HIGHLIGHTS OF PRESCRIBING INFORMATION serious cardiac ...

1 1. HIGHLIGHTS OF PRESCRIBING INFORMATION serious cardiac problems that may place them at increased These HIGHLIGHTS do not include all the INFORMATION needed to use vulnerability to its noradrenergic effects. Consideration should be STRATTERA safely and effectively. See full PRESCRIBING given to not using STRATTERA in adults with clinically significant INFORMATION for STRATTERA. cardiac abnormalities. ( ).. STRATTERA (atomoxetine) CAPSULES for Oral Use Emergent Cardiovascular Symptoms Patients should undergo Initial Approval: 2002 prompt cardiac evaluation. ( ). Effects on Blood Pressure and Heart Rate Increase in blood WARNING: SUICIDAL IDEATION IN CHILDREN AND pressure and heart rate; orthostasis and syncope may occur. Use ADOLESCENTS with caution in patients with hypertension, tachycardia, or See full PRESCRIBING INFORMATION for complete boxed warning.

2 Cardiovascular or cerebrovascular disease. ( ). Increased risk of suicidal ideation in children or adolescents Emergent Psychotic or Manic Symptoms Consider discontinuing ( ) treatment if such new symptoms occur. ( ). Bipolar Disorder Screen patients to avoid possible induction of a No suicides occurred in clinical trials ( ) mixed/manic episode. ( ). Patients started on therapy should be monitored closely ( ) Aggressive behavior or hostility should be monitored. ( ). Possible allergic reactions, including anaphylactic reactions, ---------------------------RECENT MAJOR CHANGES--------------------------- angioneurotic edema, urticaria, and rash. ( ). None. Effects on Urine Outflow Urinary hesitancy and retention may occur. ( ). ------------------------INDICATIONS AND USAGE------------------------------- Priapism Prompt medical attention is required in the event of.

3 STRATTERA is a selective norepinephrine reuptake inhibitor suspected priapism. ( , ). indicated for the treatment of Attention-Deficit/Hyperactivity Disorder Growth Height and weight should be monitored in pediatric (ADHD). ( ) patients. ( ). Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients -----------------------DOSAGE AND ADMINISTRATION----------------------- known to be CYP2D6 PMs Dose adjustment of STRATTERA. Initial, Target and Maximum Daily Dose ( ) may be necessary. ( ). (Acute and Maintenance/Extended Treatment) ------------------------------ADVERSE REACTIONS------------------------------- Body Weight Initial Daily Target Total Maximum Total Most common adverse reactions ( 5% and at least twice the Dose Daily Dose Daily Dose incidence of placebo patients). Children and mg/kg mg/kg mg/kg Child and Adolescent Clinical Trials Nausea, vomiting, fatigue, adolescents up decreased appetite, abdominal pain, and somnolence.

4 ( ). to 70 kg Adult Clinical Trials Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. Children and 40 mg 80 mg 100 mg ( ). adolescents over 70 kg and To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly adults and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800- FDA-1088 or Dosing adjustment Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). ( , -------------------------------DRUG INTERACTIONS---------------------------- -- ) Monoamine Oxidase Inhibitors. ( , ). CYP2D6 Inhibitors - Concomitant use may increase atomoxetine ---------------------DOSAGE FORMS AND STRENGTHS---------------------- steady-state plasma concentrations in EMs. ( ). Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, Antihypertensive Drugs and Pressor Agents - Possible effects on 60, 80, or 100 mg of atomoxetine.

5 (3, 11, 16) blood pressure. ( ). Albuterol (or other beta2 agonists) - Action of albuterol on ----------------------------CONTRAINDICA TIONS--------------------------------- cardiovascular system can be potentiated. ( ). Hypersensitivity to atomoxetine or other constituents of product. ( ) ---------------------------USE IN SPECIFIC POPULATIONS-------------------- STRATTERA use within 2 weeks after discontinuing MAOI or Pregnancy/Lactation - Pregnant or nursing women should not use other drugs that affect brain monoamine concentrations. ( , ) unless potential benefit justifies potential risk to fetus or infant. Narrow Angle Glaucoma. ( ) ( , ). Pheochromocytoma or history of pheochromocytoma. ( ) Hepatic Insufficiency - Increased exposure (AUC) to atomoxetine Severe Cardiovascular Disorders that might deteriorate with than with normal subjects in EM subjects with moderate (Child- clinically important increases in HR and BP.)

