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Antipsychotics Therapeutic Class Review (TCR) Antipsychotics Therapeutic Class Review (TCR) June 9, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. June 2020 Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004 – 2020 Magellan Rx Management. All Rights Reserved. FDA-APPROVED INDICATIONS Indications are for adults unless additional ages are specified. Psychotic Bipolar Disorder Drug Manufacturer Other Indications Schizophrenia Disorders (acute manic episodes) First-Generation Antipsychotics – Oral amitriptyline/ Mylan Moderate to severe anxiety and/or agitation and depressed -- -- -- perphenazine1 mood; depressed patients in whom anxiety and/or agitation are severe; depression and anxiety in association with chronic physical disease chlorpromazine2 generic Acute intermittent porphyria; intractable hiccups; presurgical X X X apprehension and/or restlessness (ages ≥ 6 months); N/V (ages ≥ 6 months); tetanus (adjunct); severe behavioral problems in children (ages 1 to 12 years); short-term treatment of hyperactive children with accompanying conduct disorder (ages 1 to 12 years) fluphenazine3 generic -- -- X -- haloperidol4 generic Severe behavior problems in children with combative, -- X -- explosive hyperexcitability following prior therapy failure (ages (ages ≥ 3 years) 3 to 12 years); short-term treatment of hyperactive children with accompanying conduct disorder following prior therapy failure (ages 3 to 12 years); tics and vocal utterances associated with Tourette’s disorder (ages ≥ 3 years) loxapine5 generic -- X -- -- molindone6 Epic -- X -- -- (ages ≥ 12 years) perphenazine7 generic N/V X -- -- (ages ≥ 12 years) (ages ≥ 12 years) pimozide8 Par Motor and phonic tics associated with Tourette’s disorder -- -- -- (second-line; ages ≥ 2 years) N/V = nausea/vomiting† Antipsychotics Review – June 2020 Page 2 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Other Indications Schizophrenia Psychotic Bipolar Disorder Disorders (acute manic episodes) First-Generation Antipsychotics – Oral (continued) thioridazine9,10 generic -- X -- -- (second-line; pediatrics*) thiothixene11 generic -- X -- -- (ages ≥ 12 years) trifluoperazine12 generic Non-psychotic anxiety (second-line; up to 12 weeks) X -- -- (ages ≥ 6 years) First-Generation Antipsychotics – Inhaled loxapine Galen Acute agitation associated with bipolar I X -- -- inhalation (acute agitation powder associated with (Adasuve®)13 schizophrenia) First-Generation Antipsychotics – Short Acting Injectable chlorpromazine generic Acute intermittent porphyria; intractable hiccups; presurgical X -- X hydrochloride14 apprehension (ages ≥ 6 months); N/V (ages ≥ 6 months); (mania) tetanus (adjunct; ages ≥ 6 months); short-term treatment of hyperactivity in children with conduct disorder (ages 1 to 12 years); severe behavioral problems in children (ages 1 to 12 years) fluphenazine generic -- -- X -- hydrochloride15 haloperidol generic, Janssen Tics and vocal utterances of Tourette’s disorder X -- -- lactate (Haldol®)16 N/V = nausea/vomiting * Pediatric age limit is not specified in thioridazine prescribing information. Antipsychotics Review – June 2020 Page 3 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Drug Manufacturer Other Indications Schizophrenia Psychotic Bipolar Disorder Disorders (acute manic episodes) First-Generation Antipsychotics – Long Acting Injectable fluphenazine generic -- X -- -- decanoate17 haloperidol generic, Janssen -- X -- -- decanoate (Haldol® Decanoate)18 N/V = nausea/vomiting Bipolar Disorder Drug Manufacturer Other Indications Schizophrenia Acute Manic Depressive Acute Mixed Maintenance Episodes Episodes Episodes Second-Generation Antipsychotics – Oral aripiprazole generic, Otsuka Major depressive X X -- X X (Abilify®)19 disorder (adjunct); (ages ≥ 13 years) (ages ≥ 10 years for (ages ≥ 10 years (monotherapy Irritability