Label Changes for:

Reyataz (atazanavir sulfate) Capsules

February 2008

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


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

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.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS

  • Drug Interactions
    • Rosuvastatin
  • Cardiac Conduction Abnormalities

ADVERSE REACTIONS

  • Postmarketing Experience
    • Cardiovascular System
      • Second-degree AV block
      • Third-degree AV block
      • Left Bundle Branch Block
      • QTc Prolongation...
    • Hepatobiliary Disorders
      • Cholelithiasis
      • Cholecystitis
      • Cholestasis

PATIENT PACKAGE INSERT

  • What are the possible side effects of Reyataz?
  • What important information should I know about taking Reyataz with other medicines?
  • How should I store Reyataz?

WARNINGS

Drug Interactions: Rosuvastatin

...Use the lowest possible dose of atorvastatin or rosuvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as pravastatin or fluvastatin when in concomitant use with Reyataz. The risk of myopathy, including rhabdomyolysis, may be increased when HIV protease inhibitors, including Reyataz, are used in combination with these drugs.

Cardiac Conduction Abnormalities

Atazanavir has been shown to prolong the PR interval of the electrocardiogram in some patients. In healthy volunteers and in patients, abnormalities in atrioventricular (AV) conduction were asymptomatic and generally limited to first-degree AV block. There have been rare reports of second-degree AV block and other conduction abnormalities...

Label approved 02/20/2008 not available on Drugs@FDA

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