aripiprazole

Therapeutic Classification: antipsychotics, mood stabilizers

Pharmacologic Classification: serotonin-dopamine activity modulators (SDAM)

BEERS REMS

Abilify, Abilify Asimtufii, Abilify Maintena, Aristada, and Opipza

Schizophrenia.

Abilify

Treatment of the following conditions:
- Acute treatment of manic and mixed episodes associated with bipolar I disorder (as monotherapy or with lithium or valproate).
- Agitation associated with schizophrenia or bipolar disorder.

Abilify Asimtufii and Abilify Maintena

Maintenance treatment of bipolar I disorder (as monotherapy).

Abilify and Opipza

Treatment of the following conditions:
- Adjunctive treatment of depression.
- Irritability associated with autistic disorder.
- Tourette disorder.

Psychotropic activity may be due to agonist activity at dopamine D₂ and serotonin 5-HT_1A receptors and antagonist activity at the 5-HT_2A receptor.
Also has alpha₁-adrenergic blocking activity.

Therapeutic effects:

Decreased manifestations of schizophrenia.
Decreased mania in bipolar patients.
Decreased symptoms of depression.
Decreased agitation associated with schizophrenia or bipolar disorder.
Decreased emotional and behavioral symptoms of irritability.
Decreased incidence of tics.

Absorption: Well absorbed (87%) following oral administration; 100% following IM injection.

Distribution: Extensively distributed to tissues.

Protein Binding: >99%.

Metabolism/Excretion: Mostly metabolized by the liver by the CYP3A4 and CYP2D6 isoenzymes; the CYP2D6 enzyme system exhibits genetic polymorphism; ∼7% of population may be poor metabolizers (PMs) and may have significantly ↑ aripiprazole concentrations and an ↑ risk of adverse effects (↓ dose by 50% in PMs); one metabolite (dehydro-aripiprazole) has antipsychotic activity. 18% excreted unchanged in feces; <1% excreted unchanged in urine.

Half-Life: Aripiprazole: 75 hr; dehydro-aripiprazole: 94 hr; ER injectable suspension: 30–46 days (Abilify Maintena); 29–35 days (Aristada).

(antipsychotic effect)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	2 wk	unknown
ER-IM	unknown	unknown	unknown

Contraindicated in:

Hypersensitivity;
CYP2D6 PMs or concurrent use of strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers (Aristada Initio only).

Use Cautiously in:

May ↑ risk of suicide attempt/ideation, especially during early treatment or dose adjustment; this risk appears to be greater in adolescents or children
;
Known cardiovascular or cerebrovascular disease;
CYP2D6 PMs (↓ dose);
Conditions that cause hypotension (dehydration, treatment with antihypertensives or diuretics);
Diabetes (may ↑ risk of hyperglycemia);
Seizure disorders;
Patients at risk for aspiration pneumonia or falls;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk; neonates at ↑ risk for extrapyramidal symptoms and withdrawal after delivery when exposed during the 3rd trimester;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri:
Appears on Beers list. ↑ risk of stroke, cognitive decline, and mortality in older adults with dementia. Avoid use in older adults, except for schizophrenia, bipolar disorder, or adjunctive treatment of major depressive disorder
.

CV: bradycardia, chest pain, edema, hypertension, orthostatic hypotension, tachycardia

Derm: DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), dry skin, ecchymosis, skin ulcer, sweating

EENT: blurred vision, conjunctivitis, ear pain

Endo: ↓prolactin, hyperglycemia

GI: constipation, ↑salivation, anorexia, nausea, vomiting, weight loss

GU: urinary incontinence

Hemat: AGRANULOCYTOSIS, anemia, leukopenia, neutropenia

Local: injection site reactions

Metab: dyslipidemia, weight gain

MS: muscle cramps, neck pain

Neuro: drowsiness, extrapyramidal reactions, tremor, abnormal gait, akathisia, confusion, depression, fatigue, hostility, impaired cognitive function, impaired motor function, impulse control disorders (eating/binge eating, gambling, sexual, shopping), insomnia, light-headedness, manic reactions, nervousness, restlessness, sedation, SEIZURES, SUICIDAL THOUGHTS, tardive dyskinesia

Resp: dyspnea

Misc: ↓heat regulation, HYPERSENSITIVITY REACTIONS, NEUROLEPTIC MALIGNANT SYNDROME

Drug-drug:

Strong CYP3A4 inhibitors, including ketoconazole and clarithromycin, may ↑ levels and risk of toxicity; ↓ aripiprazole dose by 50%.
Strong CYP2D6 inhibitors, including quinidine, fluoxetine, or paroxetine, may ↑ levels and risk of toxicity; ↓ aripiprazole dose by ≥50%.
CYP3A4 inducers may ↓ levels and effectiveness; double aripiprazole dose.

