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Symbyax-Pi.Pdf 1 HIGHLIGHTS OF PRESCRIBING INFORMATION • Weight gain: Consider potential consequences of weight These highlights do not include all the information needed to use gain. Monitor weight regularly (5.5) SYMBYAX safely and effectively. See full prescribing information • Serotonin Syndrome: Serotonin syndrome has been reported with for SYMBYAX. SSRIs and SNRIs, including SYMBYAX, both when taken alone, but especially when co-administered with other serotonergic SYMBYAX (olanzapine and fluoxetine) capsules for oral use agents (including triptans, tricyclic antidepressants, fentanyl, Initial U.S. Approval: 2003 lithium, tramadol, tryptophan, buspirone, amphetamines, and St. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS and John's Wort). If such symptoms occur, discontinue SYMBYAX INCREASED MORTALITY IN ELDERLY PATIENTS WITH and initiate supportive treatment. If concomitant use of SYMBYAX DEMENTIA-RELATED PSYCHOSIS with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin See full prescribing information for complete boxed warning. syndrome, particularly during treatment initiation and dose • Increased risk of suicidal thinking and behavior in children, increases (5.6). adolescents, and young adults taking antidepressants. • Angle-Closure Glaucoma: Angle-closure glaucoma has occurred SYMBYAX is not approved for use in children less than 10 in patients with untreated anatomically narrow angles treated with years of age. Monitor for worsening and emergence of antidepressants (5.7) suicidal thoughts and behaviors (5.1, 8.4). • Allergic Reactions and Rash: Discontinue upon appearance of • Elderly patients with dementia-related psychosis treated with rash or allergic phenomena (5.8) antipsychotic drugs are at an increased risk of death. • Activation of Mania/Hypomania: Screen for Bipolar Disorder and SYMBYAX is not approved for the treatment of patients with monitor for activation of mania/hypomania (5.9) dementia-related psychosis (5.2). • Tardive Dyskinesia: Discontinue if clinically appropriate (5.10) • Orthostatic Hypotension: Can be associated with bradycardia and --------------------------- RECENT MAJOR CHANGES -------------------------- syncope. Risk is increased during initial dose titration. Use Dosage and Administration (2.3) 10/2020 caution in patients with cardiovascular disease or cerebrovascular Warnings and Precautions, Sexual Dysfunction (5.26) 9/2021 disease, and those conditions that could affect hemodynamic responses (5.11) ---------------------------- INDICATIONS AND USAGE --------------------------- ® • Leukopenia, Neutropenia, and Agranulocytosis: Has been SYMBYAX combines olanzapine, an atypical antipsychotic and reported with antipsychotics, including SYMBYAX. Patients with a fluoxetine, a selective serotonin reuptake inhibitor, indicated for history of a clinically significant low white blood cell count (WBC) treatment of: or drug induced leukopenia/neutropenia should have their • Acute Depressive Episodes Associated with Bipolar I Disorder (1) complete blood count (CBC) monitored frequently during the first • Treatment Resistant Depression (1) few months of therapy. Consider discontinuing SYMBYAX at the ------------------------DOSAGE AND ADMINISTRATION----------------------- first sign of a clinically significant decline in WBC in the absence • Adult Starting Dose: 6 mg olanzapine with 25 mg fluoxetine of other causative factors (5.13) (6 mg/25 mg, once daily in the evening (2.1, 2.2) • Seizures: Use cautiously in patients with a history of seizures or • Adult Maximum Dose: 12 mg/50 mg once daily (2.1, 2.2). with conditions that lower the seizure threshold (5.15) • Pediatric Bipolar Depression Starting Dose: 3 mg/25 mg once • Abnormal Bleeding: SSRIs increase the risk of bleeding. Use with daily (for ages 10 to 17 years) (2.1) NSAIDs, aspirin, warfarin, or other drugs that affect coagulation • Pediatric Bipolar Depression Maximum Dose: 12 mg/50 mg (2.1) may potentiate the risk of gastrointestinal or other bleeding (5.16) • Starting dose in patients predisposed to hypotensive reactions, • Hyponatremia: Can occur in association with syndrome of hepatic impairment, or with potential for slowed metabolism: inappropriate antidiuretic hormone (SIADH). Consider 3 mg/25 mg to 6 mg/25 mg. Escalate dose cautiously (2.3) discontinuing SYMBYAX if symptomatic hyponatremia occurs (SIADH) (5.17) ----------------------DOSAGE FORMS AND STRENGTHS--------------------- • Potential for Cognitive and Motor Impairment: Has potential to • Capsules: 3 mg/25 mg, 6 mg/25 mg, 6 mg/50 mg, and impair judgment, thinking, and motor skills. Caution patients about 12 mg/50 mg (mg olanzapine/mg equivalent fluoxetine) (3) operating machinery (5.18) • QT Prolongation: QT prolongation