"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...
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-IVTR) 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.
DOSAGE AND ADMINISTRATION
Initial Treatment Of Major Depressive Disorder
The recommended dose for VIIBRYD is 40 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].
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.
Concomitant Use Of CYP3A4 Inhibitors Or CYP3A4 Inducers
Patients receiving concomitant CYP3A4 inhibitors
Reduce the VIIBRYD dose to 20 mg if co-administered with a strong inhibitor of CYP3A4 (e.g., ketoconazole). During coadministration with moderate inhibitors of CYP3A4 (e.g., erythromycin), the VIIBRYD dose should be reduced to 20 mg for patients with intolerable adverse events. The VIIBRYD dose should be readjusted to the original level when CYP3A4 inhibitors are discontinued [see DRUG INTERACTIONS].
Patients receiving concomitant CYP3A4 inducers
Based on clinical response, consider increasing the dose of VIIBRYD up to 2-fold when concomitantly used with strong CYP3A4 inducers (e.g., carbamazepine) for greater than 14 days. The maximum daily dose should not exceed 80 mg. If CYP3A4 inducers are discontinued, reduce the VIIBRYD dose to the original level in 14 days [see DRUG INTERACTIONS].
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
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].
Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045, USA. Licensed from Merck KGaA, Darmstadt, Germany. Revised: July 2014
Last reviewed on RxList: 8/11/2014
This monograph has been modified to include the generic and brand name in many instances.
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