Label Changes for:

Isentress (raltegravir potassium) Tablets

November 2011

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

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

 

 

November 2011 

WARNINGS AND PRECAUTIONS

Severe Skin and Hypersensitivity Reactions
  • Severe, potentially life-threatening, and fatal skin reactions have been reported. These include cases of Stevens-Johnson syndrome and toxic epidermal necrolysis. Hypersensitivity reactions have also been reported and were characterized by rash, constitutional findings, and sometimes, organ dysfunction, including hepatic failure. Discontinue ISENTRESS and other suspect agents immediately if signs or symptoms of severe skin reactions or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema). Clinical status including liver aminotransferases should be monitored and appropriate therapy initiated. Delay in stopping ISENTRESS treatment or other suspect agents after the onset of severe rash may result in a life-threatening reaction.

ADVERSE REACTIONS

Postmarketing Experience
  • Cerebellar ataxia          

 

April 2011 

 

6 ADVERSE REACTIONS

6.2 Post-Marketing Experience
  • ...hepatic failure...

 

February 2011 

 

ADVERSE REACTIONS

Postmarketing Experience
  • diarrhea

PATIENT COUNSELING INFORMATION

What are the possible side effects of Isentress?
  • …diarrhea

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.

October 2008

Summary View

 

Sections Modified

ADVERSE REACTIONS

  • Postmarketing Experience
    • Skin and Subcutaneous Tissue Disorders
      • rash, Stevens-Johnson syndrome

PATIENT PACKAGE INSERT

  • What are the possible side effects of Isentress?
    • Other side effects include rash and severe skin reactions (added)

 

 

November 2011 

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