TRINTELLIX Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Takeda Pharmaceuticals America, Inc.

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BOXED WARNING SECTION

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 ...

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 ...

3. Dosage Forms and Strengths

TRINTELLIX is available as immediate-release, film-coated tablets in the following strengths: 5 mg: pink, almond shaped biconvex film coated tablet, debossed with 5 on one side and TL on the other ...

4. Contraindications

Hypersensitivity to vortioxetine or any component of the formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4)] Clinical Worsening and Suicide Risk [see Warnings ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of TRINTELLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with TRINTELLIX Table 4. Clinically Important Drug Interactions with TRINTELLIX: Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact ...

8. Use in Specific Populations

8.6 CYP2D6 Poor Metabolizers Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers because these patients have higher vortioxetine plasma concentrations than extensive CYP2D6 ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register ...

8.2. Lactation

Risk Summary There is no information regarding the presence of vortioxetine in human milk, the effects on the breastfed infant, or the effects on milk production. Vortioxetine is present in rat milk ...

8.4. Pediatric Use

The safety and effectiveness of TRINTELLIX have not been established in pediatric patients for the treatment of MDD. Efficacy was not established in an 8-week, randomized, double-blind, placebo-controlled, ...

8.5. Geriatric Use

No dose adjustment is recommended on the basis of age (Figure 1). Results from a single-dose pharmacokinetic study in elderly (>65 years old) vs young (24 to 45 years old) subjects demonstrated ...

10. Overdosage

10.1 Human Experience There is limited clinical trial experience regarding human overdosage with TRINTELLIX. In premarketing clinical studies, cases of overdose were limited to patients who accidentally ...

11. Description

TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, ...

12.1. 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 ...

12.2. Pharmacodynamics

Vortioxetine binds with high affinity to the human serotonin transporter (Ki=1.6 nM), but not to the norepinephrine (Ki=113 nM) or dopamine (Ki>1000 nM) transporters. Vortioxetine potently and selectively ...

12.3. Pharmacokinetics

Vortioxetine pharmacological activity is due to the parent drug. The pharmacokinetics of vortioxetine (2.5 mg to 60 mg) are linear and dose-proportional when vortioxetine is administered once daily. The ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenicity studies were conducted in which CD-1 mice and Wistar rats were given oral doses of vortioxetine up to 50 and 100 mg/kg/day for male and female mice, respectively, and 40 ...

14. Clinical Studies

The efficacy of TRINTELLIX in treatment for MDD was established in six, 6 to 8 week randomized, double-blind, placebo-controlled, fixed-dose studies (including one study in the elderly) and one maintenance ...

16.1. How Supplied

TRINTELLIX tablets are available as follows: Features Strengths   5 mg 10 mg 20 mg Color pink yellow red Debossment 5 on one side of tablet 10 on one side of tablet 20 on one side of ...

16.2. Storage and Handling

Store at 77°F (25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].

17. Patient Counseling Information

See FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal ideation and behavior, especially early during ...