AdultPediatricDosage Forms & Strengths tablet 2mg 5mg 10mg 15mg 20mg 30mg tablet, embedded with ingestible event marker (IEM) sensor (Abilify MyCite) 2mg 5mg 10mg 15mg 20mg 30mg Abilify MyCite system is composed of the following components: Aripiprazole tablet embedded with an ingestible event marker (IEM) sensor MyCite patch (wearable sensor) that detects the signal from the IEM sensor after ingestion and transmits data to a smartphone MyCite APP, a smartphone application (app) which is used with a compatible smartphone to display information for the patient Web-based portal for healthcare professionals and caregivers oral disintegrating tablet 10mg 15mg oral solution 1mg/mL extended-release injectable IM suspension (Abilify Maintena) 300mg/vial or prefilled dual chamber syringe 400mg/vial or prefilled dual chamber syringe extended-release injectable IM suspension (aripiprazole lauroxil [Aristada]) 441mg/prefilled syringe (300 mg of aripiprazole) 662mg/prefilled syringe (450 mg of aripiprazole) 882mg/prefilled syringe (600 mg of aripiprazole) 1064mg/prefilled syringe (724 mg of aripiprazole) extended-release injectable IM suspension (aripiprazole lauroxil [Aristada Initio]) 675mg/2.4mL prefilled syringe (459 mg of aripiprazole) Schizophrenia Indicated for treatment of schizophrenia Also see Administration PO 10-15 mg/day PO initially; may increase after 2 weeks at each dose strength; not to exceed 30 mg/day PO when administered as tablet formulation; efficacy not significantly greater above 15 mg/day Abilify Maintena Patients who have never taken aripiprazole 400 mg IM once monthly initially Establish tolerability with aripiprazole PO prior to initiating treatment with Abilify Maintena; may take up to ~ 2 weeks to fully assess tolerability Continue aripiprazole PO (10-20 mg/day) or other antipsychotics PO in patients with known aripiprazole tolerance for 14 consecutive days after initial injection Patients stabilized or aripiprazole tolerant 400 mg IM once monthly 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 Aristada (IM once monthly) Establish tolerability with PO aripiprazole before initiating Aristada; may take up to 2 weeks to fully assess tolerability Base initial Aristada dose on current aripiprazole PO dose; coadminister aripiprazole PO for 21 consecutive days 10 mg/day PO: 441 mg IM once monthly 15 mg/day PO: 662 mg IM once monthly or 882 mg IM q6wk or 1064 mg IM q2mo ≥20 mg/day PO: 882 mg IM once monthly 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 Initio (single IM dose) Indicated in combination with aripiprazole PO for the initiation of Aristada when used for the treatment of schizophrenia Used a single dose to initiate Aristada treatment or as a single dose to re-initiate Aristada treatment following a missed dose of Aristada Establish tolerability with aripiprazole PO prior to initiating treatment with Aristada Initio; may take up to ~ 2 weeks to fully assess tolerability After establishing tolerability with aripiprazole PO, administer the first Aristada IM injection (441 mg, 662 mg, 882 mg, or 1064 mg) in conjunction with both: One dose of Aristada Initio 675 mg IM and one dose of aripiprazole 30 mg PO Aristada Initio is only to be used as a single dose and is not for repeated dosing First Aristada extended-release IM injection may be administered on the same day as Aristada Initio or up to 10 days thereafter (Refer to Aristada for prescribing information) Also see Dosing Considerations Abilify Asimtufii (IM every 2 months) Never taken aripiprazole Establish tolerability with oral aripiprazole before initiating 960 mg IM q2Months May take up to 2 weeks to fully assess tolerability Continue oral aripiprazole (10-20 mg/day) or other antipsychotics PO in patients with known aripiprazole tolerance for 14 consecutive days after initial injection Treated with oral antipsychotics Taking oral aripiprazole: Administer first dose along with oral aripiprazole 10-20 mg PO for 14 consecutive days Stable on another oral antipsychotic (and known to tolerate