VIIBRYD (vilazodone hydrochloride) tablet
Warnings
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(description)
| 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
| 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
| 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 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 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
| Monoamine Oxidase Inhibitors: Do not use VIIBRYD concomitantly with an MAOI or within 14 days of stopping or starting an MAOI |
Precautions
| 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
| The most common adverse reactions (incidence ≥ 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
| 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. --------------- DOSAGE AND ADMINISTRATION Initial Treatment of Major Depressive Disorder Maintenance/Continuation/Extended Treatment Dosing in Special Populations 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 Monoamine Oxidase Inhibitors (MAOI) |
Reference(s)
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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