associated acute treatment as for acute and in with autistic disorder monotherapy and in treatment as combination (ages 6 to 17 years); combination with monotherapy and with lithium or Tourette’s disorder lithium or valproate) in combination valproate for (ages 6 to 18 years) with lithium or ages ≥ 10 years) valproate) aripiprazole Otsuka Major depressive X X -- X X (with sensor)† disorder (adjunct) (acute treatment as (acute treatment (monotherapy (Abilify monotherapy and in as monotherapy and in Mycite®)20 combination with and in combination lithium or valproate) combination with with lithium or lithium or valproate) valproate) † Abilify Mycite is a drug-device combination product of aripiprazole tablets embedded with an ingestible event marker (IEM) sensor intended to track drug ingestion approved for use in adults only. Limitations of use include that its ability to improve patient compliance or modify dosage has not been established and that it should not be used in “real-time” or emergency situations to track ingestion as detection may not occur or may be delayed. Antipsychotics Review – June 2020 Page 4 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Bipolar Disorder Drug Manufacturer Other Indications Schizophrenia Acute Manic Depressive Acute Mixed Maintenance Episodes Episodes Episodes Second-Generation Antipsychotics – Oral (continued) asenapine Forest/Allergan -- X X -- X X (Saphris®)21 (ages ≥ 10 years for (ages ≥ 10 years (monotherapy; acute treatment as for acute adults only) monotherapy; adults treatment as in combination with monotherapy; lithium or valproate) adults in combination with lithium or valproate) asenapine‡ Noven -- X -- -- -- -- (Secuado®)22 brexpiprazole Otsuka Major depressive X -- -- -- -- (Rexulti®)23 disorder (adjunct) cariprazine Allergan -- X X X X -- (Vraylar®)24 (acute treatment) (acute treatment) clozapine generic, -- X -- -- -- -- 25 (Clozaril®) Novartis/HLS (treatment-resistant clozapine generic, Jazz schizophrenia; reducing (Fazaclo®)26 suicidal behavior in schizophrenia or clozapine Trupharma schizoaffective disorder (Versacloz®)27 iloperidone§ Vanda -- X -- -- -- -- (Fanapt®)28 lumateperone Intra-cellular -- X -- -- -- -- (Caplyta®)29 ‡ Approved as a New Drug Application (NDA) via the 505(b)(2) pathway, which is a Food and Drug Administration (FDA) approval pathway in which at least some of the information required for approval comes from studies not conducted by or for the applicant. § When choosing treatments for schizophrenia, prescribers should consider the ability of iloperidone (Fanapt) to prolong the QT interval and the use of other agents first. Originally, this product was marketed by Novartis via an agreement with Vanda; however, that was discontinued and Vanda is now marketing the product. Antipsychotics Review – June 2020 Page 5 | Proprietary Information. Restricted Access – Do not disseminate or copy without approval. © 2004-2020 Magellan Rx Management. All Rights Reserved. FDA-Approved Indications (continued) Bipolar Disorder Drug Manufacturer Other Indications Schizophrenia Acute Manic Depressive Acute Mixed Maintenance Episodes Episodes Episodes Second-Generation Antipsychotics – Oral (continued) lurasidone Sunovion -- X -- X -- -- (Latuda®)30 (ages ≥ 13 years) (ages ≥ 10 years as monotherapy and in adults in combination with lithium or valproate) olanzapine generic, Eli Lilly Treatment-resistant X X X X X (Zyprexa®)31 depression (in (ages ≥ 13 years; (ages ≥ 13 years as (ages ≥ 10 years; in (ages ≥ 13 years as (ages ≥ 13 years) combination with second-line in monotherapy and in combination with monotherapy and in fluoxetine) adolescents due to combination with fluoxetine) combination with metabolic effects) lithium or valproate; lithium or valproate; second-line in second-line in adolescents due to adolescents due to metabolic effects) metabolic
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