Label Changes for:

Pristiq (desvenlafaxine) Extended-Release Tablets

December 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

 

December 2013

ADVERSE REACTIONS

Clinical Studies Experience

Patient exposure

  • PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure…

DRUG INTERACTIONS

Monoamine Oxidase Inhibitors (MAOI)
  • Do not use MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine. Do not use desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start desvenlafaxine in a patient who is being treated with linezolid or intravenous methylene blue
Serotonergic Drugs
  • Based on the mechanism of action of desvenlafaxine and the potential for serotonin syndrome, caution is advised when desvenlafaxine is co-administered with other drugs that may affect the serotonergic neurotransmitter systems
Potential for Other Drugs to Affect Desvenlafaxine
  • Based on in vitro data, no dose adjustment is required for PRISTIQ when used concomitantly with inhibitors of CYP3A4 and CYP1A1, 1A2, 2A6, 2D6, 2C8, 2C9, 2C19, 2E1, and the Pglycoprotein transporter. Clinical studies have demonstrated no clinically significant pharmacokinetic interaction between PRISTIQ and strong CYP 3A4 inhibitors
Potential for Desvenlafaxine to Affect Other Drugs
  • Clinical studies have shown that desvenlafaxine does not have a clinically relevant effect on CYP2D6 metabolism at the dose of 100 mg daily (Figure 2). Substrates primarily metabolized by CYP2D6 (e.g., desipramine , atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with PRISTIQ 100 mg or lower or when PRISTIQ is discontinued. Reduce the dose of these substrates by up to one-half if co-administered with 400 mg of PRISTIQ….
Drug-Laboratory Test Interactions
  • False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. This is due to lack of specificity of the screening tests. False positive test results may be expected for several days following discontinuation of desvenlafaxine therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish desvenlafaxine from PCP and amphetamine.

 

February 2013

ADVERSE REACTIONS

Clinical Studies Experience
Patient exposure
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