Abilify Maintena

Name: Abilify Maintena

Commonly used brand name(s)

In the U.S.

  • Abilify
  • Abilify Maintena

Available Dosage Forms:

  • Solution
  • Powder for Suspension, Extended Release

Therapeutic Class: Antipsychotic

Uses of Abilify Maintena

  • It is used to treat schizophrenia.
  • It is used to treat bipolar problems.
  • It may be given to you for other reasons. Talk with the doctor.

Warnings and Precautions

Increased Mortality in Elderly Patients with Dementia- Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 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 (e.g., heart failure, sudden death) or infectious (e.g., 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.

Cerebrovascular Adverse Reactions, Including Stroke in Elderly Patients with Dementia-Related Psychosis

In placebo-controlled clinical studies (two flexible dose and one fixed dose study) of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, in oral aripiprazole-treated patients (mean age: 84 years; range: 78-88 years). In the fixed-dose study, there was a statistically significant dose response relationship for cerebrovascular adverse reactions in patients treated with oral aripiprazole. Abilify Maintena is not approved for the treatment of patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) may occur with administration of antipsychotic drugs, including Abilify Maintena. Rare cases of NMS occurred during aripiprazole treatment in the worldwide clinical database.

Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology.

The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

Tardive Dyskinesia

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and, thereby, may possibly mask the underlying process. The effect of symptomatic suppression on the long-term course of the syndrome is unknown.

Given these considerations, Abilify Maintena should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that 1) is known to respond to antipsychotic drugs and 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient treated with Abilify Maintena drug discontinuation should be considered. However, some patients may require treatment with Abilify Maintena despite the presence of the syndrome.

Metabolic Changes

Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. While all drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile.

Hyperglycemia/Diabetes Mellitus

Hyperglycemia, in some cases extreme and associated with diabetic ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with aripiprazole [see ADVERSE REACTIONS (6.1)]. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. However, epidemiological studies suggest an increased risk of hyperglycemia-related adverse reactions in patients treated with the atypical antipsychotics.

Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes), who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the atypical antipsychotic drug.

In a short-term, placebo-controlled randomized trial in adults with schizophrenia, the mean change in fasting glucose was +9.8 mg/dL (N=88) in the Abilify Maintena-treated patients and +0.7 mg/dL (N=59) in the placebo-treated patients. Table 4 shows the proportion of Abilify Maintena-treated patients with normal and borderline fasting glucose at baseline and their changes in fasting glucose measurements.

Table 4: Proportion of Patients with Potential Clinically Relevant Changes in Fasting Glucose from a 12-Week Placebo-Controlled Monotherapy Trial in Adult Patients with Schizophrenia

Category Change (at least once) from Baseline Treatment Arm n/Na %
a N = the total number of subjects who had a measurement at baseline and at least one post-baseline result.
n = the number of subjects with a potentially clinically relevant shift.

Fasting Glucose

Normal to High
(<100 mg/dL to ≥126 mg/dL)

Abilify Maintena

7/88

8.0

Placebo

0/75

0.0

Borderline to High
(≥100 mg/dL and <126 mg/dL to ≥126 mg/dL)

Abilify Maintena

1/33

3.0

Placebo

3/33

9.1

During a 52-week, open-label bipolar I disorder study in those patients who initiated Abilify Maintena treatment, 1.1% with normal baseline fasting glucose experienced a shift to high while receiving Abilify Maintena and 9.8% with borderline fasting glucose experienced a shift to high. Combined, 2.9% of these patients with normal or borderline fasting glucose experienced shifts to high fasting glucose during this trial.

Dyslipidemia

Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.

Table 5 shows the proportion of adult patients from one short-term, placebo-controlled randomized trial in adults with schizophrenia taking Abilify Maintena, with changes in total cholesterol, fasting triglycerides, fasting LDL cholesterol and HDL cholesterol.

Table 5: Proportion of Patients with Potential Clinically Relevant Changes in Blood Lipid Parameters From a 12-Week Placebo-Controlled Monotherapy Trial in Adults with Schizophrenia

Treatment Arm n/Na %
a N = the total number of subjects who had a measurement at baseline and at least one post-baseline result.
n = the number of subjects with a potentially clinically relevant shift.

