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ABILIFY MYCITE
Mood disorders
Psychosis
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Drug Name:

ABILIFY MYCITE Rx

Generic Name and Formulations:
Aripiprazole 2mg, 5mg, 10mg, 15mg, 20mg, 30mg; tabs with ingestible event marker (IEM) sensor.

Company:
Otsuka America Pharmaceutical, Inc.

Therapeutic Use:

Indications for ABILIFY MYCITE:

Acute and maintenance treatment of manic or mixed episodes in bipolar I disorder as monotherapy; or as an adjunct to lithium or valproate. Adjunct to antidepressants for major depressive disorder (MDD).

Limitations Of use:

Ability to improve patient compliance or modify dosage has not been established. Use for real-time drug ingestion tracking or use during emergency is not recommended.

Adult:

Swallow tabs whole. Apply MyCite Patch just above lower edge of left rib cage; change weekly or sooner as needed. Bipolar disorder: initially 15mg once daily; may increase to max 30mg/day; adjunct to lithium or valproate: 10–15mg/day; max 30mg/day. Adjunct for MDD: initially 2–5mg/day; may adjust by 5mg/day increments at intervals of ≥1 week; usual range: 2–15mg/day. Concomitant strong CYP3A4 or CYP2D6 inhibitors, or CYP2D6 poor metabolizer: reduce aripiprazole dose by ½. Concomitant strong CYP3A4 inducers: double aripiprazole dose (max 30mg/day) over 1–2 weeks. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.

Children:

Not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. 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: not recommended.

See Also:

ABILIFY

Aripiprazole Oral Solution

Aripiprazole Orally Disintegrating Tablets

ABILIFY MAINTENA

Pharmacological Class:

Atypical antipsychotic.

Interactions:

See Adult. Potentiated by CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Antagonized by CYP3A4 inducers (eg, carbamazepine, rifampin). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

Adverse Reactions:

Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

Note:

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

Generic Availability:

NO

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—30 tabs + 7 patches

Indications for ABILIFY MYCITE:

Schizophrenia.

Limitations Of use:

Ability to improve patient compliance or modify dosage has not been established. Use for real-time drug ingestion tracking or use during emergency is not recommended.

Adult:

Swallow tabs whole. Apply Mycite Patch just above lower edge of left rib cage; change weekly or sooner as needed. Initially 10mg or 15mg once daily; may increase after at least 2 weeks; usual range 10–15mg/day; max 30mg/day. Concomitant strong CYP3A4 or CYP2D6 inhibitors, or CYP2D6 poor metabolizer: reduce aripiprazole dose by ½. Concomitant strong CYP3A4 inducers: double aripiprazole dose (max 30mg/day) over 1–2 weeks. Adjust dose to normal range when these drugs are withdrawn. Other dose adjustments: see full labeling.

Children:

Not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors with antidepressant drugs.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Cardio- or cerebrovascular disease. Risk of hypotension, aspiration pneumonia, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Exclude neuroleptic malignant syndrome if fever occurs. 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: not recommended.

See Also:

ABILIFY

Aripiprazole Oral Solution

Aripiprazole Orally Disintegrating Tablets

ABILIFY MAINTENA

Pharmacological Class:

Atypical antipsychotic.

Interactions:

See Adult. Potentiated by CYP3A4 inhibitors (eg, itraconazole, clarithromycin) or CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Antagonized by CYP3A4 inducers (eg, carbamazepine, rifampin). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics). Monitor with lorazepam.

Adverse Reactions:

Headache, anxiety, insomnia, constipation, nausea, vomiting, somnolence, fatigue, sedation, dizziness, restlessness, akathisia, orthostatic hypotension, blurred vision, tremor, pyrexia, salivary hypersecretion, nasopharyngitis, EPS, neuroleptic malignant syndrome, tardive dyskinesia, weight gain, hyperglycemia, dyslipidemia, others. Inj: local reactions.

Note:

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

Generic Availability:

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

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—30 tabs + 7 patches

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