6 ( ) Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C). (4-fold increase). ( ). ------------------------WARNINGS AND PRECAUTIONS----------------------- Renal Insufficiency - Higher systemic exposure to atomoxetine Suicidal Ideation Monitor for suicidality, clinical worsening, and than healthy subjects for EM subjects with end stage renal unusual changes in behavior. ( ) disease - no difference when exposure corrected for mg/kg dose. Severe Liver Injury Should be discontinued and not restarted in ( ). patients with jaundice or laboratory evidence of liver injury. ( ) Patients with Concomitant Illness - Does not worsen tics in serious Cardiovascular Events Sudden death, stroke and patients with ADHD and comorbid Tourette's Disorder. ( ). myocardial infarction have been reported in association with Patients with Concomitant Illness Does not worsen anxiety in atomoxetine treatment.

7 Patients should have a careful history and patients with ADHD and comorbid Anxiety Disorders. ( ). physical exam to assess for presence of cardiovascular disease. STRATTERA generally should not be used in children or See 17 for PATIENT COUNSELING INFORMATION and the FDA- adolescents with known serious structural cardiac abnormalities, approved Medication Guide cardiomyopathy, serious heart rhythm abnormalities, or other Revised: 05/2017. FULL PRESCRIBING INFORMATION : CONTENTS*. WARNING: SUICIDAL IDEATION IN CHILDREN AND Need for Comprehensive Treatment Program ADOLESCENTS 2 DOSAGE AND ADMINISTRATION. 1 INDICATIONS AND USAGE Acute Treatment Attention-Deficit/Hyperactivity Disorder (ADHD) Maintenance/Extended Treatment Diagnostic Considerations General Dosing INFORMATION 2. Dosing in Specific Populations Renal Insufficiency 3 DOSAGE FORMS AND STRENGTHS Gender Ethnic Origin 4 CONTRAINDICATIONS Patients with Concomitant Illness Hypersensitivity Monoamine Oxidase Inhibitors (MAOI) 9 DRUG ABUSE AND DEPENDENCE.

8 Narrow Angle Glaucoma Controlled Substance Pheochromocytoma Abuse Severe Cardiovascular Disorders Dependence 5 WARNINGS AND PRECAUTIONS 10 OVERDOSAGE. Suicidal Ideation Human Experience Severe Liver Injury Management of Overdose serious Cardiovascular Events 11 DESCRIPTION. Effects on Blood Pressure and Heart Rate 12 CLINICAL PHARMACOLOGY. Emergence of New Psychotic or Manic Symptoms Mechanism of Action Screening Patients for Bipolar Disorder Pharmacodynamics Aggressive Behavior or Hostility Pharmacokinetics Allergic Events Effects on Urine Outflow from the Bladder 13 NONCLINICAL TOXICOLOGY. Priapism Carcinogenesis, Mutagenesis, Impairment of Fertility Effects on Growth 14 CLINICAL STUDIES. Laboratory Tests ADHD studies in Children and Adolescents Concomitant Use of Potent CYP2D6 Inhibitors or Use in ADHD studies in Adults patients who are known to be CYP2D6 PMs 16 HOW SUPPLIED/STORAGE AND HANDLING.

9 6 ADVERSE REACTIONS How Supplied Clinical Trials Experience Storage and Handling Postmarketing Spontaneous Reports 17 PATIENT COUNSELING INFORMATION . 7 DRUG INTERACTIONS General INFORMATION Monoamine Oxidase Inhibitors Suicide Risk Effect of CYP2D6 Inhibitors on Atomoxetine Severe Liver Injury Antihypertensive Drugs and Pressor Agents Aggression or Hostility Albuterol Priapism Effect of Atomoxetine on P450 Enzymes Ocular Irritant Alcohol Drug-Drug Interaction Methylphenidate Pregnancy Drugs Highly Bound to Plasma Protein Food Drugs that Affect Gastric pH Missed Dose 8 USE IN SPECIFIC POPULATIONS Interference with Psychomotor Performance Pregnancy Labor and Delivery *Sections or subsections omitted from the full PRESCRIBING INFORMATION Nursing Mothers are not listed Pediatric Use Geriatric Use Hepatic Insufficiency FULL PRESCRIBING INFORMATION .

10 WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS. STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.