Total Cholesterol
Normal to High
(<200 mg/dL to ≥240 mg/dL)

Abilify Maintena

3/83

3.6

Placebo

2/73

2.7

Borderline to High

(200~<240 mg/dL to ≥240 mg/dL)

Abilify Maintena

6/27

22.2

Placebo

2/19

10.5

Any increase

(≥40 mg/dL)

Abilify Maintena

15/122

12.3

Placebo

6/110

5.5

Fasting Triglycerides
Normal to High
(<150 mg/dL to ≥200 mg/dL)

Abilify Maintena

7/98

7.1

Placebo

4/78

5.1

Borderline to High

(150~<200 mg/dL to ≥200 mg/dL)

Abilify Maintena

3/11

27.3

Placebo

4/15

26.7

Any increase

( ≥ 50 mg/dL)

Abilify Maintena

24/122

19.7

Placebo

20/110

18.2

Fasting LDL Cholesterol
Normal to High
(<100 mg/dL to ≥160 mg/dL)

Abilify Maintena

1/59

1.7

Placebo

1/51

2.0

Borderline to High

(100~<160 mg/dL to ≥160 mg/dL)

Abilify Maintena

5/52

9.6

Placebo

1/41

2.4

Any increase

( ≥ 30 mg/dL)

Abilify Maintena

17/120

14.2

Placebo

9/103

8.7

HDL Cholesterol
Normal to Low
(≥40 mg/dL to <40 mg/dL)

Abilify Maintena

14/104

13.5

Placebo

11/87

12.6

Any decrease

( ≥ 20 mg/dL)

Abilify Maintena

7/122

5.7

Placebo

12/110

10.9

During a 52-week, open-label bipolar I disorder study in those patients who initiated Abilify Maintena, shifts from baseline in fasting cholesterol from normal to high were reported in 2.1% (total cholesterol) and 2.2% (LDL cholesterol) and shifts from baseline from normal to low were reported in 8.5% (HDL cholesterol). Of these patients with normal baseline triglycerides, 3.6% experienced shifts to high, and 0.0% experienced shifts to very high. Combined, 1.0% of these patients with normal or borderline fasting triglycerides experienced shifts to very high fasting triglycerides during this trial.

Weight Gain

Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

In one short-term, placebo-controlled trial in adult patients with schizophrenia with Abilify Maintena, the mean change in body weight at Week 12 was +3.5 kg (N=99) in the Abilify Maintena-treated patients and +0.8 kg (N=66) in the placebo-treated patients.

Table 6 shows the percentage of adult patients with schizophrenia with weight gain ≥7% of body weight in a short-term, placebo-controlled trial with Abilify Maintena.

Table 6: Percentage of Patients From a 12-Week Placebo-Controlled Trial in Adult Patients with Schizophrenia with Weight Gain ≥7% of Body Weight

Treatment Arm Na Patients n (%)
a N = the total number of subjects who had a measurement at baseline and at least one post-baseline result.

Weight gain ≥7% of body weight

Abilify Maintena

144

31 (21.5)

Placebo

141

12 (8.5)

During a 52-week, open-label bipolar I disorder study in those patients who initiated Abilify Maintena, 1.8% discontinued Abilify Maintena treatment due to weight increase. Abilify Maintena was associated with mean increase from baseline in weight of 1.0 kg at week 52. In this trial, 21.4% of these patients demonstrated ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight.

5.6 Pathological Gambling and Other Compulsive Behaviors

Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with aripiprazole. It should be noted that impulse-control symptoms can be associated with the underlying disorder. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.

Orthostatic Hypotension

Abilify Maintena may cause orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. In the short-term, placebo-controlled trial in adults with schizophrenia, the adverse event of presyncope was reported in 1/167 (0.6%) of patients treated with Abilify Maintena, while syncope and orthostatic hypotension were each reported in 1/172 (0.6%) of patients treated with placebo. During the stabilization phase of the randomized-withdrawal (maintenance) study in adult patients with schizophrenia, orthostasis-related adverse events were reported in 4/576 (0.7%) of patients treated with Abilify Maintena, including abnormal orthostatic blood pressure (1/576, 0.2%), postural dizziness (1/576, 0.2%), presyncope (1/576, 0.2%) and orthostatic hypotension (1/576, 0.2%).

In the short-term placebo-controlled trial in adults with schizophrenia, there were no patients in either treatment group with a significant orthostatic change in blood pressure (defined as a decrease in systolic blood pressure ≥20 mmHg accompanied by an increase in heart rate ≥25 bpm when comparing standing to supine values). During the stabilization phase of the randomized-withdrawal (maintenance) study in adult patients with schizophrenia, the incidence of significant orthostatic change in blood pressure was 0.2% (1/575).

5.8 Falls

Antipsychotics, including Abilify Maintena, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.

