aripiprazole (Rx)

Brand and Other Names:Abilify, Abilify Maintena, more...Aristada
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 2mg
  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 30mg

oral disintegrating tablet

  • 10mg
  • 15mg

oral solution

  • 1mg/mL

extended-release injectable IM suspension (Abilify Maintena)

  • 300mg/vial or prefilled dual chamber syringe
  • 400mg/vial or prefilled dual chamber syringe

extended-release injectable IM suspension (aripiprazole lauroxil [Aristada])

  • 441mg/prefilled syringe
  • 662mg/prefilled syringe
  • 882mg/prefilled syringe

injectable IM solution

  • 7.5mg/mL (9.75mg/1.3mL)
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Schizophrenia

10-15 mg/day PO initially; may be increased to 30 mg/day PO after 2 weeks

Maintenance with Abilify Maintena

  • Abilify Maintena: 400 mg IM once monthly; continue treatment with aripiprazole PO (10-20 mg/day) or other oral antipsychotic for 14 consecutive days following first injection
  • Only to be administered by deep IM injection into deltoid or gluteal muscle by healthcare professional
  • Establish tolerability with oral aripiprazole prior to initiating if patient has never taken aripiprazole
  • Administer monthly dose no sooner than 26 days after previous injection (also see Dosage Modifications)
  • Consider dose reduction to 300 mg/month if adverse reaction occurs

Treatment of relapse with Abilify Maintena

  • 400 mg IM plus oral aripiprazole 10-20 mg x2 weeks

Aristada

  • Establish tolerability to aripiprazole with oral dosing, then in conjunction with the first Aristada dose, administer treatment with PO aripiprazole for 21 consecutive days
  • Depending on individual patient’s needs, treatment can be initiated with 441 mg, 662 mg, or 882 mg IM once monthly of Aristada, which corresponds to 300 mg, 450 mg, and 600 mg of aripiprazole base, respectively
  • Treatment may also be initiated with 882 mg IM q6wk
  • Adjust dose and dosing interval as needed; take into consideration the pharmacokinetics and prolonged-release characteristics of Aristada
  • In the event of early dosing, Aristada should not be given earlier than 14 days after the previous injection
  • Aristada dose based on total PO dose
    • 10 mg/day PO: 441 mg IM once monthly
    • 15 mg/day PO: 662 mg IM once monthly
    • ≥20 mg/day: 882 mg IM once monthly

Bipolar Mania

Acute and maintenance treatment of manic or mixed episodes associated with bipolar I disorder, either as monotherapy or as adjunct to lithium or valproate

Monotherapy: 15 mg/day PO initially; may be increased gradually; not to exceed 30 mg/day

Adjunct to lithium or valproate: 10-15 mg/day PO initially; recommended daily dose is 15 mg/day; may be gradually increased; not to exceed 30 mg/day

Continue stabilization dose for up to 6 weeks; treatment >6 weeks not studied

Major Depressive Disorder

2-5 mg/day PO initially; increased weekly PRN by ≤5 mg/day to dose range of 2-15 mg/day

Used adjunctively with other antidepressants

Dosage Modifications (Oral)

Coadministration with potent CYP2D6 or CYP3A4 inhibitors: Decrease dose by 50%

Coadministration with potent CYP2D6 inhibitor PLUS a potent CYP3A4 inhibitor: Decrease dose to 25% of the usual dose (ie, decrease dose by 75%)

Coadministration with any CYP2D6 inhibitor PLUS any CYP3A4 inhibitor: Decrease dose to 25% of the usual dose (ie, decrease dose by 75%) initially, and then adjust to a favorable clinical response

Poor CYP2D6 metabolizers: Decrease dose by 50% initially, and then adjust to a favorable clinical response

Poor CYP3A4 metabolizers: Decrease dose to 25% of the usual dose (ie, decrease dose by 75%) initially, and then adjust to a favorable clinical response

Coadministration with potent CYP3A4 inducer: The usual dose should be doubled

Dosage Modifications (Abilify Maintena)

