individuals differ: Viibryd gives you dosing options

Expand your dosing options with 2 effective dosage strengths

  • The 20 mg therapeutic dose can be reached in 8 days1

Tablets shown are not actual size.

Based on individual patient efficacy and tolerability, the dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases.1

Viibryd® should be taken with food1

  • Taking Viibryd on an empty stomach can reduce plasma concentrations (AUC) by approximately 50% and may diminish effectiveness
  • If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.
  • Prior to initiating treatment with Viibryd, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.
  • Adverse reactions may occur upon discontinuation of Viibryd. Gradual dose reduction rather than abrupt cessation is recommended whenever possible. Viibryd should be tapered from the 40 mg once daily dose to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Patients taking Viibryd 20 mg once daily should be tapered to 10 mg once daily for 7 days.

No dose adjustment is recommended for a range of populations1

  • No dose adjustment necessary based on age or gender1
  • No dose adjustment necessary for patients with renal impairment1
  • No dose adjustment necessary for patients with hepatic impairment1

Drug Interactions

  • The Viibryd dose should not exceed 20 mg once daily if co-administered with strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, voriconazole). The original Viibryd dose level can be resumed when the CYP3A4 inhibitor is discontinued.
  • Based on clinical response, consider increasing Viibryd dose by 2-fold (up to a maximum 80 mg once daily) over 1 to 2 weeks when taking strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin) for greater than 14 days. If CYP3A4 inducers are discontinued, gradually reduce Viibryd dose to original level over 1 to 2 weeks.
  • At least 14 days must elapse between discontinuation of an MAOI antidepressant and initiation of Viibryd. In addition, at least 14 days must elapse after stopping Viibryd before starting an MAOI antidepressant.
  • 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.
  • Concomitant use of Viibryd with NSAIDs, aspirin, warfarin, and other anticoagulants may increase the risk of bleeding events.
  • Concomitant use of Viibryd increased digoxin concentrations. Measure serum digoxin concentrations before initiating concomitant use of Viibryd. Continue monitoring and reduce digoxin dose as necessary.

Use in Specific Populations

  • There are no adequate and well-controlled studies of Viibryd in pregnant women. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.
  • Exposure to SSRIs and SNRIs, including Viibryd, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to Viibryd in the third trimester of pregnancy for PPHN and drug discontinuation syndrome.
  • There are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production. However, vilazodone is excreted in rat milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Viibryd and any potential adverse effects on the breastfed child from Viibryd or from the underlying maternal condition.
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, 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.
  • 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, 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.
  • 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.