aripiprazole): Administer first injection along with oral antipsychotic for 14 consecutive days Receiving Abilify Maintena For patients receiving Abilify Maintena (once monthly dosing), administer Abilify Asimtufii 960 mg once q2month in place of next scheduled injection of Abilify Maintena Administer first Abilify Asimtufii injection in place of second, or later injection of Abilify Maintena If there are adverse reactions with Abilify Asimtufii 960-mg dosage, may reduce dosage to 720 mg once q2months May give Abilify Asimtufii up to 2 weeks before or 2 weeks after 2-month scheduled timepoint Bipolar Mania Indicated for maintenance monotherapy treatment of bipolar I disorder in adults PO Indicated for 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 PO initially; may be increased gradually; not to exceed 30 mg/day Adjunct to lithium or valproate: 10-15 mg/day PO 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 >6 weeks not studied Abilify Maintena Patients who have never taken aripiprazole 400 mg IM once monthly initially Administer only by deep IM injection into deltoid or gluteal muscle by healthcare professional Establish tolerability with aripiprazole PO prior to initiating treatment with Abilify Maintena; may take up to ~ 2 weeks to fully assess tolerability Continue aripiprazole PO (10-20 mg/day) or other PO antipsychotics in patients with known aripiprazole tolerance for 14 consecutive days after initial injection Patients stabilized or aripiprazole tolerant 400 mg IM once monthly 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 Abilify Asimtufii (IM every 2 months) Never taken aripiprazole Establish tolerability with oral aripiprazole before initiating 960 mg IM q2Months May take up to 2 weeks to fully assess tolerability Continue oral aripiprazole (10-20 mg/day) or other antipsychotics PO in patients with known aripiprazole tolerance for 14 consecutive days after initial injection Treated with oral antipsychotics Taking oral aripiprazole: Administer first dose along with oral aripiprazole 10-20 mg PO for 14 consecutive days Stable on another oral antipsychotic (and known to tolerate aripiprazole): Administer first injection along with oral antipsychotic for 14 consecutive days Receiving Abilify Maintena For patients receiving Abilify Maintena (once monthly dosing), administer Abilify Asimtufii 960 mg once q2month in place of next scheduled injection of Abilify Maintena Administer first Abilify Asimtufii injection in place of second, or later injection of Abilify Maintena If there are adverse reactions with Abilify Asimtufii 960-mg dosage, may reduce dosage to 720 mg once q2months May give Abilify Asimtufii up to 2 weeks before or 2 weeks after 2-month scheduled timepoint Major Depressive Disorder 2-5 mg/day PO initially; increased weekly PRN by ≤5 mg/day to dose range of 2-15 mg/day Used adjunctively with other antidepressants Dosage Modifications (Oral) Poor metabolizers and drugs that affect cytochrome-P 450 Known CYP2D6 poor metabolizers: Administer half of recommended dose Known CYP2D6 poor metabolizers taking concomitant strong CYP3A4 inhibitors: Administer a quarter of the recommended dose (ie, decrease dose by 75%) Strong CYP2D6 or CYP3A4 inhibitors: Administer half of recommended dose Strong CYP2D6 AND CYP3A4 inhibitors: Administer a quarter of the recommended dose (ie, decrease dose by 75%) Strong CYP3A4 inducers: double recommended dose over 1-2 weeks Dosage Modifications (Abilify Maintena) CYP2D6 poor metabolizers: 300 mg IM CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitor: 200 mg IM Patients taking 400 mg IM Strong CYP2D6 OR CYP3A4 inhibitors: 300 mg IM CYP2D6 AND CYP 3A4 inhibitors: 200 mg IM CYP3A4 inducers: Avoid use Patients taking 300 mg IM Strong CYP2D6 OR CYP3A4 inhibitors: 200 mg IM CYP2D6 AND CYP3A4 inhibitors: 160 mg IM CYP3A4 inducers: Avoid use Dosage Modifications (Aristada) No dosage changes if CYP450 modulators are added for <2 wk Strong CYP3A4 inhibitor for >2 wk 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, 