If used concurrently with combination of strong, moderate, or weak CYP3A4 and CYP2D6 inhibitors, ↓ oral aripiprazole dose by 75%. Aripiprazole dose should be ↓ by 75% in CYP2D6 PMs who are concurrently receiving a strong CYP3A4 inhibitor. Do NOT substitute Aristada Initio for Aristada.

Schizophrenia

PO (Adults ): 10 or 15 mg once daily; doses up to 30 mg/day have been used; increments in dosing should not be made before 2 wk at a given dose. CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.
PO (Children 13–17 yr): 2 mg once daily; ↑ to 5 mg once daily after 2 days, and then to target dose of 10 mg once daily after another 2 days; may further ↑ dose in 5-mg increments if needed (max: 30 mg/day). CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.
Abilify Maintena (1-day initiation)
IM (Adults ): Administer two injections of 400 mg (total of 800 mg) in two different injection sites and one dose of oral aripiprazole 20 mg on the 1st day of treatment with Abilify Maintena; then continue with 400 mg once monthly. If no adverse reactions to 400 mg once monthly dose, may ↓ dose to 300 mg once monthly. CYP2D6 PMs: Administer two injections of 300 mg (total of 600 mg) in two different injection sites and one dose of oral aripiprazole 20 mg on the 1st day of treatment with Abilify Maintena; then continue with 300 mg once monthly. CYP2D6 PMs concurrently using CYP3A4 inhibitor: Avoid use; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor: Administer two injections of 300 mg (total of 600 mg) in two different injection sites and one dose of oral aripiprazole 20 mg on the 1st day of treatment with Abilify Maintena; then continue with 300 mg once monthly. Concurrent use of CYP2D6 and CYP3A4 inhibitor: Avoid use; Concurrent use of CYP3A4 inducer: Avoid use.
Abilify Maintena (14-day initiation)
IM (Adults ): 400 mg once monthly; after 1st injection, if previously receiving oral aripiprazole, continue treatment with oral aripiprazole (10–20 mg/day) for 14 days. If previously stable on another oral antipsychotic (but known to tolerate aripiprazole), after 1st injection, continue treatment with oral antipsychotic for 14 days. If no adverse reactions to 400 mg once monthly dose, may ↓ dose to 300 mg once monthly. CYP2D6 PMs:↓ dose to 300 mg once monthly; CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose to 200 mg once monthly; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose to 300 mg once monthly (if originally receiving 400 mg once monthly) or 200 mg once monthly (if originally receiving 300 mg once monthly); Concurrent use of CYP2D6 and CYP3A4 inhibitor:↓ dose to 200 mg once monthly (if originally receiving 400 mg once monthly) or 160 mg once monthly (if originally receiving 300 mg once monthly); Concurrent use of CYP3A4 inducer: Avoid use.
Abilify Asimtufii (1-day initiation)
IM (Adults ): Receiving oral antipsychotics: Administer one injection of Abilify Asimtufii 960 mg in the gluteal muscle, one injection of Abilify Maintena 400 mg in a separate gluteal or deltoid muscle, and one dose of oral aripiprazole 20 mg on the first day of treatment with Abilify Asimtufii; then continue with Abilify Asimtufii 960 mg every 2 mo. CYP2D6 PMs:Administer one injection of Abilify Asimtufii 720 mg in the gluteal muscle, one injection of Abilify Maintena 300 mg in a separate gluteal or deltoid muscle, and one dose of oral aripiprazole 20 mg on the first day of treatment with Abilify Asimtufii; then continue with Abilify Asimtufii 720 mg every 2 mo; CYP2D6 PMs concurrently using CYP3A4 inhibitor: Avoid use; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor: Administer one injection of Abilify Asimtufii 720 mg in the gluteal muscle, one injection of Abilify Maintena 300 mg in a separate gluteal or deltoid muscle, and one dose of oral aripiprazole 20 mg on the first day of treatment with Abilify Asimtufii; then continue with Abilify Asimtufii 720 mg every 2 mo; Concurrent use of strong CYP2D6 and strong CYP3A4 inhibitor: Avoid use; Concurrent use of CYP3A4 inducer: Avoid use.
