Names and pronunciation
(a-rip-ip-pra′zol) Abilify, Abilify Discmelt, Abilify Maintena, Abilify MyCite Aristada, Aristada Initio
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Drug reference
(a-rip-ip-pra′zol) Abilify, Abilify Discmelt, Abilify Maintena, Abilify MyCite Aristada, Aristada Initio
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Func. class.: Antipsychotic
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Chem. class.: Quinolinone
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Do not confuse: ARIPiprazole/RABEprazole
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ACTION: Exact mechanism unknown; may be mediated through both DOPamine type 2 (D2, D3) and serotonin type 2 (5-HT1A, 5-HT2A) antagonism, DOPamine system stabilizer
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USES: Schizophrenia and bipolar disorder (adults and adolescents), mania, major depressive disorder, short-term mania or mixed episodes of bipolar disorder; irritability in patients with autism
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CONTRAINDICATIONS: Breast- feeding, hypersensitivity, seizure disorders Precautions: Pregnancy, geriatric patients, renal/hepatic/cardiac disease, neutropenia
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Black Box Warning: Children with de- pression; suicidal ideation; dementia Black Box Warning: Mental status be- fore initial use; children/young adults may exhibit suicidal thoughts/behav- iors; smallest amount of product should be given; elderly with dementia-related psychosis are at increased risk of death • AIMS assessment, neurologic func- tion, LFTs, weight, lipid profile, blood glucose monthly • Affect, orientation, LOC, reflexes, gait, coordination, sleep pattern disturbances • B/P standing and lying; also pulse, respirations; take q4hr during initial treatment; establish baseline before start- ing treatment; report drops of 30 mm Hg; watch for ECG changes • Dizziness, faintness, palpitations, tachycardia on rising • EPS, including akathisia (inability to sit still, no pattern to movements), tar- dive dyskinesia (bizarre movements of the jaw, mouth, tongue, extremities), pseudoparkinsonism (rigidity, tremors, pill rolling, shuffling gait) • Neuroleptic malignant syndrome: hyperthermia, increased CPK, altered mental status, muscle rigidity; notify pre- scriber immediately • Beers: avoid in older adults, high risk of delirium, CVA; may use in schizophre- nia, bipolar disorder, or short-term as antiemetic in chemotherapy Black Box Warning: To report suicidal thoughts/behaviors, dementia immediately • Pregnancy/breastfeeding: Identify if pregnancy is planned or suspected; pregnant patient should be enrolled in the National Pregnancy Registry for Atypical Antipsychot- ics 866-961-2388; avoid breastfeeding; use only if benefits outweigh fetal risk
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SIDE EFFECTS CNS: Drowsiness, insomnia, agitation, anxiety, headache, seizures, neuroleptic malignant syndrome, lightheadedness, akathisia, tremor, suicidal ideation, tar- dive dyskinesia, EPS CV: Orthostatic hypotension, tachycardia, chest pain, hypertension, peripheral edema EENT: Blurred vision, rhinitis GI: Constipation, nausea, vomiting, weight gain INTEG: Rash, dry skin, sweating META: Hyperglycemia MS: Myalgia RESP: Cough, dyspnea, hypercholester- olemia HEMA: Agranulocytosis, anemia, leukemia SYST: Death among geriatric patients with dementia, hypersensitivity
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INTERACTIONS Increase: effects of ARIPiprazole— CYP3A4 inhibitors (ketoconazole, eryth- romycin), CYP2D6 inhibitors (quiNI- Dine, FLUoxetine, PARoxetine); reduce dose of ARIPiprazole Increase: sedation—other CNS depres- sants, alcohol Increase: EPS—other antipsychotics, lithium Decrease: ARIPiprazole level—famoti- dine, valproate Decrease: effects of ARIPiprazole— CYP3A4 inducers (carBAMazepine); dose of ARIPIprazole may need to be increased Increase: antihypertensive effect—anti- hypertensives; monitor B/P Drug/Herb Decrease: ARIPiprazole effect—St. John’s wort Drug/Lab False positive: amphetamine drug screen