CYP2D6 poor metabolizers: 300 mg IM

CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitor: 200 mg IM

Patients taking 400 mg IM

  • Strong CYP2D6 OR CYP3A4 inhibitors: 300 mg IM
  • CYP2D6 AND CYP 3A4 inhibitors: 200 mg IM
  • CYP3A4 inducers: Avoid use

Patients taking 300 mg IM

  • Strong CYP2D6 OR CYP3A4 inhibitors: 200 mg IM
  • CYP2D6 AND CYP 3A4 inhibitors: 160 mg IM
  • CYP3A4 inducers: Avoid use

Missed doses

  • 2nd or 3rd dose missed (>4 wk but <5 wk since last injection): Administer injection as soon as possible
  • 2nd or 3rd dose missed (>5 wk since last injection): Restart concomitant oral aripiprazole for 14 days with next administered injection
  • 4th or subsequent doses missed (>4 wk but <6 wk since last injection): Administer injection as soon as possible
  • 4th or subsequent doses missed (>6 wk since last injection): Restart concomitant oral aripiprazole for 14 days with next administered injection

Dosage Modifications (Aristada)

No dosage changes if CYP450 modulators are added for <2 wk

Strong CYP3A4 inhibitor for >2 wk

  • Reduce the dose to the next lower strength No dosage adjustment necessary in patients taking 441 mg, if tolerated
  • Poor CYP2D6 metabolizers: Reduce dose to 441 mg from 662 mg or 882 mg; no dosage adjustment necessary in patients taking 441 mg, if tolerated

Strong CYP2D6 inhibitor for >2 wk

  • Reduce the dose to the next lower strength
  • No dosage adjustment necessary in patients taking 441 mg, if tolerated
  • Poor CYP2D6 metabolizers: No dose adjustment required

Both strong CYP3A4 & CYP2D6 inhibitors for >2 wk

  • Avoid use for patients taking 662 mg or 882 mg
  • No dosage adjustment necessary in patients taking 441 mg, if tolerated

CYP3A4 inducers for >2 wk

  • No dose adjustment for 662 mg and 882 mg dose
  • Increase the 441 mg dose to 662 mg

Missed doses

  • When a dose is missed, administer the next injection as soon as possible, unless the time has exceed 6-8 wk
  • See the following for recommendations for missed doses based on last injection dose
  • Monthly 441 mg
    • ≤6 wk: No PO supplementation required
    • >6 wk and ≤7 wk: Supplement with 7 days of PO aripiprazole
    • >7 wk: Supplement with 21 days of PO aripiprazole
  • Monthly 662 mg, monthly 882 mg, or 882 mg q6wk
    • ≤8 wk: No PO supplementation required
    • >8 wk and ≤12 wk: Supplement with 7 days of PO aripiprazole
    • >12 wk: Supplement with 21 days of PO aripiprazole

Dosing Considerations

Dosing for oral disintegrating tablets is the same as for oral tablets

Dosage Forms & Strengths

tablet

  • 2mg
  • 5mg
  • 10mg
  • 15mg
  • 20mg
  • 30mg

tablet, orally disintegrating

  • 10mg
  • 15mg

oral solution

  • 1mg/mL
more...

Schizophrenia

13-17 years: 2 mg/day PO initially; increased to 5 mg/day after 2 days; increased to recommended dosage of 10 mg/day after additional 2 days; may subsequently be increased by 5 mg/day; maintenance: 10-30 mg/day

Bipolar Mania

Acute manic or mixed episodes, either as monotherapy or as adjunct to lithium or valproate

10-17 years: 2 mg/day PO initially; increased to 5 mg/day after 2 days; increased to recommended dosage of 10 mg/day after additional 2 days; may subsequently be increased by 5 mg/day; maintenance: 10-30 mg/day

Autism

Irritability associated with autistic disorder

<6 years: Safety and efficacy not established

6-17 years: 2 mg/day PO initially; increased gradually at intervals ≥1 week to target dosage of 5 mg/day; may gradually be further increased PRN to 10 mg/day or higher; not to exceed 15 mg/day

Tourette Disorder

Indicated for treatment of Tourette disorder

<6 years: Safety and efficacy not established

6-18 years (<50 kg)

  • Initiate at 2 mg/day PO with a target dose of 5 mg/day after 2 days
  • The dose can be increased to 10 mg/day in patients who do not achieve optimal control of tics
  • Dosage adjustments should occur gradually at intervals of no less than 1 week

