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BRINTELLIX®  (vortioxetine) tablets

DESCRIPTION CLINICAL PHARMACOLOGY INDICATIONS AND USAGE
CONTRAINDICATIONS PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED WARNINGS
PRESCRIBING HIGHLIGHTS:  Please see package insert for additional information and possible updates to ensure safe and effective use of this medication. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Please read the disclaimer carefully BEFORE accessing or using this site. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.  
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WARNINGS  top of page

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.

•Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
•Monitor for worsening and emergence of suicidal thoughts and behaviors.
•BRINTELLIX has not been evaluated for use in pediatric patients .

DESCRIPTION  top of page

BRINTELLIX (vortioxetine) tablets, for oral use
Initial U.S. Approval: 2013

BRINTELLIX is an immediate-release tablet for oral administration that contains the beta (ß) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol.

Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water.

Each BRINTELLIX tablet contains 6.355 mg, 12.71 mg, 19.065 mg, or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, 15 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in BRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg, 15 mg, and 20 mg) and iron oxide yellow (10 mg and 15 mg).

CLINICAL PHARMACOLOGY: top of page

Mechanism of Action:
The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine’s antidepressant effect has not been established.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE:
BRINTELLIX is indicated for the treatment of major depressive disorder (MDD)

CONTRAINDICATIONS top of page

Hypersensitivity to vortioxetine or any components of the BRINTELLIX formulation.

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 blue.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS

  1. Serotonin Syndrome has been reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with BRINTELLIX, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue BRINTELLIX and initiate supportive treatment. If concomitant use of BRINTELLIX with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
  2. Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when BRINTELLIX is coadministered with nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation.
  3. Activation of Mania/Hypomania can occur with antidepressant treatment. Screen patients for bipolar disorder.
  4. Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

ADVERSE REACTIONS top of page

ADVERSE REACTIONS
Most common adverse reactions (incidence GEQ5% and at least twice the rate of placebo) were: nausea, constipation and vomiting.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS
>Strong inhibitors of CYP2D6: Reduce BRINTELLIX dose by half when a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) is coadministered.

>Strong CYP Inducers: Consider increasing BRINTELLIX dose when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose.

USE IN SPECIFIC POPULATIONS
> Pregnancy: Based on animal data, BRINTELLIX may cause fetal harm.
>Nursing Mothers: Discontinue BRINTELLIX or nursing.


See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION:

The recommended starting dose is 10 mg administered orally once daily without regard to meals.

The dose should then be increased to 20 mg/day, as tolerated.
Consider 5 mg/day for patients who do not tolerate higher doses.

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.

The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS

BRINTELLIX is available as 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets

REFERENCE

Package insert data:   [Accessed:: Jan 2014]
Distributed and Marketed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

Marketed by:
Lundbeck
Deerfield, IL 60015

BRINTELLIX is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.
©2013 Takeda Pharmaceuticals America, Inc.
LUN205M R1 September 2013
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