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ZYPREXA Safely and Effectively

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1 HIGHLIGHTS OF PRESCRIBING INFORMATION • Efficacy was established with Symbyax (olanzapine and These highlights do not include all the information needed to use fluoxetine in combination) in adults; refer to the product label ZYPREXA safely and effectively. See full prescribing information for Symbyax. for ZYPREXA. ------------------------DOSAGE AND ADMINISTRATION----------------------- ZYPREXA (olanzapine) Tablet for Oral use Schizophrenia in adults (2.1) Oral: Start at 5-10 mg once daily; ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Target: 10 mg/day within several Oral use days ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Schizophrenia in adolescents Oral: Start at 2.5-5 mg once daily; Initial U.S. Approval: 1996 (2.1) Target: 10 mg/day Bipolar I Disorder (manic or Oral: Start at 10 or 15 mg once WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS mixed episodes) in adults daily WITH DEMENTIA-RELATED PSYCHOSIS (2.2) See full prescribing information for complete boxed warning. Bipolar I Disorder (manic or Oral: Start at 2.5-5 mg once daily; • Elderly patients with dementia-related psychosis treated with mixed episodes) in Target: 10 mg/day antipsychotic drugs are at an increased risk of death. adolescents (2.2) ZYPREXA is not approved for the treatment of patients with dementia-related psychosis. (5.1, 8.5, 17) Bipolar I Disorder (manic or Oral: Start at 10 mg once daily mixed episodes) with lithium When using ZYPREXA and fluoxetine in combination, also or valproate in adults (2.2) refer to the Boxed Warning section of the package insert for Symbyax. Agitation associated with IM: 10 mg (5 mg or 7.5 mg when Schizophrenia and Bipolar I clinically warranted) --------------------------- RECENT MAJOR CHANGES -------------------------- Mania in adults (2.4) Assess for orthostatic hypotension prior to subsequent dosing (max. Warnings and Precautions, Tardive Dyskinesia (5.6) 10/2019 3 doses 2-4 hrs apart) Warnings and Precautions, Use in Patients Depressive Episodes Oral in combination with with Concomitant Illness (5.14) Removed 4/2020 associated with Bipolar I fluoxetine: Start at 5 mg of oral Warnings and Precautions, Anticholinergic Disorder in adults (2.5) olanzapine and 20 mg of fluoxetine once daily (antimuscarinic) Effects (5.14) 4/2020 Depressive Episodes Oral in combination with ---------------------------- INDICATIONS AND USAGE --------------------------- associated with Bipolar I fluoxetine: Start at 2.5 mg of oral ZYPREXA® (olanzapine) is an atypical antipsychotic indicated: Disorder in children and olanzapine and 20 mg of adolescents (2.5) fluoxetine once daily As oral formulation for the: • Treatment of schizophrenia. (1.1) Treatment Resistant Oral in combination with • Adults: Efficacy was established in three clinical trials in Depression in adults (2.6) fluoxetine: Start at 5 mg of oral patients with schizophrenia: two 6-week trials and one olanzapine and 20 mg of maintenance trial. (14.1) fluoxetine once daily • Adolescents (ages 13-17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased • Lower starting dose recommended in debilitated or potential (in adolescents compared with adults) for weight pharmacodynamically sensitive patients or patients with gain and dyslipidemia may lead clinicians to consider predisposition to hypotensive reactions, or with potential for prescribing other drugs first in adolescents. (1.1) slowed metabolism. (2.1) • Acute treatment of manic or mixed episodes associated with • Olanzapine may be given without regard to meals. (2.1) bipolar I disorder and maintenance treatment of bipolar I disorder. ZYPREXA and Fluoxetine in Combination: (1.2) • Dosage adjustments, if indicated, should be made with the • Adults: Efficacy was established in three clinical trials in individual components according to efficacy and tolerability. (2.5, patients with manic or mixed episodes of bipolar I disorder: 2.6) two 3- to 4-week trials and one maintenance trial. (14.2) • Olanzapine monotherapy is not indicated for the treatment of • Adolescents (ages 13-17): Efficacy was established in one 3- depressive episodes associated with bipolar I disorder or week trial in patients with manic or mixed episodes associated treatment resistant depression. (2.5, 2.6) with bipolar I disorder (14.2). The increased potential (in • Safety of co-administration of doses above 18 mg olanzapine with adolescents compared with adults) for weight gain and 75 mg fluoxetine has not been evaluated in adults. (2.5, 2.6) dyslipidemia may lead clinicians to consider prescribing