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VIIBRYD (vilazodone HCL) tablet

Please see package insert for additional information and possible updates. 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.    [  Read the disclaimer    |   <<Back    |    New drug index   ]
DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED
WARNINGS

WARNINGS  top of page

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of VIIBRYD or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. VIIBRYD is not approved for use in pediatric patients [see Warnings and Precautions , Use in Specific Populations, and package insert for Patient Counseling Information.]

(DESCRIPTION) top of page

Initial U.S. Approval: 2011
DESCRIPTION
VIIBRYD Tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist.

In addition to the active ingredient, VIIBRYD Tablets contain lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only) and FD&C Red #40 (10 mg only).

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY
Mechanism of action
The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT1A receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone's antidepressant effect are unknown.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
VIIBRYD is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, randomized, double-blind, placebo-controlled trials in adult patients with a diagnosis of MDD.

Major depressive disorder consists of one or more major depressive episodes. A major depressive episode (DSM-IV-TR) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation.

DRUG INTERACTIONS
MAOIs: Do not use VIIBRYD concomitantly with an MAOI or within 14 days of stopping or starting an MAOI.

CYP3A4 inhibitors: The VIIBRYD dose should be reduced to 20 mg when co-administered with CYP3A4 strong inhibitors.

CYP3A4 inducers: Concomitant use of VIIBRYD with inducers of CYP3A4 can result in inadequate drug concentrations and may diminish effectiveness. The effect of CYP3A4 inducers on systemic exposure of vilazodone has not been evaluated.


USE IN SPECIFIC POPULATIONS
Pregnancy: There are no controlled human data regarding VIIBRYD use during pregnancy. Use only if the potential benefits outweigh the potential risks.

Nursing Mothers: There are no human data regarding VIIBRYD concentrations in breast milk. Women should breast feed only if the potential benefits outweigh the potential risks.

Pediatric Use: The safety and efficacy of VIIBRYD in pediatric patients have not been studied.

Geriatric Use: No dose adjustment is recommended on the basis of age.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. VIIBRYD has not been studied in patients with severe hepatic impairment.

Renal Impairment: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment.

CONTRAINDICATIONS top of page

Monoamine Oxidase Inhibitors: Do not use VIIBRYD concomitantly with an MAOI or within 14 days of stopping or starting an MAOI

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS
Clinical Worsening/Suicide Risk: Monitor patients for clinical worsening and suicidal thinking or behavior.

Serotonin Syndrome or Neuroleptic Malignant (NMS)-like Syndrome: Can occur with treatment. Discontinue and initiate supportive treatment.

Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder.

Abnormal Bleeding: Treatment can increase the risk of bleeding. Use with caution in association with nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation.

Activation of Mania/Hypomania: Can occur with treatment. Screen patients for bipolar disorder.

Discontinuation of Treatment with VIIBRYD: A gradual reduction in dose is recommended rather than an abrupt cessation.

Hyponatremia: Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

ADVERSE REACTIONS top of page

The most common adverse reactions (incidence geq 5% and at least twice the rate of placebo) are: diarrhea, nausea, vomiting, and insomnia.

To report SUSPECTED ADVERSE REACTIONS, contact Forest Laboratories, Inc. at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION  top of page

SUMMARY:
The recommended dose for VIIBRYD is 40 mg once daily.
VIIBRYD should be titrated to the 40 mg dose, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily.
VIIBRYD should be taken with food. Administration without food can result in inadequate drug concentrations and may diminish effectiveness.
When discontinuing treatment, reduce the dose gradually.
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DOSAGE AND ADMINISTRATION

Initial Treatment of Major Depressive Disorder
The recommended dose for VIIBRYD is 40 mg once daily. VIIBRYD should be titrated, starting with an initial dose of 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then an increase to 40 mg once daily. VIIBRYD should be taken with food. VIIBRYD blood concentrations (AUC) in the fasted state can be decreased by approximately 50% compared to the fed state, and may result in diminished effectiveness in some patients.


Maintenance/Continuation/Extended Treatment
The efficacy of VIIBRYD has not been systematically studied beyond 8 weeks. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.


Dosing in Special Populations
Pregnant Women: Neonates exposed to serotonergic antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with VIIBRYD, consider whether the potential benefits outweigh the potential risks of treatment.

Nursing Mothers: There are no clinical data regarding the effect of VIIBRYD on lactation and nursing. Breastfeeding in women treated with VIIBRYD should be considered only if the potential benefit outweighs the potential risk.

Pediatric Patients: The safety and efficacy of VIIBRYD have not been studied in pediatric patients.

Geriatric Patients: No dose adjustment is recommended on the basis of age.

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. VIIBRYD has not been studied in severe hepatic impairment.

Renal Impairment: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment.

Gender: No dose adjustment is recommended on the basis of gender.


Discontinuing Treatment
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.


Monoamine Oxidase Inhibitors (MAOI)
At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with VIIBRYD. In addition, at least 14 days must be allowed after stopping VIIBRYD before starting an MAOI.

HOW SUPPLIED top of page

DOSAGE FORMS AND STRENGTHS
VIIBRYD Tablets are available as 10 mg, 20 mg and 40 mg immediate-release, 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, oval tablet, debossed with 40 on one side

REFERENCE

Package Insert data: 
Distributed by
Forest Pharmaceuticals, Inc.
Subsidiary of Forest Laboratories, Inc.
St. Louis, MO 63045, USA

Licensed from Merck KGaA,
Darmstadt, Germany

VIIBRYD™ is a trademark of Forest Laboratories, Inc.
© 2011 Forest Laboratories, Inc.
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