Generic name: aripiprazole lauroxil (injection) [ AR-i-PIP-ra-zole ]
Drug class: Atypical antipsychotics

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.

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 at 1-800-222-1222.

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 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.

Manufacturer

Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan.

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