VIIBRYD Tablet (2020)

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Allergan, Inc.

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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening ...

1. Indications and Usage

VIIBRYD is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].

2. Dosage and Administration

Dosage for Treatment of Major Depressive Disorder The recommended target dosage for VIIBRYD is 20 mg to 40 mg orally once daily with food [see Clinical Pharmacology (12.3), Clinical Studies (14)]. To achieve ...

3. Dosage Forms and Strengths

VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg film-coated tablets. 10 mg pink, oval tablet, debossed with 10 on one side. 20 mg orange, oval tablet, debossed with 20 on one side. 40 mg blue, ...

4. Contraindications

VIIBRYD is contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behavior 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 labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] ...

6.1. Clinical Trials Experience

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

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VIIBRYD. 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 VIIBRYD Table 4. Clinically Important Drug Interactions with VIIBRYD: Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation ...

8. Use in Specific Populations

8.6 Use in Other Patient Populations No dosage adjustment of VIIBRYD is necessary on the basis of gender, renal function (mild to severe renal impairment, glomerular filtration rate: 15-90 mL/minute), ...

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 are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production. However, vilazodone is excreted ...

8.4. Pediatric Use

The safety and effectiveness of VIIBRYD have not been established in pediatric patients for the treatment of MDD. Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including ...

8.5. Geriatric Use

Based on a pharmacokinetic study, no dosage adjustment of VIIBRYD is recommended on the basis of age (see Figure 3). Results from pharmacokinetic study of a single 20 mg VIIBRYD dose in geriatric subjects ...

9.1. Controlled Substance

VIIBRYD is not a controlled substance.

9.2. Abuse

VIIBRYD has been systematically studied in animals and did not demonstrate abuse or dependence potential. While VIIBRYD has not been systematically studied in humans for its potential for abuse, there ...

10. Overdosage

There is limited clinical trial experience regarding human overdose with VIIBRYD. The adverse reactions associated with overdose of VIIBRYD at doses of 200-280 mg (5 to 7 times the recommended dosage) ...

11. Description

VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl ...

12.1. Mechanism of Action

The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through ...

12.2. Pharmacodynamics

Vilazodone binds with high affinity to the serotonin reuptake site (Ki= 0.1 nM), but not to the norepinephrine (Ki=56 nM) or dopamine (Ki=37 nM) reuptake sites. Vilazodone potently and selectively inhibits ...

12.3. Pharmacokinetics

Vilazodone activity is due primarily to the parent drug. The pharmacokinetics of vilazodone (5 mg 80 mg) are dose-proportional. Accumulation of vilazodone after administration of single VIIBRYD doses ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenicity studies were conducted in which B6C3F1mice and Wistar rats were given oral doses of vilazodone up to 135 and 150 mg/kg/day, respectively, for 2 years. These doses are approximately ...

14. Clinical Studies

The efficacy of VIIBRYD as a treatment for major depressive disorder was demonstrated in four multicenter, randomized, double-blind, placebo-controlled studies in adult (18-70 years of age) outpatients ...

16.1. How Supplied

VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Tablet Strength Tablet Color/Shape Tablet Markings Package Configuration NDC Code 10 mg pink, oval tablet debossed ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early ...