1. Home
  2. Product
  3. Medications: Viibryd ® – vilazodone

Medications: Viibryd ® – vilazodone

MEDICATIONS

Viibryd® – vilazodone (View the FDA label)

VIIBRYD is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, placebo-controlled trials in adult patients with MDD (1, 14).

DOSAGE AND ADMINISTRATION

The recommended dose for VIIBRYD is 40 mg once daily (2.1).

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 (2.1).

VIIBRYD should be taken with food. Administration without food can result in inadequate drug concentrations and may diminish effectiveness (2.1, 12.3).

When discontinuing treatment, reduce the dose gradually (2.4).

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) are: diarrhea, nausea, vomiting, and insomnia (6).

Clinical Worsening/Suicide Risk:
Monitor patients for clinical worsening and suicidal thinking or behavior (5.1).

Serotonin Syndrome:
Serotonin syndrome has been reported with SSRIs and SNRIs, including VIIBRYD, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, trytophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).

Seizures:
Can occur with treatment. Use with caution in patients with a seizure disorder (5.3).

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 (5.4).

Activation of Mania/Hypomania:
Can occur with treatment. Screen patients for bipolar disorder (5.5).

Discontinuation of Treatment with VIIBRYD:
A gradual reduction in dose is recommended rather than an abrupt cessation (5.6).

Hyponatremia:
Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.7).

MAOIs: Do not use VIIBRYD concomitantly with an MAOI or within 14 days of stopping or starting an MAOI (4.1, 7.2).

CYP3A4 inhibitors: The VIIBRYD dose should be reduced to 20 mg when co-administered with CYP3A4 strong inhibitors (7.5).

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 (7.5).

Human Experience
There is limited clinical experience regarding human overdosage with VIIBRYD. Four patients and 1 patient’s child experienced an overdose of VIIBRYD; all recovered. The adverse reactions associated with overdose of VIIBRYD at doses of 200-280 mg as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation.

Management of Overdose
Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference® (PDR). No specific antidotes for vilazodone are known. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be considered. Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.

Uses

VIIBRYD is indicated for the treatment of major depressive disorder (MDD). The efficacy of VIIBRYD was established in two 8-week, placebo-controlled trials in adult patients with MDD (1, 14).

DOSAGE AND ADMINISTRATION

The recommended dose for VIIBRYD is 40 mg once daily (2.1).

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 (2.1).

VIIBRYD should be taken with food. Administration without food can result in inadequate drug concentrations and may diminish effectiveness (2.1, 12.3).

When discontinuing treatment, reduce the dose gradually (2.4).

Side Effects

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) are: diarrhea, nausea, vomiting, and insomnia (6).

Precautions

Clinical Worsening/Suicide Risk:
Monitor patients for clinical worsening and suicidal thinking or behavior (5.1).

Serotonin Syndrome:
Serotonin syndrome has been reported with SSRIs and SNRIs, including VIIBRYD, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, trytophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue VIIBRYD and initiate supportive treatment. If concomitant use of VIIBRYD with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).

Seizures:
Can occur with treatment. Use with caution in patients with a seizure disorder (5.3).

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 (5.4).

Activation of Mania/Hypomania:
Can occur with treatment. Screen patients for bipolar disorder (5.5).

Discontinuation of Treatment with VIIBRYD:
A gradual reduction in dose is recommended rather than an abrupt cessation (5.6).

Hyponatremia:
Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH) (5.7).

Interactions

MAOIs: Do not use VIIBRYD concomitantly with an MAOI or within 14 days of stopping or starting an MAOI (4.1, 7.2).

CYP3A4 inhibitors: The VIIBRYD dose should be reduced to 20 mg when co-administered with CYP3A4 strong inhibitors (7.5).

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 (7.5).

Overdose

Human Experience
There is limited clinical experience regarding human overdosage with VIIBRYD. Four patients and 1 patient’s child experienced an overdose of VIIBRYD; all recovered. The adverse reactions associated with overdose of VIIBRYD at doses of 200-280 mg as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation.

Management of Overdose
Consult a Certified Poison Control Center for up-to-date guidance and advice. Telephone numbers for certified poison control centers are listed in the Physicians’ Desk Reference® (PDR). No specific antidotes for vilazodone are known. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be considered. Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

Menu