Leukopenia, Neutropenia, and Agranulocytosis

In clinical trials and post-marketing experience, leukopenia and neutropenia have been reported temporally related to antipsychotic agents, including Abilify Maintena. Agranulocytosis has also been reported [see ADVERSE REACTIONS (6.1)].

Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC)/absolute neutrophil count (ANC) and a history of drug-induced leukopenia/neutropenia. In patients with a history of a clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia, perform a complete blood count (CBC) frequently during the first few months of therapy. In such patients, consider discontinuation of Abilify Maintena at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly if such symptoms or signs occur. Discontinue Abilify Maintena in patients with severe neutropenia (absolute neutrophil count <1000/mm3) and follow their WBC counts until recovery.

Seizures

As with other antipsychotic drugs, use Abilify Maintena cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.

Potential for Cognitive and Motor Impairment

Abilify Maintena, like other antipsychotics, may impair judgment, thinking, or motor skills. Instruct patients to avoid operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with Abilify Maintena does not affect them adversely.

Body Temperature Regulation

Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing Abilify Maintena for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, (e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration).

Dysphagia

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including Abilify Maintena. Abilify Maintena and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see WARNINGS AND PRECAUTIONS (5.1)].

Overdosage

Human Experience

The largest known case of acute ingestion with a known outcome involved 1260 mg of oral aripiprazole (42 times the maximum recommended daily dose) in a patient who fully recovered.

Common adverse reactions (reported in at least 5% of all overdose cases) reported with oral aripiprazole overdosage (alone or in combination with other substances) include vomiting, somnolence, and tremor. Other clinically important signs and symptoms observed in one or more patients with aripiprazole overdoses (alone or with other substances) include acidosis, aggression, aspartate aminotransferase increased, atrial fibrillation, bradycardia, coma, confusional state, convulsion, blood creatine phosphokinase increased, depressed level of consciousness, hypertension, hypokalemia, hypotension, lethargy, loss of consciousness, QRS complex prolonged, QT prolonged, pneumonia aspiration, respiratory arrest, status epilepticus, and tachycardia.

Management of Overdosage

In case of overdosage, call the Poison Control Center immediately at 1-800-222-1222.

Medication guide

Abilify Maintena® (a-BIL-i-fy main-TEN-a)

(aripiprazole)
for extended-release injectable suspension, for intramuscular use

What is the most important information I should know about Abilify Maintena?

Each injection of Abilify Maintena must be administered by a healthcare professional only.

Abilify Maintena may cause serious side effects, including:

• 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).

What is Abilify Maintena?

Abilify Maintena is a prescription medicine given by injection by a healthcare professional for:

• treatment of schizophrenia in adults • maintenance treatment of bipolar I disorder in adults

It is not known if Abilify Maintena is safe and effective in children under 18 years of age.

Do not receive Abilify Maintena if you are allergic to aripiprazole or any of the ingredients in Abilify Maintena. See the end of this Medication Guide for a complete list of ingredients in Abilify Maintena.

Before receiving Abilify Maintena, tell your healthcare provider about all your medical conditions, including 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 problems that may affect you receiving an injection in your arm or buttocks • are pregnant or plan to become pregnant. It is not known if Abilify Maintena will harm your unborn baby. • If you become pregnant while receiving Abilify Maintena, 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 go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ • are breastfeeding or plan to breastfeed. Abilify Maintena can pass into your breast 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 healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.

Abilify Maintena and other medicines may affect each other causing possible serious side effects. Abilify Maintena may affect the way other medicines work, and other medicines may affect how Abilify Maintena works.

Your healthcare provider can tell you if it is safe to receive Abilify Maintena with your other medicines. Do not start or stop any medicines during treatment with Abilify Maintena without talking to your healthcare provider first.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I receive Abilify Maintena?

• Follow your Abilify Maintena treatment schedule exactly as your healthcare provider tells you to. • Abilify Maintena is an injection given in your arm or buttock by your healthcare provider 1 time every month. You may feel a little pain in your arm or buttock during your injection. • After your first injection of Abilify Maintena you should continue your current antipsychotic medicine for 2 weeks. • You should not miss a dose of Abilify Maintena. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.

What should I avoid while receiving Abilify Maintena?

• Do not drive, operate machinery, or do other dangerous activities until you know how Abilify Maintena affects you. Abilify Maintena may make you feel drowsy. • Do not drink alcohol while you receive Abilify Maintena. • Do not become too hot or dehydrated while you receive Abilify Maintena. • Do not exercise too much. • In hot weather, stay inside in a cool place if possible. • Stay out of the sun. • Do not wear too much clothing or heavy clothing. • Drink plenty of water.

