FETZIMA Extended release capsule (2019)

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Allergan, Inc.

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BOXED WARNING SECTION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increas ed the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Clos ely monitor all ...

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. ...

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 ...

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 cap white 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 ...

5. Warnings and Precautions

5.1 Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately ...

6. Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4)] Suicidal Thoughts and Behaviors in Adolescents and ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another ...

6.2. Postmarketing Experience

The following adverse reaction has been identified during post-approval use of FETZIMA or other selective serotonin and norepinephrine reuptake inhibitors. Because these reactions are reported voluntarily ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with FETZIMA Table 5 includes clinically important drug interactions with FETZIMA. Table 5. Clinically Important Drug Interactions with FETZIMA: ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register ...

8.2. Lactation

Risk Summary There are no available data on the presence of levomilnacipran in human milk; however, racemic milnacipran is present in human milk (see Data). There are no reports on the effects ...

8.4. Pediatric Use

Clinical studies on the use of FETZIMA in pediatric patients have not been conducted; therefore, the safety and effectiveness of FETZIMA in the pediatric population have not been established. FETZIMA is ...

8.5. Geriatric Use

No dose adjustment is recommended on the basis of age (see Figure 2). In a multiple-dose clinical pharmacokinetic study, elderly subjects (>65 years) had a slightly higher exposure (Cmax by ...

8.6. Hepatic Impairment

Hepatic elimination of levomilnacipran is low. Dose adjustment is not recommended in subjects with mild (Child-Pugh score of 1-6), moderate (Child-Pugh score of 7-9), or severe (Child-Pugh score of 10-13) ...

8.7. Renal Impairment

Renal excretion plays a predominant role in the elimination of levomilnacipran. Dose adjustment is not recommended for patients with mild (creatinine clearance of 60-89 ml/min) renal impairment. Dosing ...

9.1. Controlled Substance

FETZIMA is not a controlled substance.

9.2. Abuse

FETZIMA has not been systematically studied in animals or humans for its potential for abuse. There was no evidence suggestive of drug-seeking behavior in the clinical studies. It is not possible to predict ...

9.3. Dependence

FETZIMA has not been systematically studied in animals or humans for its potential for dependence.

10. Overdosage

10.1 Human Experience There is limited clinical experience with FETZIMA overdose in humans. In clinical studies, cases of ingestions up to 360 mg daily were reported with none being fatal. 10.2 Management ...

11. Description

Fetzima contains levomilnacipran hydrochloride, a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of levomilnacipran hydrochloride is (1S,2R)2(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide ...

12.1. Mechanism of Action

The exact mechanism of the antidepressant action of levomilnacipran is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition ...

12.2. Pharmacodynamics

Levomilnacipran binds with high affinity to the human serotonin (5-HT) and norepinephrine (NE) transporters (Ki = 11 and 91 nM, respectively) and potently inhibits 5-HT and NE reuptake (IC50 ...

12.3. Pharmacokinetics

The concentration of levomilnacipran at steady state is proportional to dose when administered from 25 to 300 mg once daily. Following an oral administration, the mean apparent total clearance of levomilnacipran ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Levomilnacipran administered by oral gavage to rats for 2 years and Tg.rasH2 mice for 6 months did not increase the incidence of tumors in either study. Rats received levomilnacipran at ...

14. Clinical Studies

14.1 Treatment of Major Depressive Disorder The efficacy of FETZIMA for the treatment of major depressive disorder (MDD) was established in three 8-week randomized, double-blind, placebo-controlled studies ...

16.1. How Supplied

FETZIMA extended-release capsules are supplied in the following configurations: Capsule Strengt Capsule Color/Shape Capsule Markings Package Configuration NDC Code 20 mg yellow cap ...

16.2. 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].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicide Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, ...