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  5. Medications: Fetzima® – levomilnacipran

Medications: Fetzima® – levomilnacipran

MEDICATIONS

Fetzima® – levomilnacipran (View the FDA label)

INDICATION AND USES:

FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults (1).

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 (1).

DOSAGE AND ADMINISTRATION

  • Recommended dose: 40 mg to 120 mg once daily with or without food (2.1).
  • Initiate dose at 20 mg once daily for 2 days and then increase to 40 mg once daily (2.1).
  • Based on efficacy and tolerability, increase dose in increments of 40 mg at intervals of 2 or more days (2.1).
  • The maximum recommended dose is 120 mg once daily (2.1).
  • Take capsules whole; do not open, chew or crush (2.1)
  • Renal Impairment: Do not exceed 80 mg once daily for moderate impairment. Do not exceed 40 mg once daily for severe renal impairment (2.3).
  • Discontinuation: Reduce dose gradually whenever possible (2.4)

SIDE EFFECTS:

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) are: nausea, constipation, hyperhidrosis, heart rate increase, erectile dysfunction, tachycardia, vomiting, and palpitations (6.1).

CONTRAINDICATIONS:

  • Hypersensitivity to levomilnacipran, milnacipran HCl, or any excipient in the FETZIMA formulation (4)
  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA. Do not use FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start FETZIMA in a patient who is being treated with linezolid or intravenous methylene blue (4).

WARNINGS AND PRECAUTIONS:

  • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue FETZIMA and initiate supportive treatment (5.2).
  • Elevated Blood Pressure and Heart Rate: Control hypertension before initiating therapy with FETZIMA. Monitor blood pressure regularly during treatment (5.3, 5.4).
  • Increased Risk of Bleeding: Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.5).
  • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.6).
  • Urinary Hesitation or Retention: Can occur. If such symptoms occur, discontinue FETZIMA or consider other appropriate medical intervention (5.7).
  • Activation of Mania/Hypomania: Screen patients for bipolar disorder, Caution patients about risk of activation of mania/hypomania (5.8).
  • Seizures: Can occur. Use with caution in patients with a seizure disorder (5.9).
  • Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.10).
  • Hyponatremia: Can occur in association with SIADH (5.11).

DRUG INTERACTIONS:

Strong CYP3A4 inhibitors such as ketoconazole: Do not exceed 80 mg once daily (7)

OVERDOSE:

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.

Management of Overdose: No specific antidotes for FETZIMA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice. The high volume of distribution of levomilnacipran suggests that dialysis will not be effective in reducing levomilnacipran plasma concentrations.

Uses

INDICATION AND USES:

FETZIMA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults (1).

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 (1).

DOSAGE AND ADMINISTRATION

  • Recommended dose: 40 mg to 120 mg once daily with or without food (2.1).
  • Initiate dose at 20 mg once daily for 2 days and then increase to 40 mg once daily (2.1).
  • Based on efficacy and tolerability, increase dose in increments of 40 mg at intervals of 2 or more days (2.1).
  • The maximum recommended dose is 120 mg once daily (2.1).
  • Take capsules whole; do not open, chew or crush (2.1)
  • Renal Impairment: Do not exceed 80 mg once daily for moderate impairment. Do not exceed 40 mg once daily for severe renal impairment (2.3).
  • Discontinuation: Reduce dose gradually whenever possible (2.4)
Side Effects

SIDE EFFECTS:

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) are: nausea, constipation, hyperhidrosis, heart rate increase, erectile dysfunction, tachycardia, vomiting, and palpitations (6.1).

Precautions

CONTRAINDICATIONS:

  • Hypersensitivity to levomilnacipran, milnacipran HCl, or any excipient in the FETZIMA formulation (4)
  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with FETZIMA or within 7 days of stopping treatment with FETZIMA. Do not use FETZIMA within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start FETZIMA in a patient who is being treated with linezolid or intravenous methylene blue (4).

WARNINGS AND PRECAUTIONS:

  • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue FETZIMA and initiate supportive treatment (5.2).
  • Elevated Blood Pressure and Heart Rate: Control hypertension before initiating therapy with FETZIMA. Monitor blood pressure regularly during treatment (5.3, 5.4).
  • Increased Risk of Bleeding: Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.5).
  • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants (5.6).
  • Urinary Hesitation or Retention: Can occur. If such symptoms occur, discontinue FETZIMA or consider other appropriate medical intervention (5.7).
  • Activation of Mania/Hypomania: Screen patients for bipolar disorder, Caution patients about risk of activation of mania/hypomania (5.8).
  • Seizures: Can occur. Use with caution in patients with a seizure disorder (5.9).
  • Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.10).
  • Hyponatremia: Can occur in association with SIADH (5.11).
Interactions

DRUG INTERACTIONS:

Strong CYP3A4 inhibitors such as ketoconazole: Do not exceed 80 mg once daily (7)

Overdose

OVERDOSE:

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.

Management of Overdose: No specific antidotes for FETZIMA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. In case of an overdose, consult a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice. The high volume of distribution of levomilnacipran suggests that dialysis will not be effective in reducing levomilnacipran plasma concentrations.

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