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TREATMENT OF OVERDOSE: Lavage if orally ingested; provide airway; do not induce vomiting
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DOSAGE AND ROUTES Major depressive disorder • Adult: PO 2-5 mg/day as an adjunct to other antidepressant treatment; adjust by 5 mg at ≥1 wk (range, 2-15 mg/day) Schizophrenia (Abilify Maintena PO/IM) • Adult: PO 10-15 mg/day; if needed, dosage may be increased to 30 mg/day after 2 wk; maintenance 15 mg/day; peri- odically reassess; IM/extended release (monthly injection suspension) 400 mg monthly • Adolescent 13-17 yr: PO 2 mg/day, may increase to 5 mg after 2 days, then 10 mg after 2 more days, max 30 mg/day Schizophrenia (Aristada/Aristada INITIO) • Use PO first before using these prod- ucts to raise tolerability to product • May give IM 1 dose of Aristada INITIO 675 mg (in either deltoid or gluteal muscle) and 1 dose of PO ARIPiprazole 30 mg with the first Aristada injection • The first Aristada injection may be given on the same day as Aristada INITIO or up to 10 days after • Avoid injecting both Aristada INITIO and Aristada concomitantly into the same site OR • Give 21 consecutive days of PO AR- IPiprazole with the first Aristada injection • Depending on individual patient’s needs, treatment with Aristada can be initiated at a dose of 441 mg (monthly in deltoid or gluteal), 662 mg (monthly in gluteal), or 882 mg (monthly or every 6 wk in gluteal) or 1064 mg (every 2 mo in gluteal). The 441-mg, 662-mg, 882-mg, and 1064-mg doses correspond to 300 mg, 450 mg, 600 mg, and 724 mg of ARIPiprazole, respectively Schizophrenia, bipolar disorder • Adult: PO 15 mg/day, may increase to 30 mg if needed (monotherapy); adjunc- tive to lithium or valproate PO 10-15 mg daily, may increase to 30 mg if needed • Child >10 yr, adolescent: PO 2 mg, titrate to 5 mg/day after 2 days to target of 10 mg/day after another 2 days Agitation with bipolar disorder/ schizophrenia • Adult: IM 9.75 mg as a single dose, may start with a lower dose, max 30 mg/day Irritability associated with autism • Child ≥6 yr, adolescent: PO 2 mg/day, increase to 5 mg/day after 1 wk, may in- crease to 10-15 mg/day if needed; dose changes should not occur more frequently than q1wk Tourette’s syndrome • Child 6-18 yr ≥50 kg: PO 2 mg/day × 2 days, then increase to 5 mg/day, target 10 mg/day on day 8 • Child 6-18 yr <50 kg: PO 2 mg/day, increase to 5 mg/day after 2 days; may increase to 10 mg/day; adjust dose ≥1 wk Potential CYP2D6 inhibitor, strong CYP3A4 inhibitors • Adult: PO reduce to 50% of usual dose; increase dose when CYP2D6, CYP3A4 in- hibitors withdrawn Combination of strong CYP3A4/ CYP2D6 inhibitors • Adult: PO reduce to 25% of usual dose
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Available forms: Tablets 2, 5, 10, 15, 20, 30 mg; injection 9.75 mg/1.3 mL; orally disintegrating tablet 10, 15 mg; oral solution 1 mg/mL; suspension for injection 441 mg/1.6 mL, 662 mg/2.4 mL, 882 mg/3.2 mL in prefilled syringes (Aristada); 675 mg/2.4 mL (Arisada Ini- tio); Tablet 2, 5, 10, 15, 20, 30 mg (Abilify MyCite with sensor)
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Administer: PO route • Store in tight, light-resistant container • May be given without regard to meals • Orally disintegrating tablets: do not open blister until ready to use, do not push tablet through foil; place on tongue, allow to dissolve, swallow, do not divide • Oral liquid: use calibrated measuring A device • Oral solution: can be substituted for tablet mg per mg, up to 25-mg dose. Patients receiving 30-mg tablets should receive 25 mg, immediate release of solution IM (extended release) route • Mycite tablets: May give without regard to meals • Swallow tablets whole; do not divide, crush, or chew • The tablets are embedded with an in- gestible event marker (IEM) intended to track drug ingestion with a wearable sen- sor (Mycite patch) and smartphone app • Although most ingestions will be de- tected within 30 min, it may take up