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U.S. Department of Health and Human Services

Safety

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Edurant (Rilpivirine) Tablets

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

  

May 2014

Summary View

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

Summary View

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

Summary View

WARNINGS AND PRECAUTIONS

Immune Reconstitution Syndrome
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including Edurant…
  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.