Indication and Usage
VIIBRYD (vilazodone HCI) is indicated for the treatment of major depressive disorder (MDD) in adults.
Important Safety Information
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Antidepressants increased the risk of suicidal thoughts and behaviors in patients aged 24
years and younger in short-term studies. Monitor closely for clinical worsening and for
emergence of suicidal thoughts and behaviors.
The safety and efficacy of VIIBRYD have not been established in pediatric patients.
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 risk of serotonin syndrome.
Warnings and Precautions
Suicidal Thoughts and Behavior: Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal
thoughts and behaviors, especially during the initial few months of treatment and when changing
the dose. Counsel family members or caregivers of patients to monitor for changes in behavior
and to alert the healthcare provider. Consider changing the therapeutic regimen, including
possibly discontinuing VIIBRYD, in patients whose depression is persistently worse, or who
are experiencing emergent suicidal thoughts or behaviors.
Serotonin Syndrome: SNRIs and SSRIs, including VIIBRYD, can cause a
potentially life-threatening condition called serotonin syndrome when taken alone, but especially
when used concomitantly with other serotonergic agents (including triptans, tricyclic antidepressants,
fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair
metabolism of serotonin, ie, MAOIs. Symptoms of serotonin syndrome were noted in 0.1% of VIIBRYD-treated
patients in premarketing clinical trials. Serotonin syndrome signs and symptoms may include mental status
changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile
blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity,
myoclonus, hyperreflexia, incoordination), seizures, and gastrointestinal symptoms. Monitor all patients taking
VIIBRYD for the emergence of serotonin syndrome. If symptoms occur, discontinue VIIBRYD and any concomitant
serotonergic agents immediately and initiate supportive treatment. If concomitant use of VIIBRYD with other
serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome.
Increased Risk of Bleeding: Drugs that interfere with serotonin reuptake inhibition, including VIIBRYD, increase the risk of bleeding
events. Inform patients about the risk of bleeding associated with the concomitant use of VIIBRYD and aspirin,
NSAIDs, other antiplatelet drugs, warfarin, or other anticoagulants. For patients taking warfarin, carefully
monitor coagulation indices when initiating, titrating, or discontinuing VIIBRYD.
Activation of Mania/Hypomania: Before initiating VIIBRYD, screen patients for any personal or family history of bipolar disorder,
mania, or hypomania. Treating a depressive episode with VIIBRYD or another antidepressant in a patient
with bipolar disorder may precipitate a mixed/manic episode. In controlled clinical trials, patients with
bipolar disorder were excluded; however, symptoms of mania/hypomania were noted in 0.1% of undiagnosed
patients treated with VIIBRYD. VIIBRYD is not approved for use in treating bipolar depression.
Discontinuation Syndrome: Adverse reactions may occur upon discontinuation of serotonergic antidepressants such as VIIBRYD,
particularly after abrupt discontinuation. Gradual dose reduction is recommended, instead of abrupt
cessation, whenever possible.
Seizures: VIIBRYD should be prescribed with caution in patients with a seizure disorder.
Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressants, including VIIBRYD, may trigger
an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Avoid use of VIIBRYD in patients with untreated anatomically narrow angles.
Hyponatremia: Hyponatremia may occur from treatment with SNRIs and SSRIs, including VIIBRYD. Elderly patients, patients
taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia while
taking VIIBRYD. In patients with symptomatic hyponatremia, discontinue VIIBRYD and institute appropriate
The most commonly observed adverse reactions with VIIBRYD in 8- to 10-week placebo-controlled studies
(incidence ≥5% and at least twice the rate of placebo) by dose (20 mg, 40 mg) vs placebo were: diarrhea
(26%, 29% vs 10%), nausea (22%, 24% vs 7%), insomnia (7%, 6% vs 2%), and vomiting (4%, 5% vs 2%).
Please also see the full Prescribing Information.