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U.S. Department of Health and Human Services

Safety

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Lexiva (fosamprenavir calcium) tablets and oral suspension

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

 

Summary View

 

WARNINGS AND PRECAUTIONS

Lipid Elevations
  • cholesterol added to section
Nephrolithiasis
  • Cases of nephrolithiasis were reported during postmarketing surveillance in HIV-infected patients receiving Lexiva.  Because these events were reported voluntarily during clinical practice, estimates of frequency cannot be made. If signs or symptoms of nephrolithiasis occur, temporary interruption or discontinuation of therapy may be considered.

ADVERSE REACTIONS

Postmarketing Experience
  • myocardial infarction, hypercholesterolemia, oral parathesia and nephrolithiasis

PATIENT PACKAGE INSERT

What are the possible side effects of Lexiva
  • the signs and symptoms of kidney stones
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