6-18 years (≥50 kg)

  • Initiate at 2 mg/day PO for 2 days, and then increase to 5 mg/day for 5 days, with a target dose of 10 mg/day on day 8
  • The dose can be increased up to 20 mg/day for patients who do not achieve optimal control of tics
  • Dosage adjustments should occur gradually in increments of 5 mg/day at intervals of no less than 1 week

Dosage Modifications (Oral)

Coadministration with potent CYP2D6 or CYP3A4 inhibitors: Decrease dose by 50%

Coadministration with potent CYP2D6 inhibitor PLUS a potent CYP3A4 inhibitor: Decrease dose to 25% of the usual dose (ie, decrease dose by 75%)

Coadministration with any CYP2D6 inhibitor PLUS any CYP3A4 inhibitor: Decrease dose to 25% of the usual dose (ie, decrease dose by 75%) initially, and then adjust to a favorable clinical response

Poor CYP2D6 metabolizers: Decrease dose by 50% initially, and then adjust to a favorable clinical response

Poor CYP3A4 metabolizers: Decrease dose to 25% of the usual dose (ie, decrease dose by 75%) initially, and then adjust to a favorable clinical response

Coadministration with potent CYP3A4 inducer: The usual dose should be doubled

Dosing Considerations

Dosing for oral disintegrating tablets is the same as for oral tablets

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Interactions

Interaction Checker

and aripiprazole

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            Adverse Effects

            >10%

            Weight gain (8-30%)

            Headache (27%)

            Agitation (19%)

            Insomnia (18%)

            Anxiety (17%)

            Nausea and vomiting (11-15%)

            Akathisia (10-13%)

            Lightheadedness (11%)

            Constipation (10-11%)

            1-10%

            Dizziness (10%)

            Dyspepsia (9%)  

            Somnolence (5-8%)

            Fatigue (6%) 

            Restlessness (6%)

            Tremor (6%)

            Dry mouth/xerostomia (5%) 

            Extrapyramidal disorder (5%) 

            Orthostatic hypotension (1-5%)

            Musculoskeletal stiffness (4%)

            Abdominal discomfort (3%) 

            Blurred vision (3%) 

            Cough (3%) 

            Pain (3%)

            Myalgia (2%) 

            Rash  

            Rhinitis  

            <1%

            Altered mental status

            Autonomic instability

            Dysphagia

            Hyperpyrexia

            Muscle rigidity

            Neuroleptic malignant syndrome (NMS)

            Seizure

            Tardive dyskinesia

            Postmarketing Reports

            Pathological gambling

            Hiccups

            Falls

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            Warnings

            Black Box Warnings

            Not approved for dementia-related psychosis; patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths reported in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

            In short-term studies, antidepressants increased risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses

            Contraindications

            Documented hypersensitivity

            Cautions

            Risk of NMS and extrapyramidal symptoms (EPS)

            Tardive dyskinesia may occur; may consider discontinuation of therapy if clinically indicated

            May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; perform complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy

            Use caution in patients with known cardiovascular disease, cerebrovascular disease, or predisposition to hypotension; may increase incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities)

            Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope

            Use caution in patients with Parkinson disease; may aggravate motor disturbances

            May increase risk of suicidal tendencies in children and adolescents

            FDA warning regarding off-label use for dementia in elderly

            Patients may act on dangerous impulses

            Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia

            If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/mcL in absence of other causative factors, and continue monitoring WBC count until recovery

            Monitor for orthostatic hypertension

            May cause seizures or convulsions; use cautiously in patients with history of seizures or with conditions that lower the seizure threshold

            May cause CNS depression, which may impair physical or mental abilities; use caution when operating heavy machinery

            Use caution in patients at risk of pneumonia; antipsychotic therapy has been associated with esophageal dysmotility and aspiration

            Impairment of core body temperature regulation possible; use caution in dehydration, heat exposure, strenuous exercise, and concomitant medication possessing anticholinergic effects

