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Safety

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Reyataz (atazanavir sulfate) Capsules March 2008


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

CONTRAINDICATIONS

  • Table 3: Drugs That Are Contraindicated with Reyataz

WARNINGS AND PRECAUTIONS

  • Drug Interactions
  • Cardiac Conduction Abnormalities
  • Rash
    • ...Toxic skin eruptions (added)
  • Hepatotoxicity

ADVERSE REACTIONS

  • Initial Section
  • Clinical Trial Experience in Adults
    • Treatment-Emergent Adverse Reactions in Treatment-Naive Patients
    • Treatment-Emergent Adverse Reactions in Treatment-Experienced Patients
  • Clinical Trial Experience in Pediatric Patients
  • Postmarketing Experience

DRUG INTERACTIONS

  • Potential for Reyataz to Affect Other Drugs
  • Potential for Other Drugs to Affect Atazanavir
  • Established and Other Potentially Significant Drug Interactions
    • Table 10
  • Drugs with No Observed or Predicted Interactions with Reyataz

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Pediatric Use
  • Impaired Renal Function
  • Impaired Hepatic Function

PATIENT COUNSELING INFORMATION

  • Initial Section
  • Rash

PATIENT PACKAGE INSERT

  • Can children take Reyataz?
  • What are the possible side effects of Reyataz?
    • The following side effects have been reported with Reyataz...

CONTRAINDICATIONS

Reyataz (atazanavir sulfate) is contraindicated:

  • in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the
    components of this product or to atazanavir.
  • when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance...

See highlighted text, Table 3: Drugs That Are Contraindicated with Reyataz.

WARNINGS AND PRECAUTIONS

Cardiac Conduction Abnormalities

...Atazanavir in combination with diltiazem increased diltiazem plasma concentration by 2-fold with an additive effect on the PR interval. When used in combination with atazanavir, a dose reduction of diltiazem by one half should be considered and ECG monitoring is recommended...

Rash

...Reyataz should be discontinued if severe rash develops. Cases of Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions have been reported in patients receiving Reyataz...

Hepatotoxicity

...In these patients, appropriate laboratory testing should be conducted prior to initiating therapy with Reyataz and these patients should be monitored during treatment...
    
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