Vilazodone

VIIBRYD ® is indicated for the treatment of major depressive disorder (MDD) in adults.

The mechanism of action of vilazodone in the treatment of major depressive disorder is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT 1A receptors, however, the net result of this action on serotonergic transmission and its role in vilazodone’s antidepressant effect are unknown.

Recommended target dosage: 20 mg to 40 mg once daily with food. To titrate: start with initial dosage of 10 mg once daily for 7 days, followed by 20 mg once daily. The dose may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases. Prior to initiating VIIBRYD, screen for bipolar disorder. When discontinuing VIIBRYD, reduce dosage gradually

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. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs

Boxed warning (suicidal thoughts and behaviors): Antidepressants increased the risk of suicidal thoughts and behavi ors 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. V IIBRYD is not approved for use in pediatric patients. Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue VIIBRYD and serotonergic agents and initiate supportive treatment. Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk. Activation of Mania/Hypomania: Screen patients for bipolar disorder. Seizures: Can occur with treatment.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults. Serotonin Syndrome. Increased Risk of Bleeding. Activation of Mania or Hypomania. Discontinuation Syndrome. Seizures. Angle-Closure Glaucoma. Hyponatremia. Sexual Dysfunction. Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia.

CYP3A4 Inhibitors: The VIIBRYD dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors. CYP3A4 Inducers: Consider increasing VIIBRYD dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days.

Store tablets at 25 o C (77°F). Excursions permitted to 15 o C - 30 o C (59°F - 86°F).