Abilify Asimtufii (14-day initiation)
IM (Adults ): Receiving oral antipsychotics: 960 mg every 2 mo (56 days after previous injection); after 1st injection, if previously receiving oral aripiprazole, continue treatment with oral aripiprazole (10–20 mg/day) for 14 days. If previously stable on another oral antipsychotic (but known to tolerate aripiprazole), after 1st injection, continue treatment with oral antipsychotic for 14 days. Previously receiving Abilify Maintena: 960 mg every 2 mo in place of the next scheduled Abilify Maintena injection; the 1st injection may be administered in place of the 2nd or later injection of Abilify Maintena; CYP2D6 PMs:↓ dose to 720 mg every 2 mo; CYP2D6 PMs concurrently using CYP3A4 inhibitor: Avoid use; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose to 720 mg every 2 mo; Concurrent use of strong CYP2D6 and strong CYP3A4 inhibitor: Avoid use; Concurrent use of CYP3A4 inducer: Avoid use.
Aristada
IM (Adults ): With Aristada Initio: Administer 675-mg injection of Aristada Initio with first injection of Aristada (dose is based on total daily dose of oral aripiprazole; if patient receiving 10 mg/day of oral aripiprazole, administer 441 mg once monthly; if patient receiving 15 mg/day of oral aripiprazole, administer 662 mg once monthly, 882 mg every 6 wk, or 1064 mg every 2 mo; if patient receiving ≥20 mg/day of oral aripiprazole, administer 882 mg once monthly) (initial Aristada dose can be given on same day as or within 10 days of Aristada Initio) AND one dose of oral aripiprazole 30 mg; Without Aristada Initio: Dose is based on total daily dose of oral aripiprazole; if patient receiving 10 mg/day of oral aripiprazole, administer 441 mg once monthly; if patient receiving 15 mg/day of oral aripiprazole, administer 662 mg once monthly, 882 mg every 6 wk, or 1064 mg every 2 mo; if patient receiving ≥20 mg/day of oral aripiprazole, administer 882 mg once monthly; after 1st injection; continue treatment with oral aripiprazole for 21 days; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor for >2 wk:↓ dose of Aristada to 441 mg once monthly (if originally receiving 662 mg once monthly) or 662 mg once monthly (if originally receiving 882 mg once monthly); no dose adjustment necessary if originally receiving 441 mg once monthly; avoid use of Aristada Initio; CYP2D6 PMs concurrently using strong CYP3A4 inhibitor for >2 wk:↓ dose of Aristada to 441 mg once monthly (if originally receiving 662 mg or 882 mg once monthly); no dose adjustment necessary if originally receiving 441 mg once monthly; avoid use of Aristada Initio; Concurrent use of strong CYP2D6 and CYP3A4 inhibitor: Avoid use of Aristada in patients requiring 662 mg or 882 mg once monthly dose; no dose adjustment of Aristada necessary if originally receiving 441 mg once monthly; avoid use of Aristada Initio; Concurrent use of CYP3A4 inducer:↑ dose of Aristada to 662 mg once monthly (if originally receiving 441 mg once monthly); no dose adjustment if Aristada necessary if originally receiving 662 mg or 882 mg once monthly; avoid use of Aristada Initio.