and ventricular arrhythmia ------------------------------- CONTRAINDICATIONS ------------------------------ including Torsade de Pointes have been reported with fluoxetine. • Monoamine Oxidase Inhibitors (MAOI): Because of the risk of Use with caution in conditions that predispose to arrhythmias or serotonin syndrome, do not use MAOIs intended to treat increased fluoxetine exposure. Use cautiously in patients with risk psychiatric disorders with SYMBYAX or within 5 weeks of factors for QT prolongation (4.2, 5.20) stopping treatment with SYMBYAX. Do not use SYMBYAX within • Anticholinergic (antimuscarinic) Effects: Use with caution with 14 days of stopping an MAOI intended to treat psychiatric other anticholinergic drugs and in patients with urinary retention, disorders. In addition, do not start SYMBYAX in a patient who is prostatic hypertrophy, constipation, history of paralytic ileus or being treated with linezolid or intravenous methylene blue. (4.1) related conditions (5.21) • Pimozide: Do not use. Risk of QT interval prolongation (4.2, 5.20, • Hyperprolactinemia: May elevate prolactin levels (5.22) 7.7, 7.8) • Long Elimination Half-Life of Fluoxetine: Changes in dose will not • Thioridazine: Do not use. Risk of QT interval prolongation. Do not be fully reflected in plasma for several weeks (5.24) use thioridazine within 5 weeks of discontinuing SYMBYAX (4.2, • Sexual Dysfunction: SYMBYAX use may cause symptoms of 5.20, 7.7, 7.8) sexual dysfunction (5.26) ------------------------WARNINGS AND PRECAUTIONS ----------------------- -------------------------------ADVERSE REACTIONS------------------------------ • Neuroleptic Malignant Syndrome: Manage with immediate Most common adverse reactions (≥5% and at least twice that for discontinuation and close monitoring (5.3) placebo) in adults: sedation, weight increased, appetite increased, dry • Drug Reaction with Eosinophilia and Systemic Symptoms mouth, fatigue, edema, tremor, disturbance in attention, blurred vision. (DRESS): Discontinue if DRESS is suspected (5.4) Children and adolescents: sedation, weight increased, appetite • Metabolic Changes: Atypical antipsychotic drugs have been increased, tremor, triglyceride increased, hepatic enzymes increased associated with metabolic changes including hyperglycemia, (6.1) dyslipidemia, and weight gain (5.5) • Hyperglycemia and Diabetes Mellitus: In some cases To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly extreme and associated with ketoacidosis or hyperosmolar and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800- coma or death. Monitor for symptoms of hyperglycemia. FDA-1088 or www.fda.gov/medwatch Perform fasting blood glucose testing before beginning, and ------------------------------- DRUG INTERACTIONS ------------------------------ periodically during treatment. (5.5) • Monoamine Oxidase Inhibitor (MAOI): (2.4, 2.5, 4.1, 5.6, 7.1) • Dyslipidemia: Appropriate clinical monitoring is • Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of recommended, including fasting blood lipid testing before CYP2D6 enzyme pathway (7.7) beginning, and periodically during, treatment (5.5) 2 • Tricyclic Antidepressants (TCAs): Monitor TCA levels during • Drugs that Prolong the QT Interval: Do not use SYMBYAX in coadministration with SYMBYAX or when SYMBYAX has been combination with thioridazine or pimozide. Use SYMBYAX with recently discontinued (5.6, 7.7) caution in combination with other drugs that prolong the QT • CNS Acting Drugs: Caution is advised if the concomitant interval (4.2, 5.20, 7.7, 7.8) administration of SYMBYAX and other CNS-active drugs is required (7.2) ------------------------USE IN SPECIFIC POPULATIONS----------------------- • Antihypertensive Agent: Enhanced antihypertensive effect (7.7) • Levodopa and Dopamine Agonists: May antagonize • Pregnancy: SSRI use, particularly later in pregnancy, may levodopa/dopamine agonists (7.7) increase the risk for persistent pulmonary hypertension and • Benzodiazepines: May potentiate orthostatic hypotension and symptoms of poor adaptation (respiratory distress, temperature sedation (7.6, 7.7) instability, feeding difficulty, hypotonia, irritability, tremor) in the • Clozapine: May elevate clozapine levels (7.7) neonate. Olanzapine may cause extrapyramidal symptoms and/or • Haloperidol: Elevated haloperidol levels have been observed (7.7) withdrawal symptoms in neonates with third trimester exposure • Carbamazepine: Potential for elevated carbamazepine levels and (8.1) clinical anticonvulsant toxicity (7.7) • Pediatric Use: Safety and efficacy of Symbyax for the treatment of • Phenytoin: Potential for elevated phenytoin levels and clinical bipolar I depression in patients under 10 years of age have not anticonvulsant toxicity (7.7)
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