What are the possible side effects of Abilify Maintena?

Abilify Maintena may cause serious side effects, including:

• See "What is the most important information I should know about Abilify Maintena?" • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death. • Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest emergency room right away if you have some or all of the following symptoms of NMS: • high fever • confusion • change in pulse, heart rate, and blood pressure • stiff muscles • sweating • Uncontrolled body movements (tardive dyskinesia). Abilify Maintena may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving Abilify Maintena. Tardive dyskinesia may also start after you stop receiving Abilify Maintena. • Problems with your metabolism such as: • high blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who receive Abilify Maintena. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start receiving Abilify Maintena and during your treatment.

Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving 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 • Increased fat levels (cholesterol and triglycerides) in your blood. • Weight gain. You and your healthcare provider should check your weight regularly. • Unusual urges. Some people receiving Abilify Maintena 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. • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise 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. See "What should I avoid while receiving Abilify Maintena?" • Difficulty swallowing

The most common side effects of Abilify Maintena include: weight gain, inner sense of restlessness such as feeling like you need to move (akathisia), injection site pain, or sleepiness (sedation).

These are not all the possible side effects of Abilify Maintena. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Abilify Maintena.

If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Abilify Maintena that is written for healthcare professionals.

What are the ingredients in Abilify Maintena?

Active ingredient: aripiprazole monohydrate

Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide

Abilify Maintena is a trademark of Otsuka Pharmaceutical Co., Ltd.
© 2017, Otsuka Pharmaceutical Co., Ltd., Tokyo, 101-8535 Japan

For more information, go to www.ABILIFYMAINTENA.com or call 1-800-441-6763.

  This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 07/2017

PRINCIPAL DISPLAY PANEL - 300 mg Vial Label

NDC 59148-018-70

Rx only

300 mg per vial

Abilify Maintena™ (aripiprazole)
for extended release injectable suspension
Single use only. Sterile. Discard any unused portion.
For deltoid or gluteal intramuscular injection only.
Usual Dosage: See package insert.

Manufactured by: Otsuka Pharmaceutical Co., Ltd.
Distributed and Marketed by: Otsuka America Pharmaceutical, Inc.
Marketed by: Lundbeck

Abilify Maintena Overview

Abilify Maintena is a prescription medication used to treat symptoms of schizophrenia. It is also approved for acute schizophrenia relapse in adults.

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 Interactions

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.

Abilify Maintena and Pregnancy

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.

For the Consumer

Applies to aripiprazole: oral solution, oral tablet, oral tablet disintegrating

Other dosage forms:

  • intramuscular powder for suspension extended release, intramuscular solution

Along with its needed effects, aripiprazole (the active ingredient contained in Abilify Maintena) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aripiprazole:

More common
  • Difficulty with speaking
  • drooling
  • loss of balance control
  • muscle trembling, jerking, or stiffness
  • restlessness
  • shuffling walk
  • stiffness of the limbs
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back
Less common
  • Blurred vision
  • dizziness
  • headache
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat
  • sticking out the tongue
  • trouble with breathing or swallowing
  • unusual facial expressions
Rare
  • Convulsions
  • fast heartbeat
  • high fever
  • high or low blood pressure
  • increased sweating
  • lip smacking or puckering
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • severe muscle stiffness
  • sudden loss of consciousness
  • tiredness
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusually pale skin
Incidence not known
  • Hives or welts, itching, or skin rash
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • redness of the skin
  • tightness in the chest
  • unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking aripiprazole:

Symptoms of overdose
  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • diarrhea
  • fast, pounding, or irregular heartbeat or pulse
  • increased sensitivity of the eyes to light
  • lack or loss of strength
  • nausea
  • sleepiness or unusual drowsiness
  • vomiting

Some side effects of aripiprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • anxiety
  • belching
  • blurred vision
  • difficulty having a bowel movement (stool)
  • dry mouth
  • fear
  • fever
  • headache
  • heartburn
  • hyperventilation
  • inability to sit still
  • indigestion
  • irritability
  • lightheadedness
  • need to keep moving
  • nervousness
  • rash
  • runny nose
  • shaking
  • sore throat
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • weight gain
Less common
  • Accidental injury
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • congestion
  • coughing
  • difficulty with moving
  • dryness or soreness of the throat
  • hoarseness
  • increased appetite
  • increased salivation
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • rapid weight gain
  • sneezing
  • stuffy nose
  • swollen joints
  • tender, swollen glands in the neck
  • tingling of the hands or feet
  • tremor
  • unusual weight gain or loss
  • voice changes

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