"The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mo"...
FETZIMA, a serotonin and norepinephrine reuptake inhibitor (SNRI) is indicated for the treatment of major depressive disorder (MDD). The efficacy of FETZIMA was established in three 8-week, randomized, double-blind, placebo-controlled studies in adult patients with a diagnosis of MDD [see Clinical Studies].
Limitation of Use
FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.
DOSAGE AND ADMINISTRATION
General Instruction for Use
The recommended dose range for FETZIMA is 40 mg to 120 mg once daily, with or without food. FETZIMA should be initiated at 20 mg once daily for 2 days and then increased to 40 mg once daily. Based on efficacy and tolerability, FETZIMA may then be increased in increments of 40 mg at intervals of 2 or more days. The maximum recommended dose is 120 mg once daily.
FETZIMA should be taken at approximately the same time each day. FETZIMA should be swallowed whole. Do not open, chew or crush the capsule.
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacologic therapy. Patients should be reassessed periodically to determine the need for maintenance treatment and the appropriate dose for treatment. The efficacy of FETZIMA has not been established beyond 8 weeks.
Dose adjustment is not recommended in patients with mild renal impairment (creatinine clearance of 60-89 mL/min). 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. FETZIMA is not recommended for patients with end stage renal disease [see Use in Specific Populations].
Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as FETZIMA. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing FETZIMA. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate [see WARNINGS AND PRECAUTIONS].
Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with FETZIMA. Conversely, at least 7 days should be allowed after stopping FETZIMA before starting an MAOI antidepressant [see CONTRAINDICATIONS].
Use of FETZIMA with Other MAOIs such as Linezolid or Methylene Blue
Do not start FETZIMA in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see CONTRAINDICATIONS].
In some cases, a patient already receiving FETZIMA therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, FETZIMA should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with FETZIMA may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see WARNINGS AND PRECAUTIONS].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with FETZIMA is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see WARNINGS AND PRECAUTIONS].
Use of FETZIMA with Strong Inhibitors of Cytochrome P450 (CYP3A4) Enzyme
The dose of FETZIMA should not exceed 80 mg once daily when used with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ritonavir) [see DRUG INTERACTIONS]
Dosage Forms And Strengths
FETZIMA (levomilnacipran) is available as 20 mg, 40 mg, 80 mg and 120 mg extended-release capsules.
|Capsule Strength||Capsule Color/Shape||Capsule Markings|
|20 mg||yellow cap white body||black “FL” on cap black “20” on body|
|40 mg||yellow cap yellow body||black “FL” on cap black “40” on body|
|80 mg||pink cap white body||black “FL” on cap black “80” on body|
|120 mg||pink cap pink body||black “FL” on cap black “120” on body|
FETZIMA extended-release capsules are supplied in the following configurations:
|Capsule Strength||Capsule Color/Shape||Capsule Markings||Package Configuration||NDC Code|
|20 mg||yellow cap white body||black “FL” on cap black “20” on body||Bottle / 30 count||0456-2220-30|
|Hospital Unit Dose (Blister) / 10 x 10||0456-2220-63|
|40 mg||yellow cap yellow body||black “FL” on cap black “40” on body||Bottle / 30 count||0456-2240-30|
|Bottle / 90 count||0456-2240-90|
|Hospital Unit Dose (Blister) / 10 x 10||0456-2240-63|
|80 mg||pink cap white body||black “FL” on cap black “80” on body||Bottle / 30 count||0456-2280-30|
|Bottle / 90 count||0456-2280-90|
|Hospital Unit Dose (Blister) /10 x 10||0456-2280-63|
|120 mg||pink cap pink body||black “FL” on cap black “120” on body||Bottle / 30 count||0456-2212-30|
|Bottle / 90 count||0456-2212-90|
|Hospital Unit Dose (Blister) / 10 x 10||0456-2212-63|
|20 mg||yellow cap white body||black “FL” on cap black “20” on body||Titration Pack (Blister) containing two 20 mg capsules and twenty-six 40 mg capsules||0456-2202-28|
|40 mg||yellow cap yellow body||black “FL” on cap black “40” on body|
Storage and Handling
All package configurations: Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045 USA. Revised: July 2013
Last reviewed on RxList: 8/7/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Fetzima Information
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