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Levomilnacipran Approved for Major Depression

Kate Traynor

BETHESDA, MD 29 Jul 2013—Forest Laboratories and Pierre Fabre Laboratories on July 26 announced the approval of levomilnacipran extended-release oral capsules for the treatment of major depressive disorder in adults.

The serotonin- and norepinephrine-reuptake inhibitor (SNRI) will be available during the fourth quarter of this year under the brand name Fetzima, according to the companies.

According to the drug's labeling (PDF)External Link, levomilnacipran was found in clinical trials to significantly improve symptoms of major depression in adults when compared with placebo.

The labeling for levomilnacipran includes a medication guide informing patients that the drug may increase the risk for suicidal thoughts or actions or serotonin syndrome, problems that have been associated with SNRIs and other antidepressants.

Levomilnacipran is not intended for use in pediatric patients or for the treatment of fibromyalgia.

Because of the risk of serotonin syndrome, levomilnacipran is contraindicated for coadministration with any monoamine oxidase inhibitor (MAOI) intended for the treatment of psychiatric symptoms. Levomilnacipran therapy should not be initiated within 14 days after discontinuing an MAOI, and an MAOI should not be initiated within 7 days after discontinuing levomilnacipran.

Coadministration of levomilnacipran and an MAOI such as linezolid or i.v. methylene blue is also contraindicated. The drug must not be used in patients with uncontrolled narrow-angle glaucoma.

Because levomilnacipran may increase the risk of abnormal bleeding, patients should be cautioned about the concomitant use of the drug and other medications, such as nonsteroidal antiinflammatory drugs, that also increase the risk for bleeding.

In clinical trials, the most frequently reported adverse events associated with the use of levomilnacipran were nausea, constipation, vomiting, excessive sweating, increased heart rate, tachycardia, palpitations, and erectile dysfunction.

The recommended dosage range for maintenance therapy with levomilnacipran is 40–120 mg taken once daily with or without food.

Therapy should be initiated at 20 mg taken once daily for 2 days and then increased to 40 mg once daily. The dosage can be increased, on the basis of the patient's response, by increments of 40 mg at intervals of two or more days to a maximum daily dose of 120 mg.

Discontinuation of levomilnacipran should be done through gradual dose tapering, if possible.

Levomilnacipran will be supplied as 20-, 40-, 80-, and 120-mg capsules in bottles of 30 each and in unit dose blister packs of 100 capsules each. All strengths except the 20-mg formulation will also be supplied in bottles of 90 capsules each.

So-called titration packs containing 2 20-mg capsules and 26 40-mg capsules each will also be available. Levomilnacipran should be stored at controlled room temperature.

 

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