Label Changes for:

Xyrem (sodium oxybate) oral solution

April 2014

Changes have been made to the PRECAUTIONS sections of the safety label.

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

 

April 2014

7 DRUG INTERACTIONS

7.2 Divalproex Sodium
  • Concomitant use of Xyrem with divalproex sodium resulted in a 25% mean increase in systemic exposure to Xyrem (AUC ratio range of 0.8 to 1.7) and in a greater impairment on some tests of attention and working memory. An initial Xyrem dose reduction of at least 20% is recommended if divalproex sodium is prescribed to patients already taking Xyrem [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. Prescribers are advised to monitor patient response closely and adjust dose accordingly if concomitant use of Xyrem and divalproex sodium is warranted.

NOTE: added ..... information about drug reactions with ibuprofen, diclofenac, and extended-release valproate to Drug Interactions Studies in section 12 CLINICAL PHARMACOLOGY and 2.4 Dose Adjustment with Co-administration of Divalproex Sodium 

 

CONTRAINDICATIONS

  • Patients should not drink alcohol when using Xyrem.
 
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