Viibryd Dosage

Initial Treatment of Major Depressive Disorder

The recommended dose for VIIBRYD is 40 mg once daily. VIIBRYD should be titrated, 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 an increase to 40 mg once daily. VIIBRYD should be taken with food. VIIBRYD blood concentrations (AUC) in the fasted state can be decreased by approximately 50% compared to the fed state, and may result in diminished effectiveness in some patients [see Clinical Pharmacology (12.3)].

Maintenance/Continuation/Extended Treatment

The efficacy of VIIBRYD has not been systematically studied beyond 8 weeks. It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment.

Dosing in Special Populations

Pregnant Women: Neonates exposed to serotonergic antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. When treating pregnant women with VIIBRYD, consider whether the potential benefits outweigh the potential risks of treatment [see Use in Specific Populations (8.1)].

Nursing Mothers: There are no clinical data regarding the effect of VIIBRYD on lactation and nursing [see Use in Specific Populations (8.3)]. Breastfeeding in women treated with VIIBRYD should be considered only if the potential benefit outweighs the potential risk.

Pediatric Patients: The safety and efficacy of VIIBRYD have not been studied in pediatric patients [see Use in Specific Populations (8.4)].

Geriatric Patients: No dose adjustment is recommended on the basis of age [see Use in Specific Populations (8.5)].

Hepatic Impairment: No dose adjustment is recommended in patients with mild or moderate hepatic impairment. VIIBRYD has not been studied in severe hepatic impairment [see Use in Specific Populations (8.6)].

Renal Impairment: No dose adjustment is recommended in patients with mild, moderate, or severe renal impairment [see Use in Specific Populations (8.7)].

Gender: No dose adjustment is recommended on the basis of gender [see Use in Specific Populations (8.8)].

Discontinuing Treatment

Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate [see Warnings and Precautions (5.6)].

Monoamine Oxidase Inhibitors (MAOI)

At least 14 days must elapse between discontinuation of an MAOI and initiation of therapy with VIIBRYD. In addition, at least 14 days must be allowed after stopping VIIBRYD before starting an MAOI [see Contraindications (4.1) and Drug Interactions (7.1)].