These highlights do not include all the information needed to use BRINTELLIX safely and effectively. See full prescribing information for BRINTELLIX.
BRINTELLIX (vortioxetine) tablets, for oral use
Initial U.S. Approval: 2013
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
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Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants (5.1).
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Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1).
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BRINTELLIX has not been eva luated for use in pediatric patients (8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 7/2014
INDICATIONS AND USAGE
BRINTELLIX is indicated for the treatment of major depressive disorder (MDD) (1, 14).
DOSAGE AND ADMINISTRATION
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The recommended starting dose is 10 mg administered orally once daily without regard to meals (2.1).
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The dose should then be increased to 20 mg/day, as tolerated (2.1).
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Consider 5 mg/day for patients who do not tolerate higher doses (2.1).
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BRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible (2.3).
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The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers (2.6).
DOSAGE FORMS AND STRENGTHS
BRINTELLIX is available as 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets (3).
CONTRAINDICATIONS
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Hypersensitivity to vortioxetine or any components of the BRINTELLIX formulation (4).
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Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with BRINTELLIX or within 21 days of stopping treatment with BRINTELLIX. Do not use BRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start BRINTELLIX in a patient who is being treated with linezolid or intravenous methylene b
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