other • Safety of co-administration of doses above 12 mg olanzapine with drugs first in adolescents. (1.2) 50 mg fluoxetine has not been evaluated in children and • Medication therapy for pediatric patients with schizophrenia or adolescents ages 10 to 17. (2.5) bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the ----------------------DOSAGE FORMS AND STRENGTHS--------------------- potential risks. (1.3) • Tablets (not scored): 2.5, 5, 7.5, 10, 15, 20 mg. (3) • Adjunct to valproate or lithium in the treatment of manic or mixed • Orally Disintegrating Tablets (not scored): 5, 10, 15, 20 mg. (3) episodes associated with bipolar I disorder. (1.2) • Intramuscular Injection: 10 mg single-dose vial. (3) • Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically ------------------------------- CONTRAINDICATIONS ------------------------------ evaluated. • None with ZYPREXA monotherapy. (4) • When using ZYPREXA and fluoxetine in combination, also refer As ZYPREXA IntraMuscular for the: to the Contraindications section of the package insert for • Treatment of acute agitation associated with schizophrenia and Symbyax®. (4) bipolar I mania. (1.4) • When using ZYPREXA in combination with lithium or valproate, • Efficacy was established in three 1-day trials in adults. (14.3) refer to the Contraindications section of the package inserts for As ZYPREXA and Fluoxetine in Combination for the: those products. (4) • Treatment of depressive episodes associated with bipolar I disorder. (1.5) • Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. • Treatment of treatment resistant depression. (1.6) 2 ------------------------WARNINGS AND PRECAUTIONS ----------------------- -------------------------------ADVERSE REACTIONS------------------------------ • Elderly Patients with Dementia-Related Psychosis: Increased risk Most common adverse reactions (≥5% and at least twice that for of death and increased incidence of cerebrovascular adverse placebo) associated with: events (e.g., stroke, transient ischemic attack). (5.1) • Suicide: The possibility of a suicide attempt is inherent in Oral Olanzapine Monotherapy: schizophrenia and in bipolar I disorder, and close supervision of • Schizophrenia (Adults) – postural hypotension, constipation, high-risk patients should accompany drug therapy; when using in weight gain, dizziness, personality disorder, akathisia. (6.1) combination with fluoxetine, also refer to the Boxed Warning and • Schizophrenia (Adolescents) – sedation, weight increased, Warnings and Precautions sections of the package insert for headache, increased appetite, dizziness, abdominal pain, pain in Symbyax. (5.2) extremity, fatigue, dry mouth. (6.1) • Neuroleptic Malignant Syndrome: Manage with immediate • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, discontinuation and close monitoring. (5.3) dry mouth, constipation, increased appetite, somnolence, • Drug Reaction with Eosinophilia and Systemic Symptoms dizziness, tremor. (6.1) (DRESS): Discontinue if DRESS is suspected. (5.4) • Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – • Metabolic Changes: Atypical antipsychotic drugs have been sedation, weight increased, increased appetite, headache, associated with metabolic changes including hyperglycemia, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity. dyslipidemia, and weight gain. (5.5) (6.1) • Hyperglycemia and Diabetes Mellitus: In some cases extreme Combination of ZYPREXA and Lithium or Valproate: and associated with ketoacidosis or hyperosmolar coma or • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, death, has been reported in patients taking olanzapine. weight gain, increased appetite, dizziness, back pain, Patients taking olanzapine should be monitored for symptoms constipation, speech disorder, increased salivation, amnesia, of hyperglycemia and undergo fasting blood glucose testing at paresthesia. (6.1) the beginning of, and periodically during, treatment. (5.5) ZYPREXA and Fluoxetine in Combination: Also refer to the Adverse • Dyslipidemia: Undesirable alterations in lipids have been Reactions section of the package insert for Symbyax. (6) observed. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and ZYPREXA IntraMuscular for Injection: periodically during, treatment. (5.5) • Agitation with Schizophrenia and Bipolar I Mania (Adults) – • Weight Gain: Potential consequences of weight gain should somnolence. (6.1) be considered. Patients should receive regular monitoring of To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly weight. (5.5) and Company at 1-800-LillyRx (1-800-545-5979) or FDA at • Tardive Dyskinesia: Discontinue if clinically
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