Label Changes for:

Tracleer (bosentan) 62.5 and 125 mg Tablets

March 2009

Changes have been made to the CONTRAINDICATIONS and PRECAUTIONS sections of the safety label.

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


Summary View

Sections Modified

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Lopinavir/ritonavir or other ritonavir-containing HIV regimens

PRECAUTIONS

  • Drug Interactions (section reworded)
    • Bosentan is metabolized by CYP2C9 and CYP3A4. Inhibition of these enzymes may increase the plasma concentration of bosentan...
  • Lopinavir/ritonavir or other ritonavir-containing HIV regimens
    • Co-administration of Tracleer in healthy subjects resulted in initial and steady...

MEDICATION GUIDE

  • Do not take Tracleer if...
    • lopinavir/ritonavir or other ritonavir-containing HIV regimens
  • Tell your doctor about all the medicines you use..
    • lopinavir/ritonavir or other ritonavir-containing HIV regimens
  • What should I avoid..
    • Do not take cyclosporine-A...increase your chance of side effects
    • Do not take lopinavir/ritonavir or other ritonavir-containing HIV regimens

CONTRAINDICATIONS

  • Lopinavir/ritonavir or other ritonavir-containing HIV regimens
    • Co-administration of lopinavir/ritonavir and bosentan resulted in markedly increased plasma concentrations of bosentan.Therefore, concomitant use of Tracleer and lopinavir/ritonavir or other ritonavir-containing HIV regimens is contraindicated...
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