maintena Copay Card if you have commercial or private insurance, a valid prescription, and live in the United States and Puerto Rico.  You are not eligible for the Copay Card if you are under 18 years of age, or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE.

How do I apply for the copay card?

You can apply for the Abilify Maintena Copay Card online;

What should I avoid while receiving Abilify Maintena?

Avoid getting up too fast from a sitting or lying position, as this may cause dizziness. Also, avoid driving or engaging in hazardous activities until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Drink plenty of fluids while receiving Abilify Maintena to avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect this medicine?

Sometimes it is not safe to use certain medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Abilify Maintena, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may interact with aripiprazole. Not all possible drug interactions are listed here. To check for drug interactions see Abilify Maintena Interactions.

Does Abilify Maintena interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Abilify Maintena Package Insert

Review the Abilify Maintena Package Insert for more detailed information about this medicine. The Abilify Maintena Package Insert (PI) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more.

Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Abilify Maintena Prescribing Information or FDA label.

Ingredients

Active ingredient: aripiprazole monohydrate.
Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide.

What is Abilify Asimtufii?

Abilify Asimtufii is an atypical antipsychotic used for schizophrenia and bipolar I disorder in adults, Abilify Asimtufii is an extended-release injection that is given once every two months.

The exact way in which  Abilify Asimtufii works (mechanism of action) to treat schizophrenia and bipolar I disorder is not known, but it is thought to work by balancing the levels of serotonin and dopamine in the brain.

Abilify (aripiprazole) is also available as Abilify (oral tablets), Abilify MyCite (tablet embedded with an ingestible sensor), and Abilify Maintena (extended-release injection for administration once every month). 

Abilify Asimtufii is a longer-acting slow-release injection that is given every two months, this helps compliance and means patients only need 6 injections per year.

What is Abilify Asimtufii used to treat?

Abilify Asimtufii is an FDA-approved medicine used for the treatment of schizophrenia in adults, and is used alone (monotherapy) as maintenance treatment of bipolar I disorder in adults.

Schizophrenia is a mental illness characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions.

Bipolar I disorder is a mental illness that characterized by unusual shifts in a person’s mood, energy, activity levels, and concentration.

Patients who have schizophrenia or bipolar I disorder require long-term treatment.

Warnings

Abilify Asimtufii is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior or thoughts about suicide.

Do not stop using aripiprazole suddenly, or you could have unpleasant withdrawal symptoms.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how aripiprazole affects you.

High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

Before taking this medicine

You should not take this medicine if you are allergic to the active ingredient aripiprazole or any of the inactive ingredients. 
This medicine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Asimtufii is safe for you, tell your doctor if you have:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• seizures; or
• low white blood cell (WBC) counts.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

This medicine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. Receiving this medicine during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you receive this medicine during pregnancy. Do not stop the medicine without your doctor’s advice.

Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment. If you become pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. This medicine can pass into your breast milk, and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment.

Abilify Asimtufii pregnancy and breastfeeding warnings (more detail)

How is Abilify Asimtufii given?

For patients who have never taken aripiprazole you must first check their tolerability with oral aripiprazole prior to initiating treatment with this injection. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

Abilify Asimtufii must be given injection given into your buttock muscles by your healthcare provider. Do not administer by any other route.

Abilify Asimtufii is given one time every 2 months.

Patients Receiving Oral Antipsychotics

When Abilify Asimtufii injection is initiated in patients receiving oral aripiprazole, administer the first dose of Abilify Asimtufii along with oral aripiprazole (10 mg to 20 mg) for 14 consecutive days.

For patients already stable on another oral antipsychotic (and known to tolerate aripiprazole), administer the first Abilify Asimtufii injection along with the oral antipsychotic for 14 consecutive days.

Patients Receiving Abilify Maintena

For patients receiving Abilify Maintena (once monthly dosing), administer Abilify Asimtufii 960 mg (once every 2 month dosing) in place of the next scheduled injection of the Abilify Maintena. The first Abilify Asimtufii injection may be administered in place of the second, or later injection of Abilify Maintena.