Acute Manic or Mixed Episodes Associated With Bipolar I Disorder

PO (Adults ): 15 mg once daily as monotherapy or 10–15 mg once daily with lithium or valproate; target dose is 15 mg once daily; may ↑ to 30 mg once daily, if needed. CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.
PO (Children 10–17 yr): 2 mg once daily; ↑ to 5 mg once daily after 2 days, and then to target dose of 10 mg once daily after another 2 days; may further ↑ dose in 5-mg increments if needed (max: 30 mg/day). CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.

Maintenance Treatment of Bipolar I Disorder

Abilify Maintena (1-day initiation)
IM (Adults ): Administer two injections of 400 mg (total of 800 mg) in two different injection sites and one dose of oral aripiprazole 20 mg on the 1st day of treatment with Abilify Maintena; then continue with 400 mg once monthly. If no adverse reactions to 400 mg once monthly dose, may ↓ dose to 300 mg once monthly. CYP2D6 PMs: Administer two injections of 300 mg (total of 600 mg) in two different injection sites and one dose of oral aripiprazole 20 mg on the 1st day of treatment with Abilify Maintena; then continue with 300 mg once monthly. CYP2D6 PMs concurrently using CYP3A4 inhibitor: Avoid use; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor: Administer two injections of 300 mg (total of 600 mg) in two different injection sites and one dose of oral aripiprazole 20 mg on the 1st day of treatment with Abilify Maintena; then continue with 300 mg once monthly. Concurrent use of CYP2D6 and CYP3A4 inhibitor: Avoid use; Concurrent use of CYP3A4 inducer: Avoid use.
Abilify Maintena (14-day initiation)
IM (Adults ): 400 mg once monthly; after 1st injection, if previously receiving oral aripiprazole, continue treatment with oral aripiprazole (10–20 mg/day) for 14 days. If previously stable on another oral antipsychotic (but known to tolerate aripiprazole), after 1st injection, continue treatment with oral antipsychotic for 14 days. If no adverse reactions to 400 mg once monthly dose, may ↓ dose to 300 mg once monthly. CYP2D6 PMs:↓ dose to 300 mg once monthly; CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose to 200 mg once monthly; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose to 300 mg once monthly (if originally receiving 400 mg once monthly) or 200 mg once monthly (if originally receiving 300 mg once monthly); Concurrent use of CYP2D6 and CYP3A4 inhibitor:↓ dose to 200 mg once monthly (if originally receiving 400 mg once monthly) or 160 mg once monthly (if originally receiving 300 mg once monthly); Concurrent use of CYP3A4 inducer: Avoid use.
Abilify Asimtufii
IM (Adults ): Receiving oral antipsychotics: 960 mg every 2 mo (56 days after previous injection); after 1st injection, if previously receiving oral aripiprazole, continue treatment with oral aripiprazole (10–20 mg/day) for 14 days. If previously stable on another oral antipsychotic (but known to tolerate aripiprazole), after 1st injection, continue treatment with oral antipsychotic for 14 days. Previously receiving Abilify Maintena: 960 mg every 2 mo in place of the next scheduled Abilify Maintena injection; the 1st injection may be administered in place of the 2nd or later injection of Abilify Maintena; CYP2D6 PMs:↓ dose to 720 mg every 2 mo; CYP2D6 PMs concurrently using strong CYP3A4 inhibitor: Avoid use; Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose to 720 mg every 2 mo; Concurrent use of strong CYP2D6 and CYP3A4 inhibitor: Avoid use; Concurrent use of CYP3A4 inducer: Avoid use.

Depression

PO (Adults ): 2–5 mg once daily; may titrate upward at 1-wk intervals to 5–10 mg once daily (max: 15 mg/day). CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.

Irritability Associated with Autistic Disorder

PO (Children 6–17 yr): 2 mg once daily; ↑ to 5 mg once daily after at least 1 wk; may further ↑ dose in 5-mg increments if needed at ≥1-wk intervals (max: 15 mg/day). CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.

Tourette Disorder

PO (Children 6–18 yr and ≥50 kg): 2 mg once daily; ↑ to target dose of 5 mg once daily after 2 days; may further ↑ dose if needed at ≥1-wk intervals (max: 10 mg/day). CYP2D6 PMs:↓ dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.
PO (Children 6–18 yr and <50 kg): 2 mg once daily; ↑ to 5 mg once daily after 2 days, and then to target dose of 10 mg once daily after 5 days; may further ↑ dose in 5-mg increments if needed at ≥1-wk intervals (max: 20 mg/day). CYP2D6 PMs: ↓dose by 50%. CYP2D6 PMs concurrently using CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP2D6 or CYP3A4 inhibitor:↓ dose by 50%. Concurrent use of strong CYP2D6 and CYP3A4 inhibitor:↓ dose by 75%. Concurrent use of strong CYP3A4 inducer: Double usual dose over 1–2 wk.

(Generic available)

Immediate-release tablets: 2 mg; 5 mg; 10 mg; 15 mg; 20 mg; 30 mg
Orally disintegrating tablets vanilla flavor: 10 mg; 15 mg
Oral film (Opipza): 2 mg; 5 mg; 10 mg
Oral solution orange cream: 1 mg/mL
Extended-release suspension for injection (Abilify Maintena) (prefilled syringes or vials): 300 mg; 400 mg
Extended-release suspension for injection (Aristada) (prefilled syringes): 441 mg/1.6 mL; 662 mg/2.4 mL; 882 mg/3.2 mL; 1064 mg/3.9 mL
Extended-release suspension for injection (Aristada Initio) (prefilled syringes): 675 mg/2.4 mL
Extended-release suspension for injection (Abilify Asimtufii) (prefilled syringes): 720 mg/2.4 mL; 960 mg/3.2 mL