to 2 hr for the app and web portal to detect inges- tion of the tablet. If the tablet is not detected after ingestion, do not repeat the dose • It is not recommended to use the tab- lets to track drug ingestion in “real time” or during an emergency because detection may be delayed or not occur • Mycite patch: The patch detects the signal from the IEM sensor embedded in the tablet after ingestion and transmits data to a smartphone • Apply only when instructed by the Mycite app to the left side of the body just above the lower edge of the rib cage • Ensure that the app is paired with the patch before use. The status of the patch is indicated by a status icon in the app to inform the user that the patch is properly adhered and fully functioning • Do not place the patch where the skin is scraped, cracked, inflamed, or irri- tated or in an area that overlaps the most recently removed patch • Do not remove the patch when show- ering, swimming, or exercising • Change the patch weekly or sooner if needed. The app will prompt you to change the patch and will direct you to apply and remove the patch correctly • Remove the patch when having an MRI and replace it with a new one as soon as possible. If there is skin irrita- tion, remove the patch • Give IM only; inject slowly, deeply into muscle mass; discard unused portion; do not give IV or SUBCUT • Available as ready to use • Extended release monthly (Abilify Maintena)
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Assess:
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Evaluate: • Therapeutic response: decrease in emotional excitement, hallucinations, de- lusions, paranoia; reorganization of pat- terns of thought, speech
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That orthostatic hypotension may oc- cur; to rise from sitting or lying position gradually • To avoid hot tubs, hot showers, tub baths; hypotension may occur • To avoid abrupt withdrawal of this product; EPS may result; product should be withdrawn slowly • To avoid OTC preparations (cough, hay fever, cold) unless approved by pre- scriber because serious product interac- tions may occur; to avoid use with alco- hol, CNS depressants because increased drowsiness may occur • To avoid hazardous activities if drowsy, dizzy • About compliance with product regimen • To report impaired vision, tremors, muscle twitching • That examinations and blood work will be needed during treatment • That weight gain may occur, to notify health care professional of large weight gain • That heat stroke may occur in hot weather; to take extra precautions to stay cool
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PHARMACOKINETICS PO: Absorption 87%; extensively metabo- lized by liver to a major active metabolite by CYP3A4/CYP2D6; plasma protein binding >99%; half-life 75 hr; excretion via urine 25%, feces 55%; clearance decreased in geriatric patients
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• Adult: PO 2-5 mg/day as an adjunct to other antidepressant treatment; adjust by 5 mg at ≥1 wk (range, 2-15 mg/day) Schizophrenia (Abilify Maintena PO/IM)
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• Adult: PO 10-15 mg/day; if needed, dosage may be increased to 30 mg/day after 2 wk; maintenance 15 mg/day; peri- odically reassess; IM/extended release (monthly injection suspension) 400 mg monthly
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• Adult: PO 15 mg/day, may increase to 30 mg if needed (monotherapy); adjunc- tive to lithium or valproate PO 10-15 mg daily, may increase to 30 mg if needed
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• Adult: IM 9.75 mg as a single dose, may start with a lower dose, max 30 mg/day Irritability associated with autism
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• Adult: PO reduce to 50% of usual dose; increase dose when CYP2D6, CYP3A4 in- hibitors withdrawn Combination of strong CYP3A4/ CYP2D6 inhibitors
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• Adult: PO reduce to 25% of usual dose
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