Generic Name and Formulations:
Levomilnacipran 20mg, 40mg, 80mg, 120mg; ext-rel caps.
Indications for FETZIMA:
Treatment of major depressive disorder.
Limitations Of use:
Not approved for the management of fibromyalgia; efficacy and safety have not been established.
Swallow whole. Initially 20mg once daily for 2 days, and then increase to 40mg once daily; may increase dose in 40mg increments at intervals of ≥2 days; max 120mg once daily. Renal impairment: moderate (CrCl 30–59mL/min): max 80mg once daily; severe (CrCl 15–29mL/min): max 40mg once daily. ESRD: not recommended. Concomitant strong CYP3A4 inhibitors: max 80mg once daily.
<18yrs: not established.
During or within 14 days of MAOIs. Initiating MAOIs during or within 7 days of levomilnacipran. Concomitant linezolid or IV methylene blue.
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor closely for clinical worsening and unusual changes. Monitor for serotonin syndrome; discontinue if occurs. History of bipolar disorder, mania, or hypomania. Pre-existing hypertension, cardio- or cerebrovascular disease, or tachyarrhythmias. Monitor BP, HR; reduce dose or discontinue if elevation persists. Risk of bleeding. Angle-closure glaucoma. Obstructive urinary disorders. Seizure disorder. Renal impairment. Volume depleted. Hyponatremia (esp. elderly); discontinue if symptomatic. Reevaluate periodically. Write ℞ for smallest practical amount. Avoid abrupt cessation. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Contraindications. Allow at least 14 days after MAOI discontinuation before starting levomilnacipran; allow at least 7 days after discontinuing levomilnacipran before starting an MAOI. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Increased risk of bleeding with concomitant NSAIDs, aspirin, warfarin, and others that affect coagulation. Potentiated by concomitant strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir); see Adult. Avoid alcohol. Caution with other CNS-active drugs, or drugs that can increase BP or HR.
Nausea, constipation, vomiting, hyperhidrosis, heart rate increase, erectile dysfunction, tachycardia, palpitations; hypertension, urinary hesitation/retention.
Caps 20mg—30; 40mg, 80mg, 120mg—30, 90; Titration Pack—1 (2 x 20mg + 26 x 40mg)