Assess mental status (orientation, mood, behavior) before and periodically during therapy.
Assess for suicidal tendencies, especially during early therapy. Restrict amount of drug available to patient. Risk may be ↑ in adults ≤24 yr. After starting therapy, young adults should be seen by health care provider at least weekly for 4 wk, every 3 wk for next 4 wk, and on advice of health care provider thereafter.
Assess weight and body mass index initially and during therapy. Compare weight of children and adolescents with that expected during normal growth.
Monitor BP (sitting, standing, lying), HR, and respiratory rate before and periodically during therapy.
Observe patient carefully when administering medication to ensure that medication is actually taken and not hoarded or cheeked.
Monitor patient for onset of akathisia (restlessness or desire to keep moving) and extrapyramidal side effects (parkinsonian: difficulty speaking or swallowing, loss of balance control, pill rolling of hands, masklike face, shuffling gait, rigidity, tremors; and dystonic: muscle spasms, twisting motions, twitching, inability to move eyes, weakness of arms or legs) periodically during therapy. Report these symptoms.
Monitor for tardive dyskinesia (uncontrolled rhythmic movement of mouth, face, and extremities; lip smacking or puckering; puffing of cheeks; uncontrolled chewing; rapid or worm-like movements of tongue). Notify health care provider immediately if these symptoms occur, as these side effects may be irreversible.
Monitor for development of neuroleptic malignant syndrome (fever, muscle rigidity, altered mental status, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, loss of bladder control). Notify health care provider immediately if these symptoms occur.
Assess for falls risk. Drowsiness, orthostatic hypotension, and motor and sensory instability ↑ risk. Institute prevention as indicated.
Assess for injection site reactions (pain at site, redness, irritation).

Lab Test Considerations:

May ↑ CK.
- Monitor CBC frequently during initial months of therapy in patients with pre-existing or history of low WBC. May cause leukopenia, neutropenia, or agranulocytosis. Discontinue therapy if this occurs.
- Monitor blood glucose and cholesterol levels before starting and periodically during therapy. Patients with diabetes or risk factors for diabetes mellitus (obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at beginning and periodically during therapy.

