Abilify Asimtufii

— THERAPEUTIC CATEGORIES —
  • Mood disorders
  • Psychosis
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Abilify Asimtufii Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Aripiprazole 720mg/2.4mL, 960mg/3.2mL; ext-rel susp for IM inj.

    Pharmacological Class

    Atypical antipsychotic.

    See Also

      How Supplied

      Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier; MyCite kits (1-component patch)—30 tabs + 7 patches; MyCite kits (2-component patch)—Starter kit (30 tabs + 1 pod + 7 strips); Maintenance kit (30 tabs + 7 strips); Asimtufii kit—1

      Manufacturer

      Otsuka America Pharmaceutical, Inc.

      Generic Availability

      Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite, Asimtufii (NO)

      Mechanism of Action

      The mechanism of action of aripiprazole in the treatment of schizophrenia, bipolar I disorder, or adjunctive treatment of major depressive disorder is unknown.

      Abilify Asimtufii Indications

      Indications

      Maintenance treatment of bipolar I disorder as monotherapy.

      Abilify Asimtufii Dosage and Administration

      Adult

      Treatment-naive: establish tolerability with oral form first. Give by IM inj into the gluteal muscle. 960mg once every 2 months (56 days after previous inj). After first Asimtufii dose, continue with concurrent oral aripiprazole (10–20mg) or other antipsychotic for 14 consecutive days. Patients receiving Abilify Maintena: 960mg once every 2 months; may administer in place of next scheduled inj; reduce to 720mg once every 2 months if adverse reactions occur. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.

      Children

      Not established.

      Abilify Asimtufii Contraindications

      Not Applicable

      Abilify Asimtufii Boxed Warnings

      Boxed Warning

      Increased mortality in elderly patients with dementia-related psychosis.

      Abilify Asimtufii Warnings/Precautions

      Warnings/Precautions

      Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA).  Cardio- or cerebrovascular disease. Risk of neuroleptic malignant syndrome (discontinue if suspected), hypotension, aspiration, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; consider discontinuation if clinically significant decline in WBC occurs. Discontinue if severe neutropenia occurs (ANC <1000/mm3). Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. CYP2D6 poor metabolizers. Reevaluate periodically. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

      Abilify Asimtufii Pharmacokinetics

      Metabolism

      Hepatic (CYP2D6, CYP3A4). >99% serum protein bound. 

      Elimination

      Fecal (primary), renal. 

      Abilify Asimtufii Interactions

      Interactions

      See Adult. Potentiated by CYP3A4 inhibitors  or CYP2D6 inhibitors. Antagonized by CYP3A4 inducers (eg, carbamazepine); avoid use for >14 days. Potentiates antihypertensives; monitor BP and adjust dose as needed. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

      Abilify Asimtufii Adverse Reactions

      Adverse Reactions

      Increased weight, akathisia, inj site pain, sedation; neuroleptic malignant syndrome, tardive dyskinesia (consider discontinuation if occurs), weight gain, hyperglycemia, dyslipidemia, others. 

      Abilify Asimtufii Clinical Trials

      See Literature

      Abilify Asimtufii Note

      Notes

      Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

      Abilify Asimtufii Patient Counseling

      See Literature

      Abilify Asimtufii Generic Name & Formulations

      Legal Class

      Rx

      General Description

      Aripiprazole 720mg/2.4mL, 960mg/3.2mL; ext-rel susp for IM inj.

      Pharmacological Class

      Atypical antipsychotic.

      See Also

      How Supplied

      Tabs 2mg—30; 5mg, 10mg, 15mg, 20mg, 30mg—30, 100; Prefilled Dual Chamber Syringe—1 (w. supplies); Single-use vials—1 (w. supplies); Oral soln, orally disintegrating tabs—contact supplier; MyCite kits (1-component patch)—30 tabs + 7 patches; MyCite kits (2-component patch)—Starter kit (30 tabs + 1 pod + 7 strips); Maintenance kit (30 tabs + 7 strips); Asimtufii kit—1

      Manufacturer

      Otsuka America Pharmaceutical, Inc.

      Generic Availability

      Tabs, soln, orally disintegrating tabs (YES); Maintena, MyCite, Asimtufii (NO)

      Mechanism of Action

      The mechanism of action of aripiprazole in the treatment of schizophrenia, bipolar I disorder, or adjunctive treatment of major depressive disorder is unknown.

      Abilify Asimtufii Indications

      Indications

      Schizophrenia. 

      Abilify Asimtufii Dosage and Administration

      Adult

      Treatment-naive: establish tolerability with oral form first. Give by IM inj into the gluteal muscle. 960mg once every 2 months (56 days after previous inj). After first Asimtufii dose, continue with concurrent oral aripiprazole (10–20mg) or other antipsychotic for 14 consecutive days. Patients receiving Abilify Maintena: 960mg once every 2 months; may administer in place of next scheduled inj; reduce to 720mg once every 2 months if adverse reactions occur. Dose adjustments for missed dose, CYP2D6 poor metabolizers, concomitant CYP2D6 inhibitors, CYP3A4 inhibitors or inducers for >14 days: see full labeling.

      Children

      Not established.

      Abilify Asimtufii Contraindications

      Not Applicable

      Abilify Asimtufii Boxed Warnings

      Boxed Warning

      Increased mortality in elderly patients with dementia-related psychosis.

      Abilify Asimtufii Warnings/Precautions

      Warnings/Precautions

      Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA).  Cardio- or cerebrovascular disease. Risk of neuroleptic malignant syndrome (discontinue if suspected), hypotension, aspiration, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; consider discontinuation if clinically significant decline in WBC occurs. Discontinue if severe neutropenia occurs (ANC <1000/mm3). Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Suicidal tendencies. Pathological gambling and other compulsive behaviors: consider dose reduction or discontinuation if develops. CYP2D6 poor metabolizers. Reevaluate periodically. Write ℞ for smallest practical amount. Labor & delivery. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

      Abilify Asimtufii Pharmacokinetics

      Metabolism

      Hepatic (CYP2D6, CYP3A4). >99% serum protein bound. 

      Elimination

      Fecal (primary), renal. 

      Abilify Asimtufii Interactions

      Interactions

      See Adult. Potentiated by CYP3A4 inhibitors  or CYP2D6 inhibitors. Antagonized by CYP3A4 inducers (eg, carbamazepine); avoid use for >14 days. Potentiates antihypertensives; monitor BP and adjust dose as needed. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

      Abilify Asimtufii Adverse Reactions

      Adverse Reactions

      Increased weight, akathisia, inj site pain, sedation; neuroleptic malignant syndrome, tardive dyskinesia (consider discontinuation if occurs), weight gain, hyperglycemia, dyslipidemia, others. 

      Abilify Asimtufii Clinical Trials

      See Literature

      Abilify Asimtufii Note

      Notes

      Register patients in National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

      Abilify Asimtufii Patient Counseling

      See Literature

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