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TRINTELLIX Safely and Effectively

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TRINTELLIX Safely and Effectively HIGHLIGHTS OF PRESCRIBING INFORMATION -------------------------------CONTRAINDICATIONS-----------------------------­ These highlights do not include all the information needed to use • Hypersensitivity to vortioxetine or any components of the TRINTELLIX safely and effectively. See full prescribing TRINTELLIX formulation (4). information for TRINTELLIX. • Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs TRINTELLIX (vortioxetine) tablets, for oral use intended to treat psychiatric disorders with TRINTELLIX or within Initial U.S. Approval: 2013 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended to treat WARNING: SUICIDAL THOUGHTS AND BEHAVIORS psychiatric disorders. In addition, do not start TRINTELLIX in a See full prescribing information for complete boxed warning. patient who is being treated with linezolid or intravenous • Increased risk of suicidal thinking and behavior in pediatric and methylene blue (4). young adult patients taking antidepressants. -----------------------WARNINGS AND PRECAUTIONS-----------------------­ • • Closely monitor for worsening and emergence of suicidal Serotonin Syndrome: Increased risk when co-administered with thoughts and behaviors (5.1). other serotonergic agents (SSRIs, SNRIs, and triptans), but also when taken alone. If it occurs, discontinue TRINTELLIX and • TRINTELLIX is not approved for use in pediatric patients (8.4). initiate supportive measures (5.2). • Increased Risk of Bleeding: Concomitant use of aspirin, ----------------------------RECENT MAJOR CHANGES-------------------------­ nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, Boxed Warning 1/2021 warfarin, or other drugs that affect coagulation may increase risk Dosage and Administration, Maintenance/ (5.3). Continuation/Extended Treatment (2.2) Removed 11/2020 Dosage and Administration, Screen for Bipolar • Activation of Mania/Hypomania: Screen patients for bipolar Disorder Prior to Starting TRINTELLIX (2.2) 1/2021 disorder (5.4). Dosage and Administration, Use of TRINTELLIX with Other • Angle Closure Glaucoma: Angle closure glaucoma has occurred MAOIs Such as Linezolid or Methylene Blue (2.5) Removed 1/2021 in patients with untreated anatomically narrow angles treated with Warnings and Precautions, Suicidal Thoughts and antidepressants (5.6). Behaviors in Adolescents and Young Adults (5.1) 1/2021 • Warnings and Precautions, Increased Risk of Bleeding (5.3) 1/2021 Hyponatremia: Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.7). Warnings and Precautions, Discontinuation Syndrome (5.5) 1/2021 ----------------------------INDICATIONS AND USAGE--------------------------­ ------------------------------ADVERSE REACTIONS------------------------------­ TRINTELLIX is indicated for the treatment of major depressive disorder Most common adverse reactions (incidence ≥5% and at least twice the (MDD) in adults (1, 14). rate of placebo) were: nausea, constipation and vomiting (6). ----------------------DOSAGE AND ADMINISTRATION------------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Takeda • The recommended starting dose is 10 mg administered orally Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825­ once daily without regard to meals (2.1). 3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. • The dose should then be increased to 20 mg/day, as tolerated ------------------------------DRUG INTERACTIONS------------------------------­ (2.1). • Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered (2.5, 7.1). • Consider 5 mg/day for patients who do not tolerate higher doses (2.1). • Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum • TRINTELLIX can be discontinued abruptly. However, it is recommended dose should not exceed 3 times the original dose recommended that doses of 15 mg/day or 20 mg/day be reduced (2.6, 7.1). to 10 mg/day for one week prior to full discontinuation if possible (2.3). -----------------------USE IN SPECIFIC POPULATIONS-----------------------­ • The maximum recommended dose is 10 mg/day in known Pregnancy: Third trimester use may increase risk for persistent CYP2D6 poor metabolizers (2.5). pulmonary hypertension and withdrawal in the newborn (8.1). ---------------------DOSAGE FORMS AND STRENGTHS---------------------­ Tablets: 5 mg, 10 mg and 20 mg (3). See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 1/2021 _________________________________________________________________________________________________________________________ Reference ID: 4735442 Page 2 of 32 FULL PRESCRIBING INFORMATION: CONTENTS* 7 DRUG INTERACTIONS WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 7.1 Drugs Having Clinically Important Interactions with TRINTELLIX 1 INDICATIONS AND USAGE 7.2 Effect of TRINTELLIX on Other Drugs 2 DOSAGE AND ADMINISTRATION 7.3 Interference with Urine Enzyme Immunoassays for 2.1 Recommended Dosage Methadone 2.2 Screen for Bipolar Disorder Prior to Starting TRINTELLIX 8 USE IN SPECIFIC POPULATIONS 2.3 Discontinuing Treatment 8.1 Pregnancy 2.4 Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders 8.2 Lactation 2.5 Use of TRINTELLIX in Known CYP2D6 Poor Metabolizers or 8.4 Pediatric Use in Patients Taking Strong CYP2D6 Inhibitors 8.5 Geriatric Use 2.6 Use of TRINTELLIX in Patients Taking Strong CYP Inducers 8.6 CYP2D6 Poor Metabolizers 3 DOSAGE FORMS AND STRENGTHS 10 OVERDOSAGE 4 CONTRAINDICATIONS 10.1 Human Experience 5 WARNINGS AND PRECAUTIONS 10.2 Management of Overdose 5.1 Suicidal Thoughts and Behaviors in Adolescents and Young 11 DESCRIPTION Adults 12 CLINICAL PHARMACOLOGY 5.2 Serotonin Syndrome 12.1 Mechanism of Action 5.3 Increased Risk Of Bleeding 12.2 Pharmacodynamics 5.4 Activation of Mania/Hypomania 12.3 Pharmacokinetics 5.5 Discontinuation Syndrome 13 NONCLINICAL TOXICOLOGY 5.6 Angle Closure Glaucoma 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5.7 Hyponatremia 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 6.1 Clinical Studies Experience 17 PATIENT COUNSELING INFORMATION 6.2 Postmarketing Experience * Sections or subsections omitted from the full prescribing information are not listed. _________________________________________________________________________________________________________________________ Reference ID: 4735442 Page 3 of 32 FULL PRESCRIBING INFORMATION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. TRINTELLIX is not approved for use in pediatric patients [see Use in Specific Populations (8.4)]. 1 INDICATIONS AND USAGE TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended starting dose is 10 mg administered orally once daily without regard to meals. Dosage should then be increased to 20 mg/day, as tolerated. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses [see Clinical Studies (14)]. 2.2 Screen for Bipolar Disorder Prior to Starting TRINTELLIX Prior to initiating treatment with TRINTELLIX or another antidepressant, screen patients for personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.4)]. 2.3 Discontinuing Treatment Although TRINTELLIX can be abruptly discontinued, in placebo-controlled trials patients experienced transient adverse reactions such as headache and muscle tension following abrupt discontinuation of TRINTELLIX 15 mg/day or 20 mg/day. It is recommended that the dose be decreased to 10 mg/day for one week before full discontinuation of TRINTELLIX 15 mg/day or 20 mg/day [see Warnings and Precautions (5.5) and Adverse Reactions (6)]. 2.4 Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days must elapse between discontinuation of a MAOI intended to treat psychiatric disorders and initiation of therapy with TRINTELLIX to avoid the risk of Serotonin Syndrome [see Warnings and Precautions (5.2)]. Conversely, at least 21 days must elapse after stopping TRINTELLIX before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4)]. 2.5 Use of TRINTELLIX in Known CYP2D6 Poor Metabolizers or in Patients Taking Strong CYP2D6 Inhibitors The maximum recommended dose of TRINTELLIX is 10 mg/day in known CYP2D6 poor metabolizers. Reduce the dose of TRINTELLIX by one-half when patients are receiving a CYP2D6 strong inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) concomitantly. The dose should be increased to the original level when the Reference ID: 4735442 Page 4 of 32 CYP2D6 inhibitor is discontinued [see Drug Interactions (7.1), Use in Specific Populations (8.6)]. 2.6 Use of TRINTELLIX in Patients Taking Strong CYP Inducers Consider increasing the dose of TRINTELLIX when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for greater than 14 days. The maximum recommended dose should not exceed three times
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