Do not confuse aripiprazole with rabeprazole or proton pump inhibitors.
Aristada Initio is only used as a one-time dose to initiate Aristada therapy or if doses of Aristada are missed. Administer missed doses as soon as possible; may supplement next Aristada injection with Aristada Initio. If last Aristada injection 441 mg and time since last injection ≤6 wk, do not supplement; if >6 wk but ≤7 wk since last dose, supplement with single dose of Aristada Initio; if >7 wk since last dose, reinitiate with a single dose of Aristada Initio and a single dose of oral aripiprazole 30 mg. If last Aristada injection 662 mg or 882 mg and time since last injection ≤8 wk, do not supplement; if >8 wk but ≤12 wk since last dose, supplement with single dose of Aristada Initio; if ≥12 wk since last dose, reinitiate with a single dose of Aristada Initio and a single dose of oral aripiprazole 30 mg. If last Aristada injection 1064 mg and time since last injection ≤10 wk, do not supplement; if >8 wk but ≤12 wk since last dose, supplement with single dose of Aristada Initio; if ≥12 wk since last dose, reinitiate with a single dose of Aristada Initio and a single dose of oral aripiprazole 30 mg.
PO: Administer once daily without regard to meals.
- Orally disintegrating tablets: Do not open blister until ready to administer. For single tablet removal, open package and peel back foil on blister to expose tablet. Do not push tablet through foil; may damage tablet. Immediately upon opening blister, using dry hands, remove tablet and place entire oral disintegrating tablet on tongue. Tablet disintegration occurs rapidly in saliva. Take tablet without liquid, but if needed, it can be taken with liquid. Do not attempt to split tablet.
Extended-Release IM: Abilify Maintena is available in vials or dual chamber prefilled syringes. For vials, reconstitute 300-mg vial with 1.5 mL and 400-mg vial with 1.9 mL of sterile water for injection; discard extra sterile water. Withdraw air to equalize pressure in vial. Shake vial vigorously for 30 sec until suspension is uniform; suspension is opaque and milky white. If injection is not given immediately, shake vial vigorously to resuspend prior to injection. Do not store suspension in syringe. Determine volume needed for dose: from 400-mg vial: 400 mg = 2 mL, 300 mg = 1.5 mL, 200 mg = 1.0, and 160 mg = 0.8 mL. From 300-mg vial: 300 mg = 1.5 mL, 200 mg = 1 mL, and 160 mg = 0.8 mL. For prefilled syringes, push plunger rod slightly to engage threads. Rotate plunger rod until rod stops rotating to release diluent; middle stopper will be at indicator line. Vertically shake syringe vigorously for 20 sec until drug is uniformly milky-white. For deltoid site, use 23-gauge needle, 1 inch in length, for nonobese patients and 22-gauge, 1½ inches, for obese patients. For gluteal site, use 22-gauge needle, 1½ inches in length, for nonobese patients and 22-gauge, 2 inches, for obese patients. Inject deep into deltoid or gluteal site; do not massage. Continue oral dosing of aripiprazole for 2 wk after 1st dose of Abilify Maintena . Abilify Maintena should be administered no sooner than 26 days after the previous injection.
- If 2nd or 3rd doses of Abilify Maintena are missed and >4 wk but <5 wk since last injection, administer injection as soon as possible. Resume monthly injections no sooner than 26 days later. If >5 wk since last injection, reinitiate treatment with single or double injection start. If 4th or subsequent doses are missed and >4 wk but <6 wk since last injection, administer injection as soon as possible. Resume monthly injections no sooner than 26 days later. If >6 wk since last injection, reinitiate treatment with single or double injection start.
- Aristada comes in a kit with several needle sizes. Tap syringe ≥10 times to dislodge settled material, and shake syringe vigorously for ≥30 sec to ensure suspension is uniform. Shake again if syringe not used within 15 min. Select needle and injection site. Deltoid may be used for 441 mg dose only. May use gluteal site for all doses. Remove air from syringe. Inject entire contents rapidly and continuously over <10 sec.
- Abilify Asimtufii must be administered as an IM gluteal injection by a health care provider. Do not administer by any other route. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with Abilify Asimtufii. Due to the half-life of oral aripiprazole, it may take up to 2 wk to fully assess tolerability. The suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in color. Do not use Abilify Asimtufii prefilled syringe if the suspension is discolored or contains particulate matter. Tap syringe on your hand ≥10 times. After tapping, shake syringe vigorously for ≥10 sec until medication is uniform. For nonobese patients use a 22-gauge, 1½-inch needle; for obese patients use a 21-gauge, 2-inch needle. Slowly inject the entire contents of prefilled syringe IM into gluteal muscle of patient; do not massage injection site. Abilify Asimtufii should be administered no sooner than 56 days after previous injection.
- If dose of Abilify Asimtufiiis missed >8 wk but <14 wk since last injection, administer dose as soon as possible. Resume regular maintenance injections no sooner than 2 mo later. If >14 wk since last injection, reinitiate treatment with single or double injection start.
Opipza: Administer orally with or without food. Apply on top of the tongue to dissolve in saliva. Can be swallowed without liquid. Administer only one film at a time. If additional film is needed, administer after the previous film has completely dissolved. Refrain from chewing or swallowing undissolved film. Do not cut or split film.

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Advise patient to take medication as directed and not to skip doses or double up on missed doses. Explain what the following steps would be if an injection dose is missed.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking any new medications. Caution patient to avoid taking alcohol or other CNS depressants concurrently with this medication.
Inform patient of possibility of extrapyramidal symptoms and tardive dyskinesia. Instruct patient to report these symptoms immediately.
Advise patient to make position changes slowly to minimize orthostatic hypotension.
Medication may cause drowsiness and light-headedness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care provider immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior occur
.
Inform patient that aripiprazole may cause weight gain. Advise patient to monitor weight periodically. Notify health care provider of significant weight gain.
Advise patient that extremes in temperature should be avoided, because this drug impairs body temperature regulation.
Advise patient to notify health care provider if new or ↑ eating/binge eating, gambling, sexual, shopping, or other impulse control disorders occur.
Advise patient to notify health care provider of medication regimen prior to treatment or surgery.
Emphasize the importance of routine follow-up exams and continued participation in psychotherapy as indicated.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder) have been reported in neonates who were exposed to antipsychotic drugs during the 3rd trimester of pregnancy. Monitor neonates closely. Encourage pregnant patients to enroll in pregnancy exposure registry by contacting National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Decreased manifestations of schizophrenia.
Decreased mania in bipolar patients.
Decreased symptoms of depression.
Decreased agitation associated with schizophrenia or bipolar disorder.
Decreased emotional and behavioral symptoms of irritability.
Decreased incidence of tics.

Abilify, Abilify Asimtufii, Abilify Maintena, Aristada, Aristada Initio, Opipza

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

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