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PRISTIQ (Desvenlafaxine) Extended-Release Tablets, Oral Bleeding Associated with the Concomitant Use of PRISTIQ and Initial U.S

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PRISTIQ (Desvenlafaxine) Extended-Release Tablets, Oral Bleeding Associated with the Concomitant Use of PRISTIQ and Initial U.S HIGHLIGHTS OF PRESCRIBING INFORMATION • Elevated Blood Pressure: Has occurred with PRISTIQ. These highlights do not include all the information needed to use Hypertension should be controlled before initiating treatment. PRISTIQ safely and effectively. See full prescribing information for Monitor blood pressure regularly during treatment (5.3). PRISTIQ. • Abnormal Bleeding: PRISTIQ may increase the risk of ® bleeding events. Patients should be cautioned about the risk of PRISTIQ (desvenlafaxine) Extended-Release Tablets, oral bleeding associated with the concomitant use of PRISTIQ and Initial U.S. Approval: 2008 NSAIDs, aspirin, or other drugs that affect coagulation (5.4). WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS • Narrow-angle Glaucoma: Mydriasis has occurred with PRISTIQ. Patients with raised intraocular pressure or those at See full prescribing information for complete boxed warning. risk of angle-closure glaucoma should be monitored (5.5). Increased risk of suicidal thinking and behavior in children, adolescents • Activation of Mania/Hypomania: Has occurred. Use and young adults taking antidepressants for major depressive disorder cautiously in patients with Bipolar Disorder. Caution patients (MDD) and other psychiatric disorders. PRISTIQ is not approved for use about the risk of activation of mania/hypomania (5.6). in pediatric patients (5.1). • Cardiovascular/Cerebrovascular Disease: Use cautiously in patients with cardiovascular or cerebrovascular disease (5.7). ———————— INDICATIONS AND USAGE ——————— • Cholesterol and Triglyceride Elevation: Have occurred. Use — cautiously in patients with lipid metabolism disorders. Consider PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor monitoring serum cholesterol and triglyceride (5.8). (SNRI), is indicated for the treatment of major depressive disorder • Discontinuation Symptoms: Have occurred. Taper the dose [MDD] (1). when possible and monitor for discontinuation symptoms (5.9). ——————— DOSAGE AND ADMINISTRATION ————— • Renal Impairment: Reduces the clearance of PRISTIQ. Dosage — adjustment is necessary in severe and ESRD. In moderate renal • Recommended dose: 50 mg once daily with or without food impairment, the dose should not exceed 50 mg/day (5.10). (2.1). • Seizure: Can occur. Use cautiously in patients with seizure • There was no evidence that doses greater than 50 mg/day confer disorder (5.11). any additional benefit (2.1). • Hyponatremia: Can occur in association with SIADH (5.12). • When discontinuing treatment, gradual dose reduction is • Drugs Containing Desvenlafaxine or Venlafaxine: Should not recommended whenever possible (2.1 and 5.9). be used concomitantly with PRISTIQ (5.13). • Tablets should be taken whole; do not divide, crush, chew, or • Interstitial Lung Disease and Eosinophilic Pneumonia: Can dissolve (2.1). occur (5.14). • Renal Impairment: The recommended dose in patients with ————————— ADVERSE REACTIONS ————————— moderate renal impairment is 50 mg/day. The recommended Adverse reactions in patients in short-term fixed-dose studies (incidence dose in patients with severe renal impairment and end-stage ≥ 5% and twice the rate of placebo in the 50 or 100 mg dose groups) renal disease (ESRD) is 50 mg every other day. The dose were: nausea, dizziness, insomnia, hyperhidrosis, constipation, should not be escalated in patients with moderate or severe somnolence, decreased appetite, anxiety, and specific male sexual renal impairment or ESRD (2.2). function disorders (6.1). • Hepatic Impairment: Dose escalation above 100 mg/day is not recommended (2.2). To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 —————— DOSAGE FORMS AND STRENGTHS —————— or www.fda.gov/medwatch • PRISTIQ tablets are available as 50 and 100 mg tablets (3). ——————— USE IN SPECIFIC POPULATIONS —————— • Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine (3). • Dosage adjustment is recommended in patients with severe renal impairment and end-stage renal disease. The dose should not be ————————— CONTRAINDICATIONS ———————— escalated in moderate to severe impairment or in ESRD (2.2, • Hypersensitivity to desvenlafaxine succinate, venlafaxine 8.6 and 12.6). hydrochloride or any excipients in the PRISTIQ formulation • There is an increased incidence of orthostatic hypotension in (4.1). PRISTIQ treated patients ≥ 65 years (6.1 and 8.5). • Do not use with an MAOI or within 14 days of stopping an • For elderly patients, the possibility of reduced renal clearance of MAOI. Allow 7 days after stopping PRISTIQ before starting an desvenlafaxine should be considered when determining dose MAOI (4.2). (2.2). Only administer PRISTIQ to pregnant or breastfeeding women if ——————— WARNINGS AND PRECAUTIONS —————— • the expected benefits outweigh the possible risks (8.1 and 8.3). • Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk (5.1). Revised: See 17 for PATIENT COUNSELING INFORMATION and • Serotonin Syndrome or Neuroleptic Malignant Syndrome the FDA-approved Medication Guide. (NMS)-like Reactions: Serotonin syndrome or NMS-like 12/2010 reactions have been reported with SSRIs and SNRIs. Discontinue PRISTIQ and initiate supportive treatment (5.2). 1 Reference ID: 2897618 FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 2 DOSAGE AND ADMINISTRATION 8.2 Labor and Delivery 2.1 Initial Treatment of Major Depressive Disorder 8.3 Nursing Mothers 2.2 Special Populations 8.4 Pediatric Use 2.3 Maintenance/Continuation/Extended Treatment 8.5 Geriatric Use 2.4 Discontinuing PRISTIQ 8.6 Renal Impairment 2.5 Switching Patients From Other Antidepressants to PRISTIQ 8.7 Hepatic Impairment 2.6 Switching Patients To or From a Monoamine Oxidase Inhibitor 9 DRUG ABUSE AND DEPENDENCE (MAOI) 9.1 Controlled Substance 3 DOSAGE FORMS AND STRENGTHS 9.2 Abuse and Dependence 4 CONTRAINDICATIONS 10 OVERDOSAGE 4.1 Hypersensitivity 10.1 Human Experience with Overdosage 4.2 Monoamine Oxidase Inhibitors 10.2 Management of Overdosage 5 WARNINGS AND PRECAUTIONS 11 DESCRIPTION 5.1 Clinical Worsening and Suicide Risk 12 CLINICAL PHARMACOLOGY 5.2 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)­ 12.1 Mechanism of Action like Reactions 12.2 Pharmacodynamics 5.3 Elevated Blood Pressure 12.3 Pharmacokinetics 5.4 Abnormal Bleeding 12.4 Absorption and Distribution 5.5 Narrow-angle Glaucoma 12.5 Metabolism and Elimination 5.6 Activation of Mania/Hypomania 12.6 Special Populations 5.7 Cardiovascular/Cerebrovascular Disease 13 NONCLINICAL TOXICOLOGY 5.8 Serum Cholesterol and Triglyceride Elevation 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.9 Discontinuation of Treatment with PRISTIQ 14 CLINICAL STUDIES 5.10 Renal Impairment 16 HOW SUPPLIED/STORAGE AND HANDLING 5.11 Seizure 17 PATIENT COUNSELING INFORMATION 5.12 Hyponatremia 17.1 Suicide Risk 5.13 Co-administration of Drugs Containing Desvenlafaxine and 17.2 Concomitant Medication Venlafaxine 17.3 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)­ 5.14 Interstitial Lung Disease and Eosinophilic Pneumonia like Reactions 6 ADVERSE REACTIONS 17.4 Elevated Blood Pressure 6.1 Clinical Studies Experience 17.5 Abnormal Bleeding 6.2 Adverse Reactions Identified During Post-Approval Use 17.6 Narrow-angle Glaucoma 6.3 Adverse Reactions Reported With Other SNRIs 17.7 Activation of Mania/Hypomania 7 DRUG INTERACTIONS 17.8 Cardiovascular/Cerebrovascular Disease 7.1 Central Nervous System (CNS)-Active Agents 17.9 Serum Cholesterol and Triglyceride Elevation 7.2 Monoamine Oxidase Inhibitors (MAOI) 17.10 Discontinuation 7.3 Serotonergic Drugs 17.11 Switching Patients From Other Antidepressants to PRISTIQ 7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and 17.12 Interference with Cognitive and Motor Performance Warfarin) 17.13 Alcohol 7.5 Ethanol 17.14 Allergic Reactions 7.6 Potential for Other Drugs to Affect Desvenlafaxine 17.15 Pregnancy 7.7 Potential for Desvenlafaxine to Affect Other Drugs 17.16 Nursing 7.8 P-glycoprotein Transporter 17.17 Residual Inert Matrix Tablet 7.9 Electroconvulsive Therapy * Sections or subsections omitted from the full prescribing information are not listed 2 Reference ID: 2897618 FULL PRESCRIBING INFORMATION WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PRISTIQ® or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PRISTIQ is not approved for use in pediatric patients [see Warnings and Precautions
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