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 pediatric and young adult patients in short-term studies.
Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.
VIIBRYD is not approved for use 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 in Adolescents and Young Adults: 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: Serotonin and norepinephrine reuptake inhibitors (SNRIs) and selective serotonin reuptake inhibitors (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 added 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: 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. Before initiating VIIBRYD,
screen patients for any personal or family history of bipolar disorder, mania, or hypomania. 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.