If there are adverse reactions with the 960 mg dosage, the dosage may be reduced to 720 mg once every 2 months.

Patients may be given the Abilify Asimtufii injection up to 2 weeks before or 2 weeks after the 2-month scheduled timepoint.

Dosing information

Usual Abilify Asimtufii Adult Dose for Schizophrenia

Dose: 960 mg administered once every 2 months as a single injection.

Use: for the treatment of schizophrenia in adults.

Comments:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. 
• Do not administer by any other route.

Usual Abilify Asimtufii Adult Dose for Bipolar I Disorder

Dose: 960 mg administered once every 2 months as a single injection. 

Use: maintenance monotherapy treatment of bipolar I disorder in adults.

Comments:

• Dose can be reduced to 720 mg in patients with adverse reactions.
• For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment.
• Administer by intramuscular injection in the gluteal muscle by a healthcare professional. Do not administer by any other route.

Detailed Abilify Asimtufii dosage information

What happens if I miss a dose?

If more than 8 weeks and less than 14 weeks have elapsed since the last injection, administer the next dose as soon as possible. The once every 2 month schedule should be resumed.

If more than 14 weeks have elapsed since the last injection, restart concomitant oral aripiprazole for 14 days with the next administered injection.

What should I avoid while taking this medicine

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how aripiprazole will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drive a car, operate machinery, or do other dangerous activities until you know how this injection affects you. This medicine may affect your judgement, thinking or motor skills.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking aripiprazole, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Abilify Asimtufii side effects

Get emergency medical help if you have signs of an allergic reaction to aripiprazole: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.

Common Abilify Asimtufii side effects may include:

• blurred vision;
• increased saliva or drooling;
• muscle stiffness;
• uncontrolled muscle movements, shaking, anxiety, feeling restless;
• weight gain;
• nausea, vomiting, constipation;
• increased or decreased appetite;
• headache, dizziness, drowsiness, feeling tired;
• sleep problems (insomnia); or
• cold symptoms such as stuffy nose, sneezing, sore throat;

What is Abilify MyCite Starter Kit?

Abilify MyCite Starter Kit is an antipsychotic medicine that is used to treat adults with schizophrenia.

Abilify MyCite Starter Kit is used alone or with a mood stabilizer medicine to treat adults with bipolar I disorder (manic depression).

Abilify MyCite Starter Kit is used with antidepressant medication to treat major depressive disorder in adults.

Abilify MyCite Starter Kit may also be used for purposes not listed in this medication guide.

Abilify MyCite Starter Kit side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Abilify MyCite Starter Kit may cause serious side effects. Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;
• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;
• mask-like appearance of the face, trouble swallowing, problems with speech;
• seizure (convulsions);
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts–fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Abilify MyCite Starter Kit. Talk with your doctor if this occurs.

Common side effects of Abilify MyCite Starter Kit may include:

• feeling shaky, anxious, or restless;
• nausea, constipation;
• dizziness, drowsiness; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abilify MyCite Starter Kit is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Before taking this medicine

You should not use Abilify MyCite Starter Kit if you are allergic to it.

Abilify MyCite Starter Kit may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems or a stroke;
• high or low blood pressure;
• diabetes (in you or a family member);
• low white blood cell (WBC) counts;
• seizures; or
• trouble swallowing.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Abilify MyCite Starter Kit can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using Abilify MyCite Starter Kit.

How should I take Abilify MyCite Starter Kit?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Abilify MyCite is a drug and device system that has 4 parts:

• A MyCite tablet with a sensor inside it.
• A MyCite Patch (to wear on your skin) that detects a signal from the sensor in the tablet after you take it, and sends this information to a smartphone.
• A Mycite App (a smartphone app) that records when you took the tablet, and tracks information about your activity, sleep, and mood.
• An online portal to share information from the MyCite App with your healthcare providers.

The Mycite Patch usually detects a tablet within 30 minutes after you take it. If the tablet is not detected, do not repeat the dose.

It may take up to 2 hours or longer for the smartphone app and online portal to detect that you’ve taken a tablet.