            Metabolic changes

            • Atypical antipsychotics have been associated with metabolic changes that may increase cardiovascular or cerebrovascular risk, including dyslipidemia and body weight gain
            • Increased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death; monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness; monitor glucose regularly in patients with and at risk for diabetes
            • Significant weight gain reported with therapy; monitor waist circumference and BMI
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            Pregnancy & Lactation

            Pregnancy category: C

            Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for EPS or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization

            Lactation: Excreted in human breast milk; a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Atypical antipsychotic; partial agonist at dopamine D2 and serotonin type 1 (5-HT1A) receptors; antagonist at serotonin type 2 (5-HT2A) receptor; also has alpha-blocking activity

            Absorption

            Bioavailability: 87% (tablet); 100% (IM)

            Peak plasma time: 1-3 hr (IR); 5-7 hr (ER); 3-5 hr (tablet)

            Distribution

            Protein bound: 99%

            Vd: 404 L (4.9 L/kg)

            Metabolism

            Metabolized by CYP2D6 and CYP3A4

            Metabolites: Dehydroaripiprazole (40%)

            Elimination

            Half-life: 75 hr (parent drug); 94 hr (metabolite); 30-47 days (IM); 146 hr (poor metabolizers)

            Excretion: Feces (55%), urine (25%)

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            Administration

            IM Preparation (Abilify Maintena)

            Do not confuse IM long-acting depot suspension for maintenance of schizophrenia with the IM solution for acute agitation in patients with schizophrenia or mania

            Reconstitute lyophilized power with sterile water for injection (SWI); discard any unused portion of diluent

            400 mg/vial: 1.9 mL SWI

            300 mg/vial: 1.5 mL SWI

            Final concentration for either vial is 200 mg/mL following reconstitution

            Slowly inject SWI into vial, and then withdraw air from vial to equalize the pressure

            Shake the vial vigorously for 30 seconds until the reconstituted suspension appears uniform

            Visually inspect for particulate matter and discoloration; should appear as a uniform, homogeneous suspension that is opaque and milky-white in color

            Do not store reconstituted suspension in syringe

            Use BD Leur-Lok syringe (provided in kit) to remove the vial adapter from the package and discard the vial adapter package

            Determine recommended volume for injection to provide appropriate dose

            Attach adapter-syringe to vial and pushing adapter’s spike firmly through the rubber stopper until it snaps in place

            Slowly withdraw the dosage volume into the syringe

            Remove BD Leur-Lok syringe and select appropriate size hypodermic needle

            Needle for gluteal injection

            • Nonobese patient: 22-ga, 1.5-in
            • Obese patient: 21-ga, 2-in

            Needle for deltoid injection

            • Nonobese patient: 23-ga, 1-in
            • Obese patient: 22-ga, 1.5-in

            IM Preparation (Aristada)

            Tap the syringe on your palm at least 10 times to dislodge any material which may have settled, and then shake the syringe vigorously for a minimum of 30 seconds to ensure a uniform suspension; if the syringe is not used within 15 minutes, shake again for 30 seconds

            Select injection need according to injection site

            • 441 mg dose (deltoid): 21-ga, 1-in or 20-ga, 1.5-in
            • 441 mg, 662 mg, or 882 mg doses (gluteal): 20-ga, 1.5-in or 20-ga 2-in

            Attach appropriate needle with a clockwise twisting motion; do not overtighten (could lead to needle hub cracking)

            Prime syringe to remove air by bringing the syringe into upright position and tap the syringe to bring air to the top; remove air by depressing the plunger rod; a few drops of suspension will be released

            Administer the entire content IM; inject in a rapid and continuous manner in <10 seconds

            Cover the needle by pressing the safety device, then dispose the needle, and used and unused items in proper waste container

            IM Administration

            Must be administered by a healthcare professional

            For IM use only; do not administer IV or SC

            Abilfy Maintena

            • Slowly inject dosage volume as a single IM injection into the deltoid or gluteal muscle
            • Do not massage the injection site

            Aristada

            • Administer the entire syringe content IM; inject in a rapid and continuous manner in <10 seconds
            • 441 mg once monthly: Administer in deltoid or gluteal muscle
            • 662 mg monthly, 882 mg monthly or q6wk: Administer in gluteal muscle
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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