May 25, 2017
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Aripiprazole

Medical and Pharmacy Editor:

Brand Name: Abilify, Abilify Maintena, Aristada

Generic Name: Aripiprazole

Drug Class: Antipsychotics, 2nd Generation; Antimanic Agents

What Is Aripiprazole and How Does It Work?

Aripiprazole is a prescription medication used in treatment of schizophrenia, bipolar mania, and major depressive disorder.

Extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This medication can decrease hallucinations (hearing/seeing things that are not there) and improve your concentration. It also helps you to think more clearly, feel less nervous, and take a more active part in everyday life. Extended-release aripiprazole injection is a long-acting psychiatric medication known as an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain.

Aripiprazole is available under the following different brand names: Abilify, Abilify Maintena, and Aristada.

Dosages of Aripiprazole:

Adult and pediatric dosages:

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

Tablet, orally disintegrating

  • 2 tabs (6.78 mg) orally three times daily

Aripiprazole pallida root tincture

  • 10 mg
  • 15 mg

Oral solution

  • 1 mg/ml

Adult dosages only:

Extended-release injectable intermuscular suspension (Abilify Maintena)

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

Extended-release injectable intermuscular suspension (aripiprazole lauroxil [Aristada])

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

Injectable intermuscular solution

  • 7.5 mg/ml (9.75 mg/1.3 ml)

Dosage Considerations – Should be Given as Follows:

Schizophrenia

Adult Dosages

  • 10-15 mg/day orally initially, may be increased to 30 mg/day orally after 2 weeks

Maintenance with Abilify Maintena

  • 400 mg intramuscularly once monthly; continue treatment with aripiprazole orally (10-20 mg/day) or other oral antipsychotic for 14 consecutive days following first injection
  • Only to be administered by deep intermuscular 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 intermuscular plus oral aripiprazole 10-20 mg for 2 weeks

Aristada

  • Establish tolerability to aripiprazole with oral dosing, then in conjunction with the first Aristada dose, administer treatment with oral aripiprazole for 21 consecutive days
  • Depending on individual patient's needs, treatment can be initiated with 441 mg, 662 mg, or 882 mg intramuscularly 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 intramuscularly every 6 weeks
  • 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 oral dose
    • 10 mg/day orally: 441 mg intramuscularly once monthly
    • 15 mg/day orally: 662 mg intramuscularly once monthly
    • Over 20 mg/day: 882 mg intramuscularly once monthly

Pediatric Dosages

  • 13-17 years: 2 mg/day orally 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

Adult Dosages

  • 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 orally initially; may be increased gradually; not to exceed 30 mg/day
  • Adjunct to lithium or valproate: 10-15 mg/day orally 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 over 6 weeks not studied

Pediatric Dosages

  • Acute manic or mixed episodes, either as monotherapy or as adjunct to lithium or valproate
  • Children 10-17 years: 2 mg/day orally 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

Major Depressive Disorder

Adult Dosages

  • 2-5 mg/day orally initially; increased weekly as needed by over or equal to 5 mg/day to dose range of 2-15 mg/day
  • Used adjunctively with other antidepressants

Dosage Modifications (Oral)

Adult Dosages

  • 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 (decrease dose by 75%)
  • Coadministration with any CYP2D6 inhibitor PLUS any CYP3A4 inhibitor: Decrease dose to 25% of the usual dose (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 (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)

Adult Dosages

  • CYP2D6 poor metabolizers: 300 mg intramuscularly
  • CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitor: 200 mg intramuscularly

Patients taking 400 mg intramuscularly

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

Patients taking 300 mg intramuscularly

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

Missed doses

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

Dosage Modifications (Aristada)

Adult Dosages

  • No dosage changes if CYP450 modulators are added for less than 2 weeks
  • Strong CYP3A4 inhibitor for over 2 weeks
  • 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 more than 2 weeks
  • 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 and CYP2D6 inhibitors for over 2 weeks
  • Avoid use for patients taking 662 mg or 882 mg
  • No dosage adjustment necessary in patients taking 441 mg, if tolerated
  • CYP3A4 inducers for over 2 weeks
  • 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 weeks
  • See the following for recommendations for missed doses based on last injection dose

Monthly 441 mg

  • Up to 6 weeks: No oral supplementation required
  • Over 6 weeks and up to 7 weeks: Supplement with 7 days of oral aripiprazole
  • Over 7 weeks: Supplement with 21 days of oral aripiprazole
  • Monthly 662 mg, monthly 882 mg, or 882 mg every 6 weeks
  • Up to 8 weeks: No oral supplementation required
  • Over 8 weeks and up to 12 weeks: Supplement with 7 days of oral aripiprazole
  • Over 12 weeks: Supplement with 21 days of oral aripiprazole

Autism

Pediatric Dosages

  • Irritability associated with autistic disorder
  • Children under 6 years: Safety and efficacy not established
  • Children 6-17 years: 2 mg/day orally initially; increased gradually at intervals over or 1 week to target dosage of 5 mg/day; may gradually be further increased as needed to 10 mg/day or higher; not to exceed 15 mg/day

Tourette Disorder

Pediatric Dosages

Indicated for treatment of Tourette disorder

  • Children under 6 years: Safety and efficacy not established
  • Children 6-18 years (less than 50 kg)

Initiate at 2 mg/day orally 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

Children 6-18 years (over or 50 kg)

  • Initiate at 2 mg/day orally 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)

Pediatric Dosage

  • 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 (decrease dose by 75%)
  • Coadministration with any CYP2D6 inhibitor PLUS any CYP3A4 inhibitor: Decrease dose to 25% of the usual dose (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 (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
Medically Reviewed by a Doctor on 5/17/2017



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