882 mg, or 1064 mg; no dosage adjustment necessary in patients taking 441 mg, if tolerated Strong CYP2D6 inhibitor for >2 wk 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 >2 wk Avoid use for patients taking 662 mg, 882 mg, or 1064 mg No dosage adjustment necessary in patients taking 441 mg, if tolerated CYP3A4 inducers for >2 wk No dose adjustment for 662 mg, 882 mg, or 1064 mg Increase the 441 mg dose to 662 mg Dosage Modifications (Aristada Initio) Only available at a single strength as a single-dose prefilled syringes, so no dosage adjustments are possible CYP2D6 poor metabolizers, strong CYP3A4 inhibitors, and strong CYP3A4 inducers: Avoid use Hepatic impairment Mild-to-severe (Child-Pugh score 5-15): No dosage adjustment necessary Renal impairment Mild-to-severe (GFR 15-90 mL/min): No dosage adjustment necessary Dosage Modifications (Abilify Asimtufii) CYP2D6 poor metabolizers Known CYP2D6 poor metabolizers: 720 mg q2months Known CYP2D6 poor metabolizers taking concomitant CYP3A4 inhibitors: Avoid use Coadministration with strong CYP2D6 inhibitors Patients taking 960 mg: Decrease to 720 mg q2months Coadministration with strong CYP3A4 inhibitors Patients taking 960 mg: Decrease to 720 mg q2months Coadministration with strong CYP2D6 inhibitors and strong CY3A4 inhibitors Patients taking 960 mg: Avoid use Coadministration with strong CY3A4 inducers Patients taking 960 mg: Avoid use Dosing Considerations Aristada Initio Not interchangeable with Aristada due to differing pharmacokinetic profiles Abilify MyCite indications Treatment of adults with schizophrenia Adjunctive treatment of adults with major depressive disorder Treatment of bipolar I disorder Treatment of bipolar I disorder Acute treatment of adults with manic and mixed episodes as monotherapy and as adjunct to lithium or valproate Maintenance treatment of adults as monotherapy and as adjunct to lithium or valproate Abilify MyCite detection Most ingestions will be detected within 30 minutes, although it may take up to 2 hr for the smartphone app and web portal to detect the ingested tablet In some cases, the ingested tablet may not be detected If the tablet is not detected after ingestion, do not repeat the dose N-Glycanase 1 Deficiency (Orphan) Orphan designation for treatment of N-glycanase 1 (NGLY1) deficiency Orphan sponsor Perlara PBC; 2625 Alcatraz Ave, #435; Berkeley, California 94705 Dosage Forms & Strengths tablet 2mg 5mg 10mg 15mg 20mg 30mg tablet, orally disintegrating 10mg 15mg oral solution 1mg/mL Schizophrenia Indicated for treatment of schizophrenia in adolescents aged13-17 years <13 years: Safety and efficacy not established 13-17 years: 2 mg/day PO initially; increase to 5 mg/day after 2 days; may further increase to recommended dose of 10 mg/day after additional 2 days; subsequent doses may increase by 5 mg/day; maintenance: 10-30 mg/day Bipolar Mania Indicated for acute manic or mixed episodes, either as monotherapy or as adjunct to lithium or valproate 10-17 years: 2 mg/day PO initially; increased to 5 mg/day after 2 days; may further increase to recommended dosage of 10 mg/day after additional 2 days; subsequent doses may increase by 5 mg/day; maintenance: 10-30 mg/day Autism Indicated for irritability associated with autistic disorder <6 years: Safety and efficacy not established 6-17 years: 2 mg/day PO initially; increase gradually at ≥1 week intervals to target dosage of 5 mg/day; may gradually be further increase PRN to 10 mg/day or higher; not to exceed 15 mg/day Tourette Disorder Indicated for treatment of Tourette disorder <6 years: Safety and efficacy not established 6-18 years (<50 kg) Initiate at 2 mg/day PO 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 6-18 years (≥50 kg) Initiate at 2 mg/day PO 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) Poor metabolizers and drugs that affect cytochrome-P 450 Known CYP2D6 poor metabolizers: Administer half of recommended dose Known CYP2D6 poor metabolizers taking concomitant strong CYP3A4 inhibitors: Administer a quarter