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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.

Contraindications

  • 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

  • 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, 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.
  • 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.
  • 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.
  • 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.
  • VIIBRYD should be prescribed with caution in patients with a seizure disorder.
  • 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 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 medical intervention.

Adverse Reactions

  • 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.

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.

Contraindications

  • 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

  • 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, 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.
  • 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.
  • 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.
  • 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.
  • VIIBRYD should be prescribed with caution in patients with a seizure disorder.
  • 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 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 medical intervention.

Adverse Reactions

  • 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.