Indicated for the treatment of Major Depressive Disorder (MDD) in adults.

FETZIMA is not approved for use in pediatric patients.

FETZIMA is not approved for the management of fibromyalgia.

FETZIMA is not approved for use in treating bipolar depression.

Prior to initiating treatment with FETZIMA or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

FETZIMA is not recommended for patients with end stage renal disease.

For patients with moderate renal impairment (creatinine clearance of 30-59 mL/min), the maintenance dose should not exceed 80 mg once daily.

For patients with severe renal impairment (creatinine clearance of 15-29 mL/min), the maintenance dose should not exceed 40 mg once daily.

Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as FETZIMA. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible.

SNRIs, including FETZIMA, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Pre-existing hypertension should be controlled before initiating treatment with FETZIMA.

SNRIs including FETZIMA have been associated with increased heart rate. Heart rate should be measured prior to initiating treatment and periodically throughout FETZIMA treatment. Preexisting tachyarrhythmias and other cardiac disease should be treated before starting therapy with FETZIMA.

The pupillary dilation that occurs following use of many antidepressant drugs including FETZIMA may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

The noradrenergic effect of SNRIs including FETZIMA, can affect urethral resistance. Caution is advised in the use of FETZIMA in patients prone to obstructive urinary disorders.

FETZIMA should be prescribed with caution in patients with a seizure disorder.

SSRIs and SNRIs, including FETZIMA, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin, and other anticoagulants may add to this risk.

Symptoms of mania/hypomania were reported in 0.2% of FETZIMA-treated patients and 0.2% of placebo-treated patients in clinical studies. Activation of mania/hypomania has also been reported in a small proportion of patients with mood disorders who were treated with other antidepressants. As with all antidepressants, use FETZIMA cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including FETZIMA. In many cases, hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted can be at greater risk. FETZIMA should be discontinued in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Do not use MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA. Do not use FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start FETZIMA in a patient who is being treated with linezolid or intravenous methylene blue.

Use of SNRIs, including Fetzima, may cause symptoms of sexual dysfunction. In male patients, SNRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SNRI use may result in decreased libido and delayed or absent orgasm.

Selective-serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), including FETZIMA, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs. Serotonin syndrome can also occur when these drugs are used alone.

Concomitant use of FETZIMA and alcohol may result in accelerated release of levomilnacipran. Avoid concomitant use of FETZIMA and alcohol.

The dose of FETZIMA should not exceed 80 mg once daily when used with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ritonavir).

Dose adjustment is recommended when FETZIMA is co-administered with strong inhibitors of CYP3A4 (e.g. ketoconazole).

There are no adequate and well-controlled studies of FETZIMA in pregnant women. Neonates exposed to dual reuptake inhibitors of serotonin and norepinephrine (such as FETZIMA), or selective serotonin reuptake inhibitors late in the third trimester have developed complications that can arise immediately upon delivery.

It is not known if FETZIMA is present in human milk. Studies have shown that levomilnacipran is present in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from FETZIMA, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under the age of 18. GoToSource

• Fibromyalgia. GoToSource 

• Dosage greater than 120 mg per day in patients without renal impairment. GoToSource 

• Fatigue and ischaemic stroke recovery. GoToSource

Constipation, tachycardia, urinary hesitation, hyperhidrosis (excessive sweating), insomnia, hypertension (high blood pressure) and ejaculation disorder. GoToSource

Palpitations and orthostatic hypotension (fall in blood pressure after standing). GoToSource

Suicidal ideation and behavior. GoToSource

Gastrointestinal symptoms (nausea, diarrhea, gastric bleeding, dyspepsia), liver injury, weight gain, QT interval prolongation, hyponatremia (low blood sodium level), osteoporosis and risk of fractures, bleeding, lowering of seizure threshold, movement disorders, affective disturbances (apathy), ophthalmic manifestations (glaucoma, cataract), hyperprolactinemia (high levels of prolactin in the blood) and discontinuation syndromes. GoToSource

Serotonin syndrome (potentially life-threatening drug reaction). GoToSource

Lawsuits filed for birth defects.