FETZIMA Dosage & Rx Info | Uses, Side Effects

Fetzima Generic Name & Formulations

Legal Class

General Description

Levomilnacipran 20mg, 40mg, 80mg, 120mg; ext-rel caps.

Pharmacological Class

SNRI.

How Supplied

Caps 20mg—30; 40mg, 80mg, 120mg—30, 90; Titration Pack—1 (2 x 20mg + 26 x 40mg)

Manufacturer

AbbVie

Generic Availability

Mechanism of Action

The exact mechanism of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the CNS, through inhibition of reuptake at serotonin and norepinephrine transporters.

Fetzima Indications

Indications

Major depressive disorder (MDD).

Limitations of Use

Not approved for the management of fibromyalgia; efficacy and safety have not been established.

Fetzima Dosage and Administration

Adult

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.

Children

<18yrs: not established.

Fetzima Contraindications

Contraindications

During or within 14 days of MAOIs. Initiating MAOIs during or within 7 days of levomilnacipran. Concomitant linezolid or IV methylene blue.

Fetzima Boxed Warnings

Boxed Warning

Suicidal thoughts and behaviors.

Fetzima Warnings/Precautions

Warnings/Precautions

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, mania, or hypomania prior to initiation. 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 for bleeding events. Avoid in those with anatomically narrow angles. Obstructive urinary disorders. History of mania/hypomania. Seizure disorder. Renal impairment. Volume depleted. Hyponatremia (esp. elderly). Sexual dysfunction. Avoid abrupt cessation. Reevaluate periodically. Write ℞ for smallest practical amount. Pregnancy: see full labeling for effects on neonates in 3^rd trimester. Nursing mothers: monitor infants.

Fetzima Pharmacokinetics

Absorption

Relative bioavailability: 92%. Median time to peak concentration (T_max): 6–8 hours.

Distribution

Apparent volume of distribution: 387–473 L. Plasma protein bound: 22% over concentration range of 10–1000 ng/mL.

Metabolism

Levomilnacipran undergoes desethylation which is catalyzed primarily by CYP3A4 with minor contribution by CYP2C8, 2C19, 2D6, and 2J2.

Elimination

Renal (58%). Mean apparent total clearance: 21–29 L/h. Half-life: ~12 hours.

Fetzima Interactions

Interactions

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, other SNRIs, SSRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, 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 aspirin, NSAIDs, warfarin, and others that affect coagulation. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, itraconazole, ritonavir); see Adult. Avoid alcohol. Caution with other CNS-active drugs, or drugs that can increase BP or HR.

Fetzima Adverse Reactions

Adverse Reactions

Nausea, constipation, vomiting, hyperhidrosis, heart rate increase, erectile dysfunction, tachycardia, palpitations; hypertension, urinary hesitation/retention (consider discontinuing if occurs).

Fetzima Clinical Trials

See Literature

Fetzima Note

Not Applicable

Fetzima Patient Counseling