Metabolization and CYP Inhibition

Fluvoxamine is extensively metabolized by the liver[1]

  • Metabolized at least in part by CYP450 isoenzyme 2D6
  • The metabolism of fluvoxamine has not been fully characterized
  • The effects of potent CYP450 inhibition has not been studied

Fluvoxamine appears to inhibit several CYP isoenzymes.* This may result in an interaction when fluvoxamine maleate extended-release capsules are prescribed concomitantly with an agent that is metabolized via these isoenzymes[1]

  • Potent inhibitor of CYP1A2; likely a potent inhibitor of CYP3A4
  • Inhibitor of CYP2C9 and CYP2C19
  • Weak inhibitor of CYP2D6

Stronger inhibition may suggest the greater likelihood of an interaction

No drug studied for interactions significantly affected the pharmacokinetics of fluvoxamine

*Classification of inhibition may vary depending on the study.

Please see full prescribing information, including boxed warning

Once-A-Day LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules are indicated for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD).

Important Safety Information

CONTRAINDICATIONS

The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR Capsules is contraindicated. The use of MAO inhibitors in combination with LUVOX CR Capsules, or within 14 days of discontinuing treatment with LUVOX CR Capsules, is contraindicated (see WARNINGS and PRECAUTIONS). LUVOX CR Capsules are also contraindicated in patients with a history of hypersensitivity to fluvoxamine maleate or any of its excipients.

ADVERSE EVENTS

In clinical trials, the most commonly observed adverse events with an incidence of ≥5% and at least twice that of placebo were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating. Overall, these side effects were mild to moderate in severity and transient in nature. Other common adverse events (≥5% and at least twice that of placebo) included abnormal ejaculation and anorgasmia.

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of LUVOX CR® (fluvoxamine maleate) Extended-Release Capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. LUVOX CR Capsules are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Please see full prescribing information, including boxed warning, for LUVOX CR.

References:

  1. ^ Luvox CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo Alto, CA; 2008.

LUVOX CR is a registered trademark of Solvay Pharmaceuticals, Inc.

© 2008 Jazz Pharmaceuticals, Inc.

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