Indications for FETZIMA:
Major depressive disorder (MDD).
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.
Suicidal thoughts and behaviors.
Increased risk of suicidal thoughts and behavior in children and young adults; monitor for clinical worsening and unusual changes. Suicidal ideation. Screen for bipolar disorder. Monitor for serotonin syndrome; discontinue if occurs. Pre-existing hypertension, cardio- or cerebrovascular disease, or tachyarrhythmias. Monitor BP, HR prior to and during therapy; consider discontinuation or other treatment if elevation persists. Risk of bleeding. Angle-closure glaucoma. Obstructive urinary disorders. History of mania/hypomania. Seizure disorder. Renal impairment. Volume depleted. Hyponatremia (esp. elderly); discontinue if symptomatic. Avoid abrupt cessation. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy: see full labeling for effects on neonates in 3rd trimester. Nursing mothers: monitor infants.
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 strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir); see Adults. 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 (consider discontinuing if occurs).
Caps 20mg—30; 40mg, 80mg, 120mg—30, 90; Titration Pack—1 (2 x 20mg + 26 x 40mg)