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HIGHLIGHTS OF PRESCRIBING INFORMATION - Eli Lilly and …

1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to use zyprexa safely and effectively. See full PRESCRIBING INFORMATION for (olanzapine) Tablet for Oral useZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral useZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular useInitial Approval: 1996 WARNING: INCREASED MORTALITYIN ELDERLY PATIENTSWITH DEMENTIA-RELATED PSYCHOSISSee full PRESCRIBING INFORMATION for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

constipation, speech disorder, increased salivation, amnesia, paresthesia.(6.1) ZYPREXA and Fluoxetine in Combination:Also refer to the Adverse Reactions section of the package insert for Symbyax.(6) ZYPREXA IntraMuscular for Injection: • Agitation with Schizophrenia and BipolarI Mania(Adults)– somnolence.(6.1)

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Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION - Eli Lilly and …

1 1 HIGHLIGHTS OF PRESCRIBING INFORMATIONT hese HIGHLIGHTS do not include all the INFORMATION needed to use zyprexa safely and effectively. See full PRESCRIBING INFORMATION for (olanzapine) Tablet for Oral useZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral useZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular useInitial Approval: 1996 WARNING: INCREASED MORTALITYIN ELDERLY PATIENTSWITH DEMENTIA-RELATED PSYCHOSISSee full PRESCRIBING INFORMATION for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

2 zyprexa is not approvedfor the treatment of patients with dementia-related psychosis. ( , , 17)When using ZYPREXAand fluoxetine in combination, also refer to the Boxed Warning section of the package insert for MAJOR CHANGES--------------------------Warning s and Precautions, Tardive Dyskinesia( )10/2019 Warnings and Precautions, Use in Patientswith Concomitant Illness ( )Removed4/2020 Warnings and Precautions, Anticholinergic(antimuscarinic) Effects ( )4/2020----------------------------INDIC ATIONS AND USAGE--------------------------- zyprexa (olanzapine) is an atypical antipsychotic indicated:As oral formulationfor the: Treatment of schizophrenia.

3 ( ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial.( ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemiamay lead clinicians to consider PRESCRIBING other drugs first in adolescents. ( ) Acute treatment ofmanic or mixed episodes associated withbipolarI disorder and maintenance treatmentof bipolarI disorder.( ) Adults: Efficacy was established in threeclinical trials in patients with manic or mixed episodes of bipolarI disorder: two 3- to 4-week trials and one maintenance trial.

4 ( ) Adolescents (ages 13-17): Efficacy was established in one 3-week trial inpatients with manic or mixed episodes associated with bipolar I disorder( ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemiamay lead clinicians to consider PRESCRIBING other drugs first in adolescents. ( ) Medication therapy for pediatric patients with schizophrenia or bipolarI disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( ) Adjunct to valproate or lithium in thetreatment of manic or mixed episodes associated withbipolarI disorder.

5 ( ) Efficacy was established in two 6-week clinical trials in adults ( ). Maintenance efficacy has not been systematically zyprexa IntraMuscular forthe: Treatment of acute agitation associated with schizophrenia and bipolarI mania. ( ) Efficacy was established in three 1-day trials in adults. ( )As zyprexa and Fluoxetine in Combination forthe: Treatment of depressive episodes associated with bipolarI disorder. ( ) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression.

6 ( ) Efficacy was established with Symbyax (olanzapineand fluoxetine in combination)in adults; refer to the product label for AND ADMINISTRATION-----------------------Sch izophrenia in adults ( )Oral: Start at 5-10 mg once daily; Target: 10 mg/day within several daysSchizophrenia in adolescents ( )Oral: Start at mg once daily; Target: 10 mg/dayBipolar I Disorder (manic or mixed episodes) in adults ( )Oral: Start at 10 or 15mg once dailyBipolar I Disorder (manic or mixed episodes) in adolescents ( )Oral: Start at mg once daily; Target: 10 mg/dayBipolar I Disorder (manic ormixed episodes) with lithium or valproate in adults ( )Oral: Start at 10mg once dailyAgitation associated with Schizophrenia and BipolarI Mania in adults( )IM: 10mg (5mg or when clinically warranted)Assess for orthostatic hypotension prior to subsequent dosing (max.)

7 3 doses 2-4 hrs apart)Depressive Episodes associated with BipolarI Disorder in adults ( )Oral in combination with fluoxetine: Start at 5mg of oral olanzapine and 20mg of fluoxetine once dailyDepressive Episodes associated with BipolarI Disorder in children and adolescents ( )Oral in combination with fluoxetine: Start at of oral olanzapine and 20mg of fluoxetine once dailyTreatment Resistant Depression in adults( )Oral in combination with fluoxetine: Start at 5mg of oral olanzapine and 20mg of fluoxetine once daily Lower starting dose recommended in debilitated or pharmacodynamically sensitive patients or patients with predisposition to hypotensive reactions, or with potential for slowed metabolism.

8 ( ) Olanzapine may be given without regard to meals. ( ) zyprexa and Fluoxetine in Combination: Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. ( , ) Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolarI disorder or treatment resistant depression. ( , ) Safety of co-administration of doses above 18mg olanzapine with 75 mg fluoxetine has not been evaluated in adults. ( , ) Safety of co-administration of doses above 12mg olanzapine with 50 mg fluoxetine has not been evaluated in children and adolescents ages 10 to 17.

9 ( )----------------------DOSAGE FORMS AND STRENGTHS--------------------- Tablets (not scored): , 5, ,10, 15, 20mg. (3) Orally Disintegrating Tablets (not scored): 5, 10, 15, 20mg. (3) Intramuscular Injection: 10mg single-dose vial. (3)-------------------------------CONTRA INDICATIONS----------------------------- - None with zyprexa monotherapy.(4) When using ZYPREXAand fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax . (4) When using ZYPREXAin combination with lithium or valproate, refer to the Contraindications section of the package inserts for thoseproducts.

10 (4)2------------------------WARNINGS AND PRECAUTIONS----------------------- Elderly Patients with Dementia-Related Psychosis:Increased risk of death and increased incidence of cerebrovascular adverse events ( , stroke, transient ischemic attack). ( ) Suicide:The possibility of a suicide attempt is inherent in schizophrenia and in bipolarI disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax. ( ) Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring.


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