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U.S. Department of Health and Human Services

Safety

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Kaletra (lopinavir/ritonavir) 200 mg/50 mg, 100 mg/25 mg Tablets and Kaletra (lopinavir/ritonavir) 80 mg/20mg per ml Oral Solution

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

 

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.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • PR Interval Prolongation
  • QT Interval Prolongation

 

ADVERSE REACTIONS

  • Information regarding incidence of diarrhea in Study 730 is included in section 6 Adverse Reactions. Information from study 418 comparing once daily and twice daily dosing of Kaletra capsules was removed from the label because the capsule formulation is no longer marketed and Study 730 provides the more relevant longer term data for once daily and twice daily dosing with Kaletra tablets.

 

MEDICATION GUIDE

 

WARNINGS and PRECAUTIONS

  • PR Interval Prolongation
    • Lopinavir/ritonavir prolongs the PR interval in some patients...
    • The impact on the PR interval of co-administration of Kaletra with other drugs that prolong the PR
      interval...
  • QT Interval Prolongation
    • Postmarketing cases of QT interval prolongation and torsade de pointes have been reported although causality of Kaletra could not be established.

 

ADVERSE REACTIONS

  • Adults - Clinical Trials Experience
    • The most common adverse reaction was diarrhea, which was generally of mild to moderate severity. In study 730, the incidence of diarrhea of any severity during 48 weeks of therapy was 60% in patients receiving Kaletra tablets once daily compared to 57% in patients receiving Kaletra tablets twice daily. More patients receiving Kaletra tablets once-daily (14, 4.2%) had ongoing diarrhea at the time of discontinuation as compared to patients receiving Kaletra tablets twice-daily (6, 1.8%). In study 730, discontinuations due to any adverse reaction were 4.8% in patients receiving Kaletra tablets once-daily as compared to 3% in patients receiving Kaletra tablets twice-daily....

 

MEDICATION GUIDE

  • New Med Guide
    • Convert the patient package insert to a Medication Guide that includes information related to cardiac abnormalities