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ZYPREXA (Olanzapine)

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ZYPREXA (Olanzapine) 1 HIGHLIGHTS OF PRESCRIBING INFORMATION • Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label These highlights do not include all the information needed to use for Symbyax. ZYPREXA safely and effectively. See full prescribing information 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 Schizophrenia in adolescents Oral: Start at 2.5-5 mg once daily; Solution for Intramuscular use (2.1) Target: 10 mg/day Initial U.S. Approval: 1996 Bipolar I Disorder (manic or Oral: Start at 10 or 15 mg once daily WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS mixed episodes) in adults (2.2) WITH DEMENTIA-RELATED PSYCHOSIS Bipolar I Disorder (manic or Oral: Start at 2.5-5 mg once daily; See full prescribing information for complete boxed warning. mixed episodes) in Target: 10 mg/day adolescents (2.2) • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Bipolar I Disorder (manic or Oral: Start at 10 mg once daily ZYPREXA is not approved for the treatment of patients with mixed episodes) with lithium or dementia-related psychosis. (5.1, 5.12, 17.2) valproate in adults (2.2) When using ZYPREXA and fluoxetine in combination, also Agitation associated with IM: 10 mg (5 mg or 7.5 mg when refer to the Boxed Warning section of the package insert for Schizophrenia and Bipolar I clinically warranted) Symbyax. Mania in adults (2.4) Assess for orthostatic hypotension prior to subsequent dosing (max. 3 --------------------------- RECENT MAJOR CHANGES -------------------------- doses 2-4 hrs apart) Warnings and Precautions: Depressive Episodes Oral in combination with fluoxetine: Metabolic Changes (5.4) MM/YYYY associated with Bipolar I Start at 5 mg of oral olanzapine and Disorder in adults (2.5) 20 mg of fluoxetine once daily Hyperprolactinemia (5.13) MM/YYYY Depressive Episodes Oral in combination with fluoxetine: ---------------------------- INDICATIONS AND USAGE --------------------------- associated with Bipolar I Start at 2.5 mg of oral olanzapine ZYPREXA® (olanzapine) is an atypical antipsychotic indicated: Disorder in children and and 20 mg of fluoxetine once daily adolescents (2.5) As oral formulation for the: • Treatment of schizophrenia. (1.1) Treatment Resistant Oral in combination with fluoxetine: • Adults: Efficacy was established in three clinical trials in Depression in adults (2.6) Start at 5 mg of oral olanzapine and patients with schizophrenia: two 6-week trials and one 20 mg of fluoxetine once daily maintenance trial. (14.1) • Adolescents (ages 13-17): Efficacy was established in one 6­ • Lower starting dose recommended in debilitated or week trial in patients with schizophrenia (14.1). The increased pharmacodynamically sensitive patients or patients with potential (in adolescents compared with adults) for weight predisposition to hypotensive reactions, or with potential for gain and dyslipidemia may lead clinicians to consider slowed metabolism. (2.1) prescribing other drugs first in adolescents. (1.1) • Olanzapine may be given without regard to meals. (2.1) • Acute treatment of manic or mixed episodes associated with ZYPREXA and Fluoxetine in Combination: bipolar I disorder and maintenance treatment of bipolar I disorder. • Dosage adjustments, if indicated, should be made with the (1.2) individual components according to efficacy and tolerability. (2.5, • Adults: Efficacy was established in three clinical trials in 2.6) patients with manic or mixed episodes of bipolar I disorder: • Olanzapine monotherapy is not indicated for the treatment of two 3- to 4-week trials and one maintenance trial. (14.2) depressive episodes associated with bipolar I disorder or • Adolescents (ages 13-17): Efficacy was established in one 3­ treatment resistant depression. (2.5, 2.6) week trial in patients with manic or mixed episodes associated • Safety of co-administration of doses above 18 mg olanzapine with with bipolar I disorder (14.2). The increased potential (in 75 mg fluoxetine has not been evaluated in adults. (2.5, 2.6) adolescents compared with adults) for weight gain and • Safety of co-administration of doses above 12 mg olanzapine with dyslipidemia may lead clinicians to consider prescribing other 50 mg fluoxetine has not been evaluated in children and drugs first in adolescents. (1.2) adolescents ages 10 to 17. (2.5) • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough ---------------------- DOSAGE FORMS AND STRENGTHS --------------------- diagnostic evaluation and with careful consideration of the • Tablets (not scored): 2.5, 5, 7.5, 10, 15, 20 mg (3) potential risks. (1.3) • Orally Disintegrating Tablets (not scored): 5, 10, 15, 20 mg (3) • Adjunct to valproate or lithium in the treatment of manic or mixed • Intramuscular Injection: 10 mg vial (3) episodes associated with bipolar I disorder. (1.2) • Efficacy was established in two 6-week clinical trials in adults ------------------------------- CONTRAINDICATIONS ------------------------------ (14.2). Maintenance efficacy has not been systematically • None with ZYPREXA monotherapy. evaluated. • When using ZYPREXA and fluoxetine in combination, also refer to the Contraindications section of the package insert for As ZYPREXA IntraMuscular for the: Symbyax®. (4) • Treatment of acute agitation associated with schizophrenia and • When using ZYPREXA in combination with lithium or valproate, bipolar I mania. (1.4) refer to the Contraindications section of the package inserts for • Efficacy was established in three 1-day trials in adults. (14.3) those products. (4) As ZYPREXA and Fluoxetine in Combination for the: • Treatment of depressive episodes associated with bipolar I ------------------------ WARNINGS AND PRECAUTIONS ----------------------- disorder. (1.5) • Elderly Patients with Dementia-Related Psychosis: Increased risk • Efficacy was established with Symbyax (olanzapine and of death and increased incidence of cerebrovascular adverse fluoxetine in combination); refer to the product label for events (e.g., stroke, transient ischemic attack). (5.1) Symbyax. • Suicide: The possibility of a suicide attempt is inherent in • Treatment of treatment resistant depression. (1.6) schizophrenia and in bipolar I 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 Reference ID: 3675779 2 Warnings and Precautions sections of the package insert for • Schizophrenia (Adolescents) – sedation, weight increased, Symbyax. (5.2) headache, increased appetite, dizziness, abdominal pain, pain in • Neuroleptic Malignant Syndrome: Manage with immediate extremity, fatigue, dry mouth (6.3) discontinuation and close monitoring. (5.3) • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, • Metabolic Changes: Atypical antipsychotic drugs have been dry mouth, constipation, increased appetite, somnolence, associated with metabolic changes including hyperglycemia, dizziness, tremor (6.1) dyslipidemia, and weight gain. (5.4) • Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – • Hyperglycemia and Diabetes Mellitus: In some cases extreme sedation, weight increased, increased appetite, headache, and associated with ketoacidosis or hyperosmolar coma or fatigue, dizziness, dry mouth, abdominal pain, pain in extremity death, has been reported in patients taking olanzapine. (6.3) Patients taking olanzapine should be monitored for symptoms Combination of ZYPREXA and Lithium or Valproate: of hyperglycemia and undergo fasting blood glucose testing at • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, the beginning of, and periodically during, treatment. (5.4) weight gain, increased appetite, dizziness, back pain, • Dyslipidemia: Undesirable alterations in lipids have been constipation, speech disorder, increased salivation, amnesia, observed. Appropriate clinical monitoring is recommended, paresthesia (6.1) including fasting blood lipid testing at the beginning of, and periodically during, treatment. (5.4) ZYPREXA and Fluoxetine in Combination: Also refer to the Adverse • Weight Gain: Potential consequences of weight gain should Reactions section of the package insert for Symbyax. (6) be considered. Patients should receive regular monitoring of ZYPREXA IntraMuscular for Injection: weight. (5.4) • Agitation with Schizophrenia and Bipolar I Mania (Adults) – • Tardive Dyskinesia: Discontinue if clinically appropriate. (5.5) somnolence (6.1) • Orthostatic Hypotension: Orthostatic hypotension associated with To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly dizziness, tachycardia, bradycardia and, in some patients, and Company at 1-800-LillyRx (1-800-545-5979) or FDA at syncope, may occur especially during initial dose titration. Use 1-800-FDA-1088 or www.fda.gov/medwatch caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic ------------------------------- DRUG INTERACTIONS ------------------------------ responses. (5.6) • Diazepam: May potentiate orthostatic hypotension. (7.1, 7.2) • Leukopenia, Neutropenia,
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