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 [see Clinical Studies].

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.

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 [see CLINICAL PHARMACOLOGY].

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 [see Use In Specific Populations].

Nursing Mothers

There are no clinical data regarding the effect of VIIBRYD on lactation and nursing [see Use In Specific Populations]. 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 [see Use In Specific Populations].

Geriatric Patients

No dose adjustment is recommended on the basis of age [see Use In Specific Populations].

Hepatic Impairment

No dose adjustment is recommended in patients with mild or moderate hepatic impairment. VIIBRYD has not been studied in severe hepatic impairment [see Use In Specific Populations].

Renal Impairment

No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment [see Use In Specific Populations].

Gender

No dose adjustment is recommended on the basis of gender [see Use In Specific Populations].

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 [see WARNINGS AND PRECAUTIONS].

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with VIIBRYD. Conversely, at least 14 days should be allowed after stopping VIIBRYD before starting an MAOI intended to treat psychiatric disorders [see CONTRAINDICATIONS].

Use of VIIBRYD with Other MAOIs such as Linezolid or Methylene Blue

Do not start VIIBRYD in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].

In some cases, a patient already receiving VIIBRYD therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, VIIBRYD should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with VIIBRYD may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with VIIBRYD is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].

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

Storage And Handling

VIIBRYD (vilazodone HCl) Tablets are supplied in the following configurations:

10 mg, pink, oval tablet, debossed with 10 on one side - 0456-1110-30: 30-count bottles

20 mg, orange, oval tablet, debossed with 20 on one side - 0456-1120-30: 30-count bottles

40 mg, blue, oval tablet, debossed with 40 on one side - 0456-1140-30: 30-count bottles

Patient Starter Kit

0456-1100-31: blister card containing 30 tablets:

10 mg, pink, oval, debossed with 10 on one side: 7 tablets
20 mg, orange, oval, debossed with 20 on one side: 7 tablets
40 mg, blue, oval, debossed with 40 on one side: 16 tablets

Storage

VIIBRYD (vilazodone HCl) Tablets should be stored at 25oC (77°F) with excursions permitted to 15oC - 30oC (59°F - 86°F) [see USP Controlled Room Temperature].

Distributed by : Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO 63045, USA. Licensed from Merck KGaA, Darmstadt, Germany. Revised: December 2012

Last reviewed on RxList: 1/10/2013
This monograph has been modified to include the generic and brand name in many instances.