1. Home
  2. Product
  3. Medications: Fetzima® – levomilnacipran

Medications: Fetzima® – levomilnacipran

MEDICATIONS

Fetzima® – levomilnacipran (View the FDA label)

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

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).

Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor patients for clinical worsening and suicidal thinking or behavior (5.1).

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue FETZIMA and initiate supportive treatment. If concomitant use of FETZIMA with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).

Elevated Blood Pressure and Heart Rate: Measure heart rate and blood pressure prior to initiating treatment and periodically throughout treatment. Control pre-existing hypertension before initiating therapy with FETZIMA (5.3, 5.4).

Abnormal Bleeding: Treatment can increase the risk of bleeding. Caution patients about the risk of bleeding associated with the use of NSAIDs, aspirin, or other drugs that affect coagulation (5.5).

Narrow-angle Glaucoma: Mydriasis has occurred with FETZIMA. Use cautiously in patients with Controlled Narrow-angle Glaucoma. Monitor patients with raised intraocular pressure or those at risk (4, 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).

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

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.

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

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

Precautions

Suicidal Thoughts and Behaviors in Adolescents and Young Adults: Monitor patients for clinical worsening and suicidal thinking or behavior (5.1).

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). If such symptoms occur, discontinue FETZIMA and initiate supportive treatment. If concomitant use of FETZIMA with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5.2).

Elevated Blood Pressure and Heart Rate: Measure heart rate and blood pressure prior to initiating treatment and periodically throughout treatment. Control pre-existing hypertension before initiating therapy with FETZIMA (5.3, 5.4).

Abnormal Bleeding: Treatment can increase the risk of bleeding. Caution patients about the risk of bleeding associated with the use of NSAIDs, aspirin, or other drugs that affect coagulation (5.5).

Narrow-angle Glaucoma: Mydriasis has occurred with FETZIMA. Use cautiously in patients with Controlled Narrow-angle Glaucoma. Monitor patients with raised intraocular pressure or those at risk (4, 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

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

Overdose

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.

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.

Interpreting the GeneSight® Test:
Gene-Drug Interaction Chart

Menu