You may take Abilify MyCite Starter Kit with or without food.

Your doctor will need to check your progress on a regular basis.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

What should I avoid while taking Abilify MyCite Starter Kit?

Avoid driving or hazardous activity until you know how Abilify MyCite Starter Kit will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

While you are taking Abilify MyCite Starter Kit, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

What other drugs will affect Abilify MyCite Starter Kit?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect Abilify MyCite Starter Kit, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

What is Abilify Maintena Prefilled Syringe?

Abilify Maintena and Abilify Asimtufii are used in adults to treat schizophrenia and bipolar disorder.

Aristada is used in adults to treat schizophrenia.

Aristada Initio is used together with oral Abilify Maintena Prefilled Syringe to start or restart Aristada.

Abilify Maintena Prefilled Syringe may also be used for purposes not listed in this medication guide.

Abilify Maintena Prefilled Syringe side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use Abilify Maintena Prefilled Syringe, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using Abilify Maintena Prefilled Syringe. Talk with your doctor if this occurs.

Abilify Maintena Prefilled Syringe may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection–fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar–increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects of Abilify Maintena Prefilled Syringe may include:

• feeling restless;
• pain where the medicine was injected;
• weight gain; or
• drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Abilify Maintena Prefilled Syringe is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Abilify Maintena Prefilled Syringe if you are allergic to it.

Tell your doctor if you have never taken Abilify Maintena Prefilled Syringe.

Abilify Maintena Prefilled Syringe may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have or have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using Abilify Maintena Prefilled Syringe.

How is Abilify Maintena Prefilled Syringe given?

If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

If you have never used Abilify Maintena Prefilled Syringe, you may need to take this medicine by mouth (in tablet or liquid form) before you receive your first injection.

You may need to continue taking Abilify Maintena Prefilled Syringe by mouth for up to 3 weeks after your first injection. Follow your doctor’s dosing instructions very carefully.

Abilify Maintena Prefilled Syringe is injected into a muscle. A healthcare provider will give you this injection once every 4 to 8 weeks. Your doctor may occasionally change your dose and dosing schedule.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Abilify Maintena Prefilled Syringe.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

What should I avoid while receiving Abilify Maintena Prefilled Syringe?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how Abilify Maintena Prefilled Syringe will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are receiving Abilify Maintena Prefilled Syringe.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect Abilify Maintena Prefilled Syringe?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Abilify Maintena Prefilled Syringe, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

What is Abilify Maintena?

Abilify Maintena (aripiprazole) extended-release injection is used alone or in combination with other aripiprazole preparations to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Abilify Maintena injection is also used for the ongoing treatment of people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods)

Abilify Maintena belongs to a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Abilify Maintena is an extended-release injectable suspension given once a month. 

Abilify Maintena side effects

Common Abilify Maintena side effects

Common Abilify Maintena side effects may include:

• Increase in weight 17%
• An inability to remain still (akathisia) 11%
• Constipation 10%
• Injection site pain 5%
• Sedation 5%
• Dry mouth 4%
• Upper respiratory tract infection 4%
• Decrease in weight 4%
• Dizziness 4%
• Diarrhea 3%
• Vomiting 3%
• Muscle and joint pain 3%
• Tremor 3%
• Abdominal discomfort 2%
• Nasal congestion 2%.

These common side effects occured in 2% or more of patient treated with Abilify Mantena over a 12 week clinical trial that was double-blind and placebo-controlled Trial.

Serious side effects

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

High doses or long-term use of aripiprazole can cause a serious movement disorder  (tardive dyskinesia) that may not be reversible. The longer you use Abilify Maintena, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Abilify Maintena may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Abilify Maintena side effects (more detail)

Warnings

Abilify Maintena is not approved for use in older adults with psychotic conditions related to dementia. Aripiprazole may increase the risk of death in older adults with dementia-related psychosis.

Before taking this medicine

You should not be treated with Abilify Maintena if you are allergic to aripiprazole.

Tell your doctor if you have never taken Abilify Maintena.

