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Desvenlafaxine

DESVENLAFAXINE SUCCINATE

Manufacturer: Alembic Pharmaceuticals Limited

Score: 144.0

Quick Summary

Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, USP, a structurally novel SNRI for the treatment of MDD. It is indicated for the treatment of adults with major depressive disorder (MDD) and has a recommended dose of 50 mg once daily, with or without food. The drug has several important safety considerations, including warnings about suicidal thoughts and behaviors, serotonin syndrome, and increased risk of bleeding. Dose adjustments are recommended for patients with renal impairment, hepatic impairment, and other special populations, including pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD)
  • The recommended dose is 50 mg once daily, with or without food
  • Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients (7 to 17 years of age) for the treatment of MDD

Important Safety Information

Warning

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies

Contraindications

  • Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine extended-release tablets formulation
  • The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine
  • Starting desvenlafaxine in a patient who is being treated with linezolid or intravenous methylene blue

Adverse Reactions

  • Nausea
  • Dizziness
  • Insomnia
  • Hyperhidrosis
  • Constipation
  • Somnolence
  • Decreased appetite
  • Anxiety
  • Specific male sexual function disorders

Dosing Recommendations

General Guidance

Dose adjustments are recommended for patients with renal impairment, hepatic impairment, and other special populations

Major depressive disorder (MDD)

Adult Dose

50 mg once daily, with or without food

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy
  • Exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage

Nursing Mothers

  • The drug is excreted in human milk

Pediatric Use

  • The safety and effectiveness of desvenlafaxine have not been established in pediatric patients for the treatment of MDD
  • Efficacy was not demonstrated in two adequate and well controlled, 8-week, randomized, double-blind, placebo-controlled, parallel group studies conducted in 587 patients (7 to 17 years of age) for the treatment of MDD

Geriatric Use

  • Of the 4,158 patients in pre-marketing clinical studies with desvenlafaxine, 6% were 65 years of age or older
  • No overall differences in safety or efficacy were observed between these patients and younger patients

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