Adult Dosing

Major depressive disorder (MDD)

• Start 20 mg PO Daily x 2days and then increase to 40 mg Daily
• Max recommended dose: 120 mg PO Daily

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Major depressive disorder (MDD)

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to milnacipran
• Uncontrolled narrow-angle glaucoma
• Serotonin Syndrome and Monoamine oxidase inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with levomilnacipran or within 7 days of stopping treatment with levomilnacipran. Do not use levomilnacipran within 14 days of stopping an MAOI intended to treat psychiatric disorders
• Not approved for the management of fibromyalgia

• Antidepressants have increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older
• Closely monitor for worsening, and for emergence of suicidal thoughts and behaviors in all patients who initiate therapy
• Advise families and caregivers of the need for close observation and communication with the precriber
• Not approved for use in pediatric patients

Renal Dose Adjustment

• Mild renal impairment: No dose adjustments
• Moderate impairment: Max dose: 80 mg PO Daily
• Severe impairment: Max dose: 40 mg PO Daily
• End stage renal disease: Use not recommended

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Antidepressants have increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [US black box warning]
• Closely monitor for worsening, and for emergence of suicidal thoughts and behaviors in all patients who initiate therapy. Advise families and caregivers of the need for close observation and communication with the prescriber [US black box warning]
• Not approved for use in pediatric patients [US black box warning]
• Patients with major depressive disorder (MDD), may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs
• All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy
• The following symptoms: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for MDD
• The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, alone but particularly with concomitant use of other serotonergic drugs, including triptoans, tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone and St John's Wort
• Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
• SNRIs, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout. Caution should be exercised in treating patients with pre-existing hypertension, cardiovascular, or cerebrovascular conditions that might be compromised by increases in blood pressure
• SNRIs have been associated with increased heart rate. Heart rate should be measured prior to initiating treatment and periodically throughout. For patients who experience a sustained increase in heart rate while receiving therapy, discontinuation or other appropriate medical intervention should be considered
• Therapy 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. Patients should be cautioned about the risk of bleeding
• Mydriasis has been reported in association with SNRIs. Use cautiously in patients with controlled narrow-angle glaucoma. Patients with raised intraocular pressure or those at risk of acute narrow-angle glaucoma (angle-closure glaucoma) should be monitored
• The noradrenergic effect of SNRIs , can affect urethral resistance
• Use with caution in patients prone to obstructive urinary disorders. If symptoms of urinary hesitation, urinary retention, or dysuria develop during treatment, consideration should be given to the possibility that they might be drug-related, and discontinuation or other appropriate medical intervention should be considered
• Levomilnacipran has not been systematically evaluated in patients with a seizure disorder
• Avoid abrupt discontinuation of therapy. Abrupt discontinuation may lead to sypmtoms such as dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures
• Taper dose when discontinuing if possible, monitoring for discontinuation symptoms
• SSRIs and SNRIs have been associated with hyponatremia

Fetzima interacts with :

	Abstral
	Actiq
	Acular
	Acular LS
	Acuvail
	Advil
	Advil liqui-gels
	Advil migraine liqui-gels
	Aleve
	Alfenta
	Alfentanil
	Anaprox
	Anaprox DS
	Ansaid
	Azilect
	Cambia
	Cataflam
	Children's advil
	Children's advil flavored
	Children's elixsure
	Children's ibuprofen
	Children's motrin
	Clinoril
	Conzip
	Daypro
	Demerol
	Diclofenac
	Diflunisal
	Dolobid
	Dolophine
	Duragesic
	EC-Naprosyn
	Eldepryl
	Emsam
	Etodolac
	Feldene
	Fenoprofen
	Fentanyl
	Fentora
	Flector
	Flurbiprofen
	Furazolidone
	Furoxone
	Ibu-tab
	Ibu-tab 200
	Ibuprofen
	Ibuprohm
	Indocin
	Indomethacin
	Infants' advil
	Infants' motrin
	Isocarboxazid
	Junior strength advil
	Junior strength ibuprofen
	Junior strength motrin
	Ketoprofen
	Ketorolac
	Lazanda
	Linezolid
	Lodine
	Marplan
	Meclofenamate
	Mefenamic acid
	Meloxicam
	Meperidine
	Methadone
	Methadose
	Methblue
	Methylene Blue
	Midol Extended Relief
	Midol liquid gels
	Mobic
	Motrin
	Motrin IB
	Motrin migraine pain
	Nabumetone
	Nalfon
	Naprelan
	Naprosyn
	Naproxen
	Nardil
	Nexcede
	Nucynta
	Nucynta ER
	Ocufen
	Onsolis
	Orudis
	Oxaprozin
	Pamprin All Day
	Parnate
	PediaCare Children's Pain Reliever/ Fever Reducer IB
	PediaCare Infants' Pain Reliever/ Fever Reducer IB
	Pediatric advil
	Pennsaid
	Phenelzine
	Piroxicam
	Ponstel
	Profen
	Rasagiline
	Relafen
	Rybix ODT
	Ryzolt
	Safinamide
	Selegiline
	Solaraze
	Sprix
	Sublimaze
	Subsys
	Sulindac
	Tab-profen
	Tapentadol
	Thiazide Diuretics
	Tivorbex
	Tolectin
	Tolmetin
	Toradol
	Tramadol
	Tranylcypromine
	Ultram
	Ultram ER
	Urolene Blue
	Voltaren
	Voltaren Gel
	Voltaren ophthalmic
	Voltaren-XR
	Westadone
	Xadago
	Zelapar
	Zipsor
	Zorvolex
	Zyvox

Pregnancy Category:C

Breastfeeding: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

• CNS: Migraine, paraesthesia, syncope, extrapyramidal disorder, seizure, mania
• PSYCHIATRY: Migraine; paraesthesia; syncope; extrapyramidal disorder, suicidal thoughts
• GI: Nausea, constipation, vomiting, abdominal pain; flatulence
• EENT: Narrow-angle glaucoma
• CV: Tachycardia, palpitations, hypotension, hypertension, angina pectoris; supraventricular and ventricular extrasystoles
• GU: Erectile dysfunction, testicular pain, ejaculation disorder, urinary hesitation
• METABOLISM: Decreased appetite, hyponatremia
• DERM: Hyperhidrosis, rash, dry skin, pruritus, urticaria
• MISCELLANEOUS: Hot flush, serotonin syndrome
• LAB TESTS: Blood cholesterol increased, liver function test abnormal

• Selective serotonin and norepinephrine reuptake inhibitor (SNRI); exact mechanism of action unknown; potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of reuptake at serotonin and norepinephrine transporters
• Levomilnacipran was the most norepinephrine activity of the SNRI class of antidepressant drugs, based on in in vitro studies
• Bioavailability: 92%
• Metabolism: Primarily metabolised in liver by CYP3A4; undergoes desethylation to form desethyl levomilnacipran and hydroxylation to form p-hydroxy-levomilnacipran
• Excretion: Primarily renal excretion (58% unchanged)

US Trade Name(s)

• Fetzima

US Availability

Fetzima

• ECAPS: 20, 40, 80, 120 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Psychiatric

Antidepressants

SSRIs