Fetzima

FETZIMA- levomilnacipran hydrochloride capsule, extended release
FETZIMA- levomilnacipran hydrochloride
Allergan, Inc.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 ) ] .

FETZIMA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 ) ] .

1 INDICATIONS AND USAGE

FETZIMA® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14)].

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.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 Screen for Bipolar Disorder Prior to Starting FETZIMA

Prior to initiating treatment with FETZIMA or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.8) ].

2. 3 Special Populations

Renal Impairment: 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 ( 8.7)].

2.4 Discontinuing Treatment

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 ( 5.10)].

2.5 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 ( 4)].

2.6 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 ( 4)].

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 ( 5.2)].

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 ( 5.2)].

2. 7 Use of FETZIMA with Strong Inhibitors of Cytochrome P450 (CYP3A 4 ) Enzyme

The dose of FETZIMA should not exceed 80 mg once daily when used with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ritonavir) [ s ee Drug Interactions ( 7.1)]

3 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 capwhite body black “FL” on capblack “20” on body
40 mg yellow capyellow body black “FL” on capblack “40” on body
80 mg pink capwhite body black “FL” on capblack “80” on body
120 mg pink cappink body black “FL” on capblack “120” on body

4 CONTRAINDICATIONS

  • Hypersensitivity to levomilnacipran, milnacipran HCl or to any excipient in the formulation.
  • The use of MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA is contraindicated because of an increased risk of serotonin syndrome. The use of FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration ( 2.5) and Warnings and Precautions ( 5.2)].

Starting FETZIMA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6) and Warnings and Precautions ( 5.2)].

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