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Label Changes for:

Edurant (rilpivirine) tablets

May 2014

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

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

  

May 2014

4 CONTRAINDICATIONS

  • the antimycobacterials rifampin, rifapentine

6 ADVERSE REACTIONS

  • Clinical Trials Experience section, revised adrenal function and lipid values

7 DRUG INTERACTIONS

  • Drug-drug interaction table edited - rilpivirine, rifabutin, metformin

 

December 2012

WARNINNGS AND PRECAUTIONS

  • Depressive Disorders: The adverse reaction depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) has been reported with Edurant…
  • Hepatotoxicity: Hepatic adverse events have been reported in patients receiving a Rilpivirine containing regimen.,,

 

August 2012

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
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