General Information

Fetzima (levomilnacipran) is an extended release selective norepinephrine and serotonin reuptake inhibitor.

Fetzima is specifically indicated for the treatment of Major Depressive Disorder.

Dosing/Administration

Fetzima is supplied as a capsule for oral administration. The recommended dose is 40 mg to 120 mg once daily with or without food. Initiate dose at 20 mg once daily for 2 days and then increase to 40 mg once daily. The dose should be increased in increments of 40 mg at intervals of 2 or more days. The maximum recommended dose is 120 mg once daily. The capsules should be swallowed whole.

Mechanism of Action

Fetzima (levomilnacipran) is an extended release selective norepinephrine and serotonin reuptake inhibitor. The exact mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters. Non-clinical studies have shown that levomilnacipran is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).

Side Effects

Adverse events associated with the use of Fetzima may include, but are not limited to, the following:

nausea

constipation

hyperhidrosis

heart rate increase

erectile dysfunction

tachycardia

vomiting

palpitations

The Fetzima drug label comes with the following Black Box Warning: Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Fetzima is not approved for use in pediatric patients.

Clinical Results

The FDA approval of Fetzima was based on three 8-week randomized, double-blind, placebo-controlled studies (at doses 40120 mg once daily) in adult (18 - 78 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. Two of the studies were fixed dose (Study 1 and Study 2) and one study was flexible dose (Study 3). In Study 1, patients received 40 mg, 80 mg or 120 mg of Fetzima once daily, or placebo. In Study 2, patients received either 40 mg or 80 mg of Fetzima once daily, or placebo. In the flexible-dose study (Study 3), patients received 40 to 120 mg of Fetzima once daily, or placebo. In all three studies, Fetzima demonstrated superiority over placebo in the improvement of depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Fetzima also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale (SDS) functional impairment total score.