Abilify Maintena may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Abilify Maintena is safe for you, tell your doctor if you have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor’s advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Abilify Maintena pregnancy and breastfeeding warnings (more detail)

How is Abilify Maintena given?

Abilify Maintena is injected into a muscle once a month by your healthcare provider.

Your doctor may occasionally change your dose and dosing schedule.

If you have never used Abilify Maintena, you may need to take aripiprazole by mouth (in tablet or liquid form) before you receive your first injection.

You will need to continue taking aripiprazole by mouth for 14 days after your first injection. Follow your doctor’s dosing instructions very carefully.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Use Abilify Maintena as prescribed by your doctor. If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor’s advice.

Abilify Maintena Dosing Information

Usual Adult Abilify Maintena Dose for Schizophrenia:

Initial dose: Abilify Maintena 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection.

General dosing information for schizophrenia

• Before starting therapy with extended-release IM formulations, tolerability should be established with oral formulations; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
• The first dose of the extended-release IM formulation should be given on the same day as the initiation/re-initiation dose; providers should avoid injecting both formulations in the same deltoid or gluteal muscle.
• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses.

Usual Adult Abilify Maintena Dose for Bipolar Disorder:

Initial dose: 400 mg IM once; continue aripiprazole IR 10 to 20 mg orally once a day for 14 days
Maintenance dose: 300 to 400 mg IM once a month; the dose should not be given sooner than 26 days after the previous injection

General dosing information for bipolar disorder

• For patients who experience adverse reactions with 400 mg/month extended-release IM suspension doses your doctor may consider reducing the dose to 300 mg/month.
• The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; healthcare providers should periodically reassess need for maintenance treatment.

Detailed Abilify Maintena dosage information

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

If you miss the second or third doses, and:

• if more than 4 weeks and less than 5 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 5 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

If the fourth or subsequent doses are missed:

• if more than 4 weeks and less than 6 weeks have elapsed since the last injection, administer the injection as soon as possible.
• if more than 6 weeks have elapsed since the last injection, restart and also take oral aripiprazole for 14 days with the next administered injection.

What happens if I overdose?

Seek emergency medical attention

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

Abilify Maintena Copay card

With the Abilify Maintena Copay Card ,you may pay as little as $10 a month. The Abilify Maintena Copay CardCopay Card helps you save money on prescriptions with an annual maximum benefit of $8,000 and a monthly $1,400 maximum. 

Who is eligible for the Abilify Maintena Copay Card?

You are eligible for the Abilify Maintena Copay Card if you have commercial or private insurance, a valid prescription, and live in the United States and Puerto Rico.  You are not eligible for the Copay Card if you are under 18 years of age, or are covered in whole or in part by any state program or federal healthcare program, including, but not limited to, Medicare or Medicaid (including Medicaid managed care), Medigap, VA, DOD, or TRICARE.

How do I apply for the copay card?

You can apply for the Abilify Maintena Copay Card online; a link is on the Abilify Maintena Price Guide page.

What should I avoid while receiving Abilify Maintena?

Avoid getting up too fast from a sitting or lying position, as this may cause dizziness. Also, avoid driving or engaging in hazardous activities until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Drink plenty of fluids while receiving Abilify Maintena to avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect this medicine?

Sometimes it is not safe to use certain medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Abilify Maintena, especially:

• blood pressure medications;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• bronchodilator asthma medication;
• cold or allergy medicine (Benadryl and others);
• medicine to treat overactive bladder;
• medicine to treat Parkinson’s disease; or
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may interact with aripiprazole. Not all possible drug interactions are listed here. To check for drug interactions see Abilify Maintena Interactions.

Abilify Maintena drug interactions (more detail)

Does Abilify Maintena interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Abilify Maintena Package Insert

Review the Abilify Maintena Package Insert for more detailed information about this medicine. The Abilify Maintena Package Insert (PI) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more.

Discuss any medical questions with your doctor or other health care provider. This is not all the information you need about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Abilify Maintena Prescribing Information or FDA label.

Ingredients

Active ingredient: aripiprazole monohydrate.
Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide.