Brand names: Abilify, Aristada
Drug class: Atypical Antipsychotics
- Dopamine Receptor Partial Agonists
ATC class: N05AX12
VA class: CN709
Chemical name: 3,4-Dihydro-7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-2(1H)-quinolinone
Molecular formula: C₂₃H₂₇Cl₂N₃O₂ C₃₆H₅₁Cl₂N₃O₄
CAS number: 129722-12-9

Medically reviewed by Drugs.com on Apr 19, 2024. Written by ASHP.

Introduction

Quinolinone derivative; atypical or second-generation antipsychotic agent.

Uses for Aripiprazole

Schizophrenia

Used orally (as aripiprazole) and IM (as extended-release aripiprazole or aripiprazole lauroxil injection) for treatment of schizophrenia.

American Psychiatric Association (APA) considers most atypical antipsychotic agents first-line drugs for the management of the acute phase of schizophrenia (including first psychotic episodes).

Patients who do not respond to or tolerate one drug may be successfully treated with an agent from a different class or with a different adverse effect profile.

Immediate-release aripiprazole injection (no longer commercially available in the US) has been used IM for acute management of agitation in patients with schizophrenia.

Bipolar Disorder

Used orally alone or in conjunction with lithium or valproate for acute treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features. Also used orally as monotherapy or as adjunctive therapy with lithium or valproate for maintenance treatment of bipolar I disorder.

Used IM (as extended-release aripiprazole injection [Abilify Maintena]) as monotherapy for maintenance treatment of bipolar I disorder.

Immediate-release aripiprazole injection (no longer commercially available in the US) has been used IM for acute management of agitation in patients with bipolar I disorder.

Adjunctive Therapy of Major Depressive Disorder

Used orally as adjunctive therapy to antidepressants for treatment of major depressive disorder.

Irritability Associated with Autistic Disorder

Used orally for acute treatment of irritability associated with autistic disorder.

Tourette's Syndrome

Used orally for treatment of Tourette's syndrome (Gilles de la Tourette’s syndrome).

Aripiprazole Dosage and Administration

General

• Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

• When switching from other antipsychotic agents to aripiprazole, abrupt discontinuance of previous agent may be acceptable for some patients with schizophrenia, but gradual discontinuance may be most appropriate for others. In all cases, minimize period of overlapping antipsychotic administration.

• Aripiprazole tablets with sensor (Abilify MyCite) are part of a digital ingestion tracking system intended to provide objective data on drug ingestion. (See Aripiprazole Tablets with Sensor under Actions.) The ability of aripiprazole tablets with sensor to improve patient compliance or usefulness in modifying aripiprazole dosage has not been established. Use of aripiprazole tablets with sensor to track drug ingestion in real time or during an emergency is not recommended because detection may be delayed or may not occur. (See Precautions Related to Aripiprazole Tablets with Sensor under Cautions.)

Administration

Administer aripiprazole orally or by IM injection. Administer aripiprazole lauroxil only by IM injection.

Establish tolerability with oral aripiprazole prior to initiating IM therapy with extended-release aripiprazole or aripiprazole lauroxil.

Oral Administration

Administer orally as conventional tablets, tablets with sensor, orally disintegrating tablets, or oral solution once daily without regard to meals. (See Food under Pharmacokinetics.)

Orally Disintegrating Tablets

Just prior to administration, peel open blister package; with dry hands, remove orally disintegrating tablet. Do not push tablet through foil.

Place tablet on tongue to dissolve; manufacturer recommends taking without liquid, but may take with liquid, if necessary.

Do not divide orally disintegrating tablet.

Tablets with Sensor (Abilify MyCite)

Aripiprazole is available as part of a digital ingestion tracking system comprised of the following components: aripiprazole tablets embedded with an ingestible event marker sensor (IEM; Abilify MyCite); a wearable sensor (MyCite patch), which detects the signal from the ingested sensor and transmits data to a compatible mobile device (i.e., a smart phone); a software application (app) for compatible mobile devices (e.g., smart phones; MyCite App), which displays information for the patient; and a web-based portal for healthcare professionals and caregivers.

Prior to initial patient use, facilitate use of the Abilify MyCite system. Ensure that patients are capable and willing to use a mobile device and the software application. Before using any component of the system, instruct patients to download the application and follow all the instructions for use and ensure that the software is compatible with their specific mobile device.

Administer tablets with sensor once daily without regard to meals. Swallow tablets whole; do not divide, crush, or chew.

Prior to use of the software application, the patient's mobile device should be powered on and Bluetooth enabled. Patients should apply the accompanying wearable sensor when prompted by the mobile software application; the application will instruct patients to apply and remove the sensor correctly. Patients should confirm that their mobile device is paired with the wearable sensor prior to use; the mobile software application will display a status icon on the mobile device to indicate that the patch is properly adhered and functioning. For further information, refer to the information provided in the product packaging as well as the instructions for use within the mobile software application.

Most ingestions of aripiprazole tablets with sensor will be detected within 30 minutes following ingestion; however, it may take up to 2 hours for the smart phone application and web portal to detect the ingestion. In some cases, ingestion of the tablet sensor may not be detected. If the tablet with sensor is not detected following ingestion, do not repeat the dose.

Apply the wearable sensor topically to the left side of the body just above the lower edge of the rib cage. Avoid application to areas where the skin is scraped, cracked, inflamed, or irritated or areas overlapping the area of the most recently removed sensor.

Change the wearable sensor weekly or sooner as needed; the mobile software application will remind patients when to change the sensor. Instruct patients to keep the wearable sensor in place while showering, swimming, or exercising. Remove the wearable sensor before undergoing magnetic resonance imaging (MRI) and replace with a new sensor as soon as possible.

If skin irritation occurs, remove the wearable sensor. (See Skin Irritation associated with Abilify MyCite Wearable Sensor under Cautions.)

IM Administration of Extended-release Aripiprazole (Abilify Maintena)

Extended-release IM aripiprazole is available in 300- and 400-mg vials and prefilled syringes; do not confuse this formulation with extended-release aripiprazole lauroxil (Aristada and Aristada Initio, which are available in 441-, 662-, 675-, 882-, and 1064-mg prefilled syringes) or the immediate-release IM aripiprazole formulation (Abilify; 9.75 mg/vial), which is no longer commercially available in the US.

Must be administered by a healthcare professional.

Administer extended-release aripiprazole injection only by deep IM injection slowly into the deltoid or gluteal muscle. Do not massage injection site following IM administration. Rotate injection sites.

Administer monthly; allow at least 26 days to elapse between doses.

Reconstitution

Abilify Maintena is commercially available in 2 types of kits that contain aripiprazole lyophilized powder in either single-use vials or prefilled dual-chamber syringes with all the components required for reconstitution and administration (e.g., sterile water for injection diluent, needles, syringes); consult manufacturer's instructions for use for specific information on preparation, reconstitution, and administration.

Because entire contents of prefilled dual-chamber syringes should be administered after reconstitution, use single-use vials for dosages <300 mg.

Following reconstitution, shake prefilled syringe or vials vigorously for 20 or 30 seconds, respectively, to ensure a uniform and homogeneous suspension, which appears opaque and milky-white. If using vials, withdraw the appropriate dose of aripiprazole using the syringe supplied by the manufacturer. If a vial of reconstituted suspension is not administered immediately, shake the vial vigorously for at least 60 seconds to resuspend the drug; do not store in syringe after reconstitution. If using prefilled syringes, inject entire contents immediately following reconstitution (i.e., within 30 minutes).

IM Administration of Extended-release Aripiprazole Lauroxil (Aristada, Aristada Initio)

Extended-release aripiprazole lauroxil (Aristada) is available in 441-, 662-, 882-, and 1064-mg prefilled syringes for the treatment of schizophrenia; do not confuse this formulation with extended-release aripiprazole (Abilify Maintena; available in 300- and 400-mg vials and prefilled syringes) or the immediate-release aripiprazole formulation (no longer commercially available in the US).

Extended-release aripiprazole lauroxil injection also is available in 675-mg prefilled syringes (Aristada Initio). Use only as a single IM dose to initiate treatment or as a single dose to re-initiate treatment following a missed dose of extended-release aripiprazole lauroxil (Aristada). Aristada Initio is for single-dose administration only; do not use for repeated dosing. Aristada Initio is not interchangeable with Aristada because of their different pharmacokinetic profiles.

Must be administered by a healthcare professional.

Available as kits containing extended-release aripiprazole lauroxil injectable suspension in prefilled syringes and safety needles for IM injection. Prior to use, tap the prefilled syringe ≥10 times to dislodge any material that may have settled, then shake vigorously for ≥30 seconds to ensure a uniform suspension. If not administered within 15 minutes, shake the syringe again for 30 seconds.

Administer only by IM injection rapidly and continuously into the deltoid (for 441- and 675-mg doses only) or gluteal muscle (for 441-, 662-, 675-, 882-, and 1064-mg doses). Select needle based on injection site; use longer needles in patients with a larger amount of subcutaneous tissue overlaying the injection site muscle. Avoid concurrent administration of the 2 different aripiprazole lauroxil injection formulations (Aristada Initio and Aristada) in the same muscle.

Administer 441- and 662-mg doses of extended-release aripiprazole lauroxil (Aristada) monthly; may administer the 882-mg dose monthly or every 6 weeks. Administer 1064-mg doses every 2 months. Allow at least 14 days to elapse between doses.

Dosage

Aripiprazole oral solution may be given at same dose on mg-per-mg basis as the tablet strengths of the drug up to a dose of 25 mg. However, if oral solution is used in patients receiving 30-mg tablets, use a dose of 25 mg of the oral solution.

Dosing of aripiprazole orally disintegrating tablets is the same as for conventional tablets of the drug.

Dosage of aripiprazole lauroxil expressed in terms of aripiprazole lauroxil.

Extended-release aripiprazole lauroxil (Aristada) doses of 441, 662, 882, and 1064 mg correspond to aripiprazole doses of 300, 450, 600, and 724 mg, respectively.

If used with CYP3A4 inhibitors, CYP2D6 inhibitors, and/or CYP3A4 inducers, dosage adjustment may be required. (See Interactions.)

Pediatric Patients

Schizophrenia

Oral

Adolescents ≥13 years of age: Recommended target dosage for treatment is 10 mg once daily. Therapy has been initiated at 2 mg once daily, with subsequent titration to 5 mg once daily after 2 days and to 10 mg once daily after 2 additional days.

Subsequent dosage increases should be made in 5-mg, once-daily increments.

Dosages of 10 and 30 mg once daily evaluated in clinical trials; the 30-mg daily dosage was not more effective than the 10-mg daily dosage in adolescents.

Although efficacy as maintenance treatment not systematically evaluated in adolescents with schizophrenia, the manufacturer states that such efficacy can be extrapolated from adult data in addition to comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. Periodically reassess need for continued therapy. (See Pediatric Use under Cautions.)

Bipolar Disorder

Manic or Mixed Episodes: Monotherapy or Combination Therapy

Oral

Children and adolescents ≥10 years of age: Target dosage for acute treatment is 10 mg once daily. Recommended initial dosage when given as monotherapy is 2 mg once daily, with subsequent titration to 5 mg once daily after 2 days and to the target dosage of 10 mg once daily after 2 additional days.

Recommended dosage when aripiprazole is given as adjunctive therapy with lithium or valproate is the same as that for monotherapy.

Daily dosage may be increased, if necessary, in 5-mg increments. In pediatric clinical studies, dosages of 10 and 30 mg daily were effective.

Irritability Associated with Autistic Disorder

Oral

Children and adolescents 6–17 years of age: Initially, 2 mg once daily, then increase dosage to 5 mg daily, with subsequent increases to 10 or 15 mg daily, if necessary. Increase dosage gradually, at intervals of ≥1 week. Efficacy established within a dosage range of 5–15 mg daily in clinical studies.

Periodically reassess need for continued therapy.

Tourette's Syndrome

Oral

Children and adolescents 6–18 years of age weighing <50 kg: Initially, 2 mg once daily for 2 days, then increase dosage to 5 mg once daily. If optimal control of tics not achieved, may increase dosage to 10 mg once daily. Adjust dosage gradually at intervals of ≥1 week.

Children and adolescents 6–18 years of age weighing ≥50 kg: Initially, 2 mg once daily for 2 days, then increase to 5 mg once daily for 5 days, with a recommended target dosage of 10 mg once daily on day 8. If optimal control of tics not achieved, may increase dosage up to 20 mg once daily. Adjust dosage gradually in increments of 5 mg daily at intervals of ≥1 week.

Periodically reassess need for continued maintenance therapy.

Adults

Schizophrenia

Oral

Initial and target dosage for treatment is 10 or 15 mg once daily.

Dosages ranging from 10–30 mg once daily were effective in clinical trials; dosages exceeding 10–15 mg daily did not result in greater efficacy.

Adjust dosage at intervals of ≥2 weeks, the time needed to achieve steady-state concentrations.

Efficacy as maintenance therapy for ≤26 weeks has been demonstrated; other clinical experience indicates may be effective for up to 52 weeks. Optimum duration of therapy is not known, but maintenance therapy with antipsychotics is well established.

Periodically reassess need for continued therapy.

In patients with remitted first or multiple episodes, APA recommends either indefinite maintenance therapy or gradual discontinuance of the antipsychotic with close follow-up and a plan to reinstitute treatment upon symptom recurrence. Consider antipsychotic therapy discontinuance only after ≥1 year of symptom remission or optimal response while taking antipsychotic. Indefinite maintenance treatment is recommended if multiple previous psychotic episodes or 2 episodes within 5 years.

IM, Extended-release Aripiprazole (Abilify Maintena)

For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating extended-release IM aripiprazole therapy; may take up to 2 weeks to fully assess tolerability due to the half-life of oral aripiprazole.

Usual initial and maintenance dosage: 400 mg IM every month (no sooner than 26 days following the previous injection). May reduce dosage to 300 mg every month in patients experiencing adverse effects.

Administer oral aripiprazole 10–20 mg daily (or another oral antipsychotic agent in patients already stable on another oral antipsychotic and known to tolerate aripiprazole) with the first extended-release IM aripiprazole injection and continue oral therapy for 14 days thereafter to ensure adequate therapeutic plasma concentrations are maintained.

If a dose of extended-release aripiprazole injection is missed, administer the next dose as soon as possible. Supplementation with oral aripiprazole may be required depending on the time elapsed (see Table 1).

IM, Extended-release Aripiprazole Lauroxil (Aristada)

For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating extended-release IM aripiprazole lauroxil therapy; may take up to 2 weeks to fully assess tolerability due to the half-life of oral aripiprazole.

Depending on individual patient's needs, may initiate therapy at an IM dosage of 441, 662, or 882 mg every month; 882 mg every 6 weeks; or 1064 mg every 2 months.

Administer oral aripiprazole daily with the first IM aripiprazole lauroxil injection and continue oral aripiprazole therapy for 21 days thereafter.

For patients established on oral aripiprazole 10 mg daily, recommended IM dosage of aripiprazole lauroxil is 441 mg every month.

For patients established on oral aripiprazole 15 mg daily, recommended IM dosage of aripiprazole lauroxil is 662 mg every month, 882 mg every 6 weeks, or 1064 mg every 2 months.

For patients established on oral aripiprazole ≥20 mg daily, recommended IM dosage of aripiprazole lauroxil is 882 mg every month.

Adjust dosage as needed. Consider pharmacokinetics and prolonged-release characteristics of extended-release aripiprazole lauroxil injection when adjusting dose and dosing interval.

If a dose is missed, administer the next dose as soon as possible. Supplementation with oral aripiprazole and/or a 675-mg IM dose of extended-release aripiprazole lauroxil (Aristada Initio) may be required depending on the dosage and the time elapsed (see Tables 2 and 3).

Dosage of oral aripiprazole supplementation should be same as when patient began extended-release aripiprazole lauroxil therapy.

IM, Extended-release Aripiprazole Lauroxil (Aristada Initio)

For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating IM therapy with extended-release aripiprazole lauroxil (Aristada Initio); may take up to 2 weeks to fully assess tolerability.

Use the 675-mg strength of extended-release aripiprazole lauroxil injection (Aristada Initio) only as a single dose to initiate aripiprazole lauroxil therapy or as a single dose to reinitiate therapy following a missed dose of extended-release aripiprazole lauroxil injection (Aristada). Do not use the 675-mg strength for repeated dosing.

For initiation of aripiprazole lauroxil therapy after establishing tolerability with oral aripiprazole, may administer the first IM injection of aripiprazole lauroxil (Aristada; 441, 662, 882, or 1064 mg) in conjunction with both one 675-mg IM injection of aripiprazole lauroxil (Aristada Initio) (this dosage is equivalent to 459 mg of aripiprazole) and one 30-mg dose of oral aripiprazole.

May administer the first dosage of aripiprazole lauroxil (Aristada) on the same day as Aristada Initio or up to 10 days thereafter. Avoid injecting both formulations concurrently into the same deltoid or gluteal muscle.

For re-initiation of aripiprazole lauroxil (Aristada) therapy following a missed dose, administer the next injection of aripiprazole lauroxil (Aristada) as soon as possible. Depending on the time elapsed since the last Aristada injection, the next Aristada injection may be supplemented as recommended in Table 3.

Bipolar Disorder

Manic or Mixed Episodes: Monotherapy or Combination Therapy

Oral

Monotherapy: Initially, 15 mg once daily.

Adjunctive therapy to lithium or valproate: Initial dosage of 10–15 mg once daily.

Recommended target dosage is 15 mg once daily whether the drug is given as monotherapy or as adjunctive therapy with lithium or valproate. Based on patient response, may increase dosage to 30 mg once daily.

Safety of dosages >30 mg daily not established.

Maintenance Therapy

IM, Extended-release Aripiprazole (Abilify Maintena)

For patients naive to aripiprazole, establish tolerability with oral aripiprazole prior to initiating extended-release IM aripiprazole therapy; may take up to 2 weeks to fully assess tolerability due to the half-life of oral aripiprazole.

Usual initial and maintenance dosage: 400 mg IM every month (no sooner than 26 days following the previous injection). May reduce dosage to 300 mg every month in patients experiencing adverse effects.

Administer oral aripiprazole 10–20 mg daily (or another oral antipsychotic agent in patients already stable on another oral antipsychotic agent and known to tolerate aripiprazole) with the first extended-release IM aripiprazole injection and continue oral therapy for 14 days thereafter to ensure adequate therapeutic plasma concentrations are maintained.

If a dose of extended-release aripiprazole injection is missed, administer the next dose as soon as possible. Supplementation with oral aripiprazole may be required depending on the time elapsed (see Table 1).

Major Depressive Disorder

Oral

Initially, 2–5 mg once daily as adjunctive acute therapy.

Gradually adjust dosage in increments of ≤5 mg daily at ≥1-week intervals; the recommended dosage range is 2–15 mg once daily. Dosages of 2–15 mg daily (mean dosage: approximately 11 mg daily) were effective in clinical trials.

Periodically reassess need for continued therapy.

Manufacturer does not recommend aripiprazole dosage adjustment when administered as adjunctive therapy for major depressive disorder concurrently with CYP2D6 inhibitors. (See Interactions.)

Prescribing Limits

Pediatric Patients

Schizophrenia

Oral

Safety of dosages >30 mg daily not established.

Bipolar Disorder

Manic or Mixed Episodes

Oral

Safety of dosages >30 mg daily not established.

Irritability Associated with Autistic Disorder

Oral

Safety and efficacy of dosages >15 mg daily not established.

Tourette's Syndrome

Oral

Weight <50 kg: Maximum 10 mg daily.

Weight ≥50 kg: Maximum 20 mg daily.

Adults

Schizophrenia

Oral

Safety and efficacy of dosages >30 mg daily not established.

IM, Extended-release Aripiprazole (Abilify Maintena)

Safety and efficacy of dosages >400 mg every month not established.

Bipolar Disorder

Manic or Mixed Episodes

Oral

Safety and efficacy of dosages >30 mg daily not established.

Adjunctive Therapy of Major Depressive Disorder

Oral

Safety and efficacy of dosages >15 mg daily not established.

Special Populations

Hepatic Impairment

Dosage adjustment not required.

Renal Impairment

Dosage adjustment not required.

Geriatric Patients

Dosage adjustment not required.

Gender, Race, or Smoking Status

Dosage adjustment not required.

Pharmacogenomics and Poor CYP2D6 Metabolizer Phenotype

For dosage adjustments related to CYP-mediated interactions in populations other than patients with poor CYP2D6 metabolizer phenotype, see Interactions.

Oral Aripiprazole

Reduce oral dosage to 50% of the usual dosage; dosage adjustment not required when used as adjunctive treatment of major depressive disorder.

If patients who are poor CYP2D6 metabolizers are concomitantly receiving a potent CYP3A4 inhibitor, reduce oral aripiprazole dosage to 25% of the usual dosage. (See Interactions.)

Extended-release IM Aripiprazole Injection (Abilify Maintena)

Reduce dosage to 300 mg every month.

If patients who are poor CYP2D6 metabolizers are concomitantly receiving a potent CYP3A4 inhibitor, reduce dosage of extended-release IM aripiprazole injection to 200 mg every month. Dosage adjustment not required for concomitant use <2 weeks. (See Interactions.)

Extended-release IM Aripiprazole Lauroxil Injection (Aristada)

Reduce dosage based on patient's established oral dosage.

If patients who are poor CYP2D6 metabolizers are concomitantly receiving a potent CYP3A4 inhibitor, reduce dosage of extended-release IM aripiprazole lauroxil injection from 662, 882, or 1064 mg to 441 mg every month. Dosage adjustment not necessary in patients already receiving 441 mg every month, if tolerated. Dosage adjustment not required for concomitant use <2 weeks. (See Interactions.)

No further dosage adjustment required in patients who are poor CYP2D6 metabolizers receiving a concomitant potent CYP2D6 inhibitor. (See Interactions.)

Extended-release IM Aripiprazole Lauroxil Injection (Aristada Initio)

Avoid use in patients who are poor CYP2D6 metabolizers. Only a single strength (675 mg) is available; therefore, dosage adjustments are not possible.

Cautions for Aripiprazole

Contraindications

• Known hypersensitivity to aripiprazole; hypersensitivity reactions have ranged from pruritus/urticaria to anaphylaxis. (See Sensitivity Reactions under Cautions.)

Warnings/Precautions

Warnings

Increased Mortality in Geriatric Patients with Dementia-related Psychosis

Increased risk of death with use of either conventional (first-generation) or atypical (second-generation) antipsychotics in geriatric patients with dementia-related psychosis.

Antipsychotic agents, including aripiprazole, are not approved for the treatment of dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis in Boxed Warning, see Cerebrovascular Events in Geriatric Patients with Dementia-related Psychosis under Cautions, and see Dysphagia under Cautions.)

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs. (See Boxed Warning and also see Pediatric Use under Cautions.) However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

Appropriately monitor and closely observe patients receiving aripiprazole for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality. Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.

Sensitivity Reactions

Allergic and sensitivity reactions (e.g., anaphylactic reaction, angioedema, laryngospasm, pruritus/urticaria, photosensitivity, rash, oropharyngeal spasm) reported in aripiprazole-treated patients. (See Contraindications under Cautions.)

Other Warnings and Precautions

Cerebrovascular Events in Geriatric Patients with Dementia-related Psychosis

Increased incidence of adverse cerebrovascular events (cerebrovascular accidents and TIAs), including fatalities, observed in geriatric patients with dementia-related psychosis treated with aripiprazole in several placebo-controlled studies. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis in Boxed Warning.)

Potential for Dosing and Medication Errors

Substitution and dispensing errors between the 2 different extended-release IM formulations of aripiprazole lauroxil, Aristada Initio and Aristada, may occur.

Aristada Initio is for single-dose administration only. Do not substitute Aristada Initio for Aristada because of their different pharmacokinetic profiles.

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome characterized by hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability, reported with antipsychotic agents, including some rare cases in patients treated with aripiprazole.

Immediately discontinue therapy and initiate supportive and symptomatic treatment if NMS occurs. Careful monitoring recommended if therapy is reinstituted following recovery; the risk that NMS can recur must be considered.

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary dyskinetic movements, reported with use of antipsychotic agents, including aripiprazole.

Reserve long-term antipsychotic treatment for patients with chronic illness known to respond to antipsychotic agents, and for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients requiring chronic treatment, use smallest dosage and shortest duration of treatment producing a satisfactory clinical response; periodically reassess need for continued therapy.

APA recommends assessing patients receiving atypical antipsychotic agents for abnormal involuntary movements every 12 months; for patients at increased risk for tardive dyskinesia, assess every 6 months. Consider discontinuance of aripiprazole if signs and symptoms of tardive dyskinesia appear. However, some patients may require treatment despite the presence of the syndrome.

Metabolic Changes

Atypical antipsychotic agents are associated with metabolic changes, including hyperglycemia and diabetes mellitus, dyslipidemia, and weight gain. While all atypical antipsychotics produce some metabolic changes, each drug has its own specific risk profile. (See Hyperglycemia and Diabetes Mellitus, see Dyslipidemia, and also see Weight Gain under Cautions.)

Hyperglycemia and Diabetes Mellitus

Hyperglycemia, sometimes severe and associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents. In short- and longer-term clinical studies in adult and pediatric patients, clinically important differences between oral aripiprazole and placebo in mean change from baseline to end point in serum glucose concentrations not observed.

Periodically monitor patients with an established diagnosis of diabetes mellitus for worsening of glucose control and perform fasting glucose testing at baseline and periodically in patients with risk factors for diabetes (e.g., obesity, family history of diabetes). If manifestations of hyperglycemia occur in any aripiprazole-treated patient, perform fasting blood glucose testing. (See Advice to Patients.)

Some patients who developed hyperglycemia while receiving an atypical antipsychotic have required continuance of antidiabetic treatment despite discontinuance of the atypical antipsychotic; in other patients, hyperglycemia resolved with discontinuance of the antipsychotic.

Dyslipidemia

Undesirable changes in lipid parameters observed in patients treated with some atypical antipsychotics. However, aripiprazole generally does not appear to adversely affect the lipid profile.

Weight Gain

Weight gain observed with atypical antipsychotic therapy. Monitoring of weight recommended during aripiprazole therapy. (See Hyperglycemia and Diabetes Mellitus under Cautions.)

Pathological Gambling and Other Compulsive Behaviors

Serious impulse-control and compulsive behaviors, particularly pathological gambling, reported in adult and pediatric patients treated with aripiprazole.

In May 2016, FDA reported that 184 cases of impulse-control problems associated with aripiprazole therapy had been identified since November 2002; 89% of the cases involved pathological gambling. Other impulse-control and compulsive behaviors (e.g., compulsive or binge eating, compulsive spending or shopping, compulsive sexual behaviors) reported less frequently. Most of the patients had no history of compulsive behaviors and experienced the uncontrollable urges only after beginning aripiprazole treatment.

Impulse-control symptoms may also be associated with the underlying disorder. The results of a large pharmacoepidemiologic study suggest that patients with bipolar disorder who are receiving aripiprazole have a higher risk of gambling compared with patients with bipolar disorder who are not receiving aripiprazole.

In some, but not all, cases, uncontrollable urges stopped within days to weeks following aripiprazole dosage reduction or discontinuance; recurrence of compulsive behaviors following rechallenge reported.

Compulsive behaviors may result in harm to the patient or others if not recognized. Because patients may not recognize such behaviors as abnormal, specifically ask patients whether they have developed any new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while receiving the drug.

If an aripiprazole-treated patient develops new or increased impulsive or compulsive behaviors, consider reducing the dosage or discontinuing the drug. (See Advice to Patients.)

Orthostatic Hypotension

Risk of orthostatic hypotension associated with adverse effects, including postural dizziness, syncope, and tachycardia, perhaps because of aripiprazole's α₁-adrenergic blocking activity. Risk generally appears greatest during initiation of therapy and dosage titration.

Use with caution in patients with known cardiovascular or cerebrovascular disease and/or conditions that would predispose them to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy) and in antipsychotic-naive patients. In such patients who are receiving extended-release IM aripiprazole lauroxil therapy, consider a lower initial dosage and monitoring of orthostatic vital signs.

Falls

May cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.

In patients with diseases or conditions or receiving other drugs that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic therapy and repeat such testing periodically during long-term therapy.

Leukopenia, Neutropenia, and Agranulocytosis

Leukopenia and neutropenia temporally related to antipsychotic agents, including aripiprazole, reported during clinical trial and/or postmarketing experience. Agranulocytosis also reported.

Possible risk factors for leukopenia and neutropenia include preexisting low WBC count and a history of drug-induced leukopenia or neutropenia. Monitor CBC frequently during the first few months of therapy in patients with such risk factors. Discontinue aripiprazole at the first sign of a decline in WBC count in the absence of other causative factors.

Carefully monitor patients with neutropenia for signs and symptoms of infection (e.g., fever) and treat promptly if they occur. Discontinue aripiprazole if severe neutropenia (ANC <1000/mm³) occurs; monitor WBC until recovery occurs.

Seizures

Seizures/convulsions reported in 0.1% of adult and pediatric patients (6–18 years of age) treated with oral aripiprazole.

Use with caution in patients with a history of seizures or with conditions known to lower the seizure threshold; such conditions may be more prevalent in patients ≥65 years of age.

Cognitive and Motor Impairment

Judgment, thinking, or motor skills may be impaired.

Somnolence (including sedation) reported in 11% of adults treated with oral aripiprazole compared with 6% of those receiving placebo in short-term clinical trials. Somnolence (including sedation) reported in 24% of pediatric patients (6–17 years of age) receiving aripiprazole compared with 6% of those receiving placebo. (See Advice to Patients.)

Body Temperature Regulation

Antipsychotic agents may disrupt ability to reduce core body temperature.

Use appropriate caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).

Suicide

Attendant risk with psychotic illnesses, bipolar disorder, and major depressive disorder; closely supervise high-risk patients. Prescribe in the smallest quantity consistent with good patient management to reduce the risk of overdosage.

Dysphagia

Esophageal dysmotility and aspiration associated with the use of antipsychotic agents, including aripiprazole.

Aspiration pneumonia is a common cause of morbidity and mortality in geriatric patients, particularly in those with advanced Alzheimer’s dementia. (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis in Boxed Warning.) Use with caution in patients at risk for aspiration pneumonia.

Phenylketonuria

Each 10- or 15-mg Abilify Discmelt orally disintegrating tablet contains aspartame (NutraSweet), which is metabolized in the GI tract to provide about 1.12 or 1.68 mg of phenylalanine, respectively.

Precautions Related to Aripiprazole Tablets with Sensor

Ability of tablets with sensor (Abilify MyCite) to improve patient adherence or usefulness in modifying aripiprazole dosage not established.

Tablets with sensor not recommended for tracking realtime drug ingestion or during an emergency since detection of ingestion may be delayed or not occur. (See Tablets with Sensor [Abilify MyCite] under Dosage and Administration.)

Skin Irritation associated with Abilify MyCite Wearable Sensor

Skin irritation (e.g., rash, pruritus, discoloration) may occur at the application site of the wearable sensor (MyCite patch). In clinical studies, 12.4% of patients receiving aripiprazole tablets with sensor experienced rashes at placement sites.

If skin irritation occurs, remove the wearable sensor.

Specific Populations

Pregnancy

Risk for extrapyramidal and/or withdrawal symptoms (e.g., agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, feeding disorder) in neonates exposed to antipsychotic agents during the third trimester; monitor neonates exhibiting such symptoms. Symptoms varied in severity; some neonates recovered within hours to days without specific treatment, while others have required intensive care unit support and prolonged hospitalization.

National Pregnancy Registry for Atypical Antipsychotics: 866-961-2388 and [Web].

Lactation

Distributed into milk in humans. However, data are insufficient to determine the amount present in human milk, the effects of the drug on breast-fed infants, or the effects on milk production.

Because of the potential for serious adverse reactions to aripiprazole in nursing infants, the manufacturer of aripiprazole tablets states that a decision should be made whether to discontinue nursing or the drug, taking into consideration the importance of the drug to the woman.

The manufacturers of extended-release IM formulations of aripiprazole state that the benefit of aripiprazole therapy to the woman as well as the benefits of breast-feeding to the infant should be weighed against the potential risk to the infant from exposure to the drug or from the underlying maternal condition.

Pediatric Use

Safety and efficacy of aripiprazole tablets with sensor not established in pediatric patients.

Safety and efficacy of oral aripiprazole not established in pediatric patients with major depressive disorder. Safety and efficacy of extended-release IM aripiprazole and aripiprazole lauroxil not evaluated in pediatric patients <18 years of age.

Safety and efficacy of oral aripiprazole for acute management of schizophrenia in pediatric patients 13–17 years of age established in a placebo-controlled study of 6 weeks' duration. Efficacy for maintenance treatment not established, but can be extrapolated from adult data and pharmacokinetic comparisons between adult and pediatric populations.

Safety and efficacy of oral aripiprazole monotherapy for acute management of bipolar mania in pediatric patients 10–17 years of age established in a placebo-controlled study of 4 weeks' duration.

Efficacy of oral aripiprazole as adjunctive therapy to lithium or valproate for management of manic or mixed episodes associated with bipolar disorder in pediatric patients not systematically evaluated. However, efficacy can be extrapolated from adult data and pharmacokinetic comparisons between adult and pediatric populations.

Safety and efficacy of oral aripiprazole for treatment of irritability associated with autistic disorder in pediatric patients 6–17 years of age established in 2 placebo-controlled clinical studies of 8 weeks’ duration. Efficacy as maintenance treatment not established in a longer-term, placebo-controlled relapse prevention trial in pediatric patients 6–17 years of age.

Safety and efficacy of oral aripiprazole for treatment of Tourette's syndrome in pediatric patients 6–18 years of age established in 2 short-term, placebo-controlled trials of 8 and 10 weeks' duration. Efficacy as maintenance therapy not systematically evaluated.

Mean weight gain of 1.6 kg reported in pediatric patients with schizophrenia or bipolar disorder receiving oral aripiprazole compared with a gain of 0.3 kg in those receiving placebo in 2 short-term studies; from baseline to 24 weeks, mean weight gain was 5.8 kg in aripiprazole-treated patients compared with 1.4 kg in placebo recipients. Similar weight gain observed in short-term studies in pediatric patients with Tourette's syndrome or with irritability associated with autistic disorder.

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others). However, a later meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation. No suicides occurred in these pediatric trials.

Geriatric Use

Insufficient experience with oral and extended-release IM formulations of aripiprazole in patients ≥65 years of age to determine whether they respond differently than younger adults. Manufacturer states that dosage adjustment of oral and IM aripiprazole based on age alone in geriatric patients is not necessary.

Safety and efficacy of extended-release IM aripiprazole lauroxil not evaluated in patients >65 years of age; manufacturer makes no specific dosage recommendations for geriatric patients.

Geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death; increased incidence of cerebrovascular events also observed with aripiprazole. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis. (See Boxed Warning, see Cerebrovascular Events in Geriatric Patients with Dementia-related Psychosis under Cautions, and see Dysphagia under Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo. (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Pharmacogenomics and Poor CYP2D6 Metabolizers

Because higher plasma concentrations of aripiprazole are likely, dosage adjustment recommended for patients known to be poor metabolizers of CYP2D6. Approximately 8% of Caucasians and 3–8% of Blacks/African Americans cannot metabolize CYP2D6 substrates and are classified as poor CYP2D6 metabolizers. (See Pharmacogenomics and Poor CYP2D6 Metabolizer Phenotype under Dosage and Administration.)

Common Adverse Effects

Oral aripiprazole (adults): Nausea, vomiting, constipation, sedation, fatigue, headache, dizziness, akathisia, anxiety, insomnia, restlessness, tremor, extrapyramidal disorder, blurred vision.

Oral aripiprazole (pediatric patients): Somnolence or sedation, headache, nausea, vomiting, tremor, extrapyramidal disorder, increased appetite, fatigue, insomnia, akathisia, nasopharyngitis, blurred vision, salivary hypersecretion, dizziness, increased weight.

Aripiprazole tablets with sensor and digital ingestion tracking system (Abilify MyCite): Skin irritation (e.g., rash, pruritus, discoloration) localized at application site of the wearable sensor.

IM aripiprazole, extended-release: Increased weight, akathisia, injection site pain, sedation.

IM aripiprazole lauroxil, extended-release: Akathisia, extrapyramidal symptoms (e.g., parkinsonism, dystonia), injection site reactions (e.g., pain).

Drug Interactions

Aripiprazole is extensively metabolized in the liver principally via dehydrogenation, hydroxylation, and N-dealkylation by CYP2D6 and CYP3A4.

Drugs Affecting Hepatic Microsomal Enzymes

Potent CYP3A4 inhibitors and/or potent CYP2D6 inhibitors: Potential pharmacokinetic interaction.

Combination of potent, moderate, and weak CYP3A4 and CYP2D6 inhibitors (e.g., potent CYP3A4 inhibitor with moderate CYP2D6 inhibitor; moderate CYP3A4 inhibitor with moderate CYP2D6 inhibitor): Potential pharmacokinetic interaction.

Potent CYP3A4 inducers: Decreased systemic exposure to aripiprazole.

Inhibitors or inducers of CYP isoenzymes 1A1, 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, or 2E1: Pharmacokinetic interaction unlikely.

Substrates of Hepatic Microsomal Enzymes

Substrates of CYP isoenzymes 2C9, 2C19, 2D6, and 3A4: Clinically important pharmacokinetic interaction unlikely; dosage adjustment not necessary.

Specific Drugs

Aripiprazole Pharmacokinetics

Absorption

Bioavailability

Absolute oral bioavailability of conventional tablets is 87%.

Peak plasma concentrations achieved within 3–5 hours after oral administration of conventional tablets; steady-state concentrations of aripiprazole and dehydro-aripiprazole achieved within 14 days.

Orally disintegrating tablets and conventional tablets are bioequivalent.

Well absorbed when administered as oral solution; plasma aripiprazole concentrations are higher after administration of oral solution than conventional tablets at equivalent doses. (See Dosage under Dosage and Administration.)

Oral solution-to-tablet ratios of geometric mean maximum plasma concentrations and AUCs were 122 and 114%, respectively.

Peak plasma concentrations following IM administration of immediate-release aripiprazole injection (no longer commercially available in the US) are 19% higher than those achieved following oral administration of conventional tablets. Systemic exposure over 24 hours is similar following IM and oral administration; however, AUC was 90% higher within first 2 hours after IM than after oral tablet administration.

Extended-release IM aripiprazole (Abilify Maintena): Peak plasma concentrations following multiple IM doses achieved within a median of 4 days with deltoid administration and 5–7 days with gluteal administration. Although single-dose IM administration into the deltoid results in 31% higher peak plasma concentrations compared with the gluteal site, extent of absorption similar for both injection sites. At steady state, AUCs and peak plasma concentrations similar for both deltoid and gluteal injection sites.

Extended-release IM aripiprazole lauroxil (Aristada): Following IM administration, aripiprazole appears in systemic circulation in 5–6 days and is continually released for an additional 36 days. Plasma concentrations of aripiprazole increase with consecutive doses and reach steady-state concentrations following the fourth monthly injection. When administered with oral aripiprazole for 21 days following the first injection, therapeutic plasma concentrations of aripiprazole achieved within 4 days. IM injection into the deltoid and gluteal areas results in similar systemic exposures; these injection sites are interchangeable. IM administration of 882 mg every 6 weeks or 1064 mg every 2 months results in plasma aripiprazole concentrations that are within the established therapeutic range for dosages of 441 and 882 mg once monthly.

Food

Administration of conventional tablets with a high-fat meal delayed rate but not extent of absorption.

Distribution

Extent

Large volume of distribution following IV administration indicates extensive extravascular distribution.

Distributed into milk.

Plasma Protein Binding

Aripiprazole and its major metabolite, dehydro-aripiprazole, are >99% bound, principally to albumin.

Elimination

Metabolism

Extensively metabolized in the liver principally via dehydrogenation, hydroxylation, and N-dealkylation by CYP2D6 and CYP3A4.

Extended-release IM aripiprazole lauroxil (Aristada): Aripiprazole lauroxil is a prodrug of aripiprazole and is probably converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole.

Elimination Route

Following oral administration, approximately 18% and <1% excreted unchanged in feces and urine, respectively; IM administration is not expected to alter metabolic pathways.

Half-life

Oral aripiprazole: 75 hours.

Dehydro-aripiprazole: 94 hours.

Extended-release aripiprazole (Abilify Maintena): Following multiple, once-monthly IM administration, about 30 days for the 300-mg dosage and 47 days for the 400-mg dosage.

Extended-release aripiprazole lauroxil (Aristada) administered IM monthly, every 6 weeks, or every 2 months: About 54–57 days.

Special Populations

Pediatric patients 10–17 years of age: Pharmacokinetics similar to those in adults after correcting for body weight differences.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C).

Orally Disintegrating Tablets

25°C (may be exposed to 15–30°C).

Tablets with Sensor

Tablets (i.e., Abilify MyCite tablets): 20–25°C (may be exposed to 15–30°C). Avoid exposure to humid conditions.

Wearable sensors (i.e., MyCite patch): 15–30°C and 15–93% relative humidity.

Oral Solution

25°C (may be exposed to 15–30°C). After opening, can use for up to 6 months (but not beyond expiration date).

Parenteral

Extended-release Aripiprazole (e.g., Abilify Maintena)

Prefilled dual-chamber syringe: <30°C. Do not freeze. Protect syringe from light; store in original package until time of use.

Vial: 25°C (may be exposed to 15–30°C).

Extended-release Aripiprazole Lauroxil (e.g., Aristada)

20–25°C (may be exposed to 15–30°C).

Extended-release Aripiprazole Lauroxil (e.g., Aristada Initio)

20–25°C (may be exposed to 15–30°C). Do not freeze.

Actions

• Exact mechanism of action in schizophrenia, bipolar disorder, major depressive disorder, irritability associated with autistic disorder, Tourette's syndrome, and agitation associated with schizophrenia or bipolar mania has not been fully elucidated; may involve the drug’s activity at dopamine D₂ and serotonin type 1 (5-HT_1A) and type 2 (5-HT_2A) receptors.

• Demonstrates partial agonist activity at D₂ and 5-HT_1A receptors and antagonist activity at 5-HT_2A receptors. The major active metabolite, dehydro-aripiprazole, exhibits affinity for D₂ receptors similar to that of the parent compound.

• Antagonism at other receptors (e.g., α₁-adrenergic receptors, histamine H₁ receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, somnolence).

Aripiprazole Tablets with Sensor

• Digital ingestion tracking system consists of aripiprazole tablets embedded with an ingestible sensor (Abilify MyCite), wearable sensor (MyCite patch), software application for mobile devices (MyCite App) for patients, and web-based portal for healthcare professionals and caregivers.

• Following oral administration of aripiprazole tablets with sensor, magnesium and cuprous chloride within the sensor react with gastric fluid to activate and power the sensor.

• Once activated, the ingestible sensor communicates with the wearable sensor within a 9-foot proximity using Bluetooth technology. The wearable sensor records the date and time of ingestions and transmits the data to the mobile software application. The mobile software application records and displays ingestion data for patients to review; subjective data such as activity level, mood, and quality of rest also may be reported to the software application.

• Healthcare professionals, caregivers, and/or family members may access ingestion data shared by the patient through a web-based portal or dashboard. The manufacturer states that this access is granted by the patient and may be withdrawn by the patient at any time.

Advice to Patients

• Importance of providing copy of written patient information (medication guide) each time aripiprazole is dispensed. Importance of advising patients to read the patient information before taking aripiprazole and each time the prescription is refilled.

• Importance of advising patients and caregivers that geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death. Inform patients and caregivers that aripiprazole is not approved for treating geriatric patients with dementia-related psychosis.

• Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, manic or hypomanic symptoms, irritability, agitation, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.

• Risk of somnolence and impairment of judgment, thinking, or motor skills; avoid driving, operating machinery, or performing hazardous tasks until effects on the individual are known.

• Importance of avoiding alcohol during extended-release IM aripiprazole (Abilify Maintena) therapy.

• Importance of informing patients and caregivers about the risk of NMS; importance of immediately contacting clinician or seeking emergency medical attention if signs and symptoms of this rare but potentially life-threatening syndrome develop (e.g., high fever, muscle stiffness, sweating, fast or irregular heart beat, change in BP, confusion, kidney damage).

• Importance of informing patients of risk of tardive dyskinesia if chronic use is contemplated. Importance of informing patients to report any muscle movements that cannot be stopped to a healthcare professional.

• Risk of leukopenia, neutropenia, and agranulocytosis. Importance of advising patients with a preexisting low WBC count or history of drug-induced leukopenia/neutropenia of need for CBC monitoring during aripiprazole therapy.

• Importance of informing patients about the risk of metabolic changes (e.g., hyperglycemia and diabetes mellitus, dyslipidemia, weight gain), how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring for such changes, including blood glucose, lipids, and weight, during therapy.

• Risk of pathological gambling and other compulsive behaviors. Advise patients and caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating, and/or other compulsive urges and the inability to control these urges during aripiprazole therapy. In some cases, but not all, the urges reportedly stopped when the dosage was reduced or the drug was discontinued. Advise patients or their caregivers to promptly report any such urges that seem out of the ordinary; also advise patients not to abruptly stop taking aripiprazole without first consulting their clinician.

• Risk of orthostatic hypotension and syncope, especially when initiating or reinitiating treatment or increasing the dosage.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., cardiovascular or cerebrovascular disease, diabetes mellitus, seizures).

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Importance of clinicians informing patients about the benefits and risks of taking antipsychotics during pregnancy, including that third trimester use of aripiprazole may cause extrapyramidal and/or withdrawal symptoms in a neonate, and about the pregnancy exposure registry (see Pregnancy under Cautions). Importance of advising patients not to stop taking aripiprazole if they become pregnant without consulting their clinician; abruptly discontinuing antipsychotic agents may cause complications. Importance of advising patients that aripiprazole can pass into breast milk and to consult with their clinician about the best way to feed their infant during aripiprazole therapy.

• Importance of avoiding overheating or dehydration.

• For patients taking aripiprazole orally disintegrating tablets, importance of not removing a tablet from the blister package until just before administering a dose; importance of peeling blister open with dry hands and placing tablet on tongue to dissolve and be swallowed with saliva.

• Importance of informing patients with phenylketonuria that aripiprazole orally disintegrating 10- and 15-mg tablets (Abilify Discmelt) contain 1.12 and 1.68 mg of phenylalanine, respectively.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Aripiprazole Tablets with Sensor

• Importance of instructing patients to download the MyCite App prior to initial use of aripiprazole tablets with sensor and ensure that the software is compatible with their mobile device (i.e., smart phone). Patients should refer to the information provided by the manufacturer and within the MyCite App for instructions regarding applying and changing the wearable sensor (i.e., MyCite patch) and pairing the wearable sensor to their mobile device. Advise patients that initial use of the MyCite system should be facilitated by a healthcare professional.

• Importance of advising patients that most ingestions of the tablets with sensor will be detected within 30 minutes; however, it may sometimes take >2 hours for the mobile device and web portal to detect ingestion, and, in some cases, ingestion may not be detected at all. Importance of not repeating a dose if the tablet with sensor is not detected after ingestion.

• Importance of advising patients that if their mobile device is lost, impaired, or otherwise rendered unusable, patients should change the wearable sensor immediately and connect to a new mobile device using their current account information. Inform patients that some data collected by the system may be lost; however, data previously synchronized to the patient's account will be available.

• Importance of informing patients that in order for the wearable sensor to communicate with the mobile device, the device must be powered on and Bluetooth-enabled. Importance of advising patients that the wearable sensor will communicate with a paired device when it is within a 9-foot proximity. Advise patients to keep the wearable sensor in place while showering, swimming, or exercising since it is intended to tolerate exposure to water and perspiration. However, the wearable sensor should be removed before magnetic resonance imaging (MRI) and replaced with a new wearable sensor as soon as possible following the MRI. Advise patients to remove the wearable sensor if skin irritation occurs. (See Tablets with Sensor [Abilify MyCite] under Dosage and Administration.)

• Importance of instructing patients to swallow aripiprazole tablets with sensor whole. Do not divide, crush, or chew the tablets.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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Frequently asked questions

• Why should you take aripiprazole in the morning?
• Does Abilify cause weight gain?
• What is the difference between Abilify and Abilify Maintena?
• How does Abilify MyCite work?

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