BETHESDA, MD 29 July 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
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), levomilnacipran was found in clinical trials to
significantly improve symptoms of major depression in adults when compared with
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
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.