Label Changes for:

Remodulin (treprostinil sodium) Injection

February 2008

Changes have been made to the WARNINGS and ADVERSE REACTIONS 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

  • Adverse Events Attributable to the Intravenous Drug Delivery System

ADVERSE REACTIONS

  • Adverse Events Attributable to the Drug Delievery System
    • ...In addition to these adverse events due to the drug delivery system during subcutaneous administration...
  • Adverse Events Observed During Clinical Practice
    • ...These events are thrombophlebitis associated with peripheral intravenous infusion, thrombocytopenia and bone pain...

WARNINGS

Adverse Events Attributable to the Intravenous Drug Delivery System

Chronic intravenous infusions of Remodulin are delivered using an indwelling central venous catheter. This route is associated with the risk of blood stream infections (BSI) and sepsis, which may be fatal.

In an open-label study of IV treprostinil (n=47), there were seven catheter-related line infections during approximately 35 patient years, or about 1 BSI event per 5 years of use. A CDC survey of seven sites that used IV treprostinil for the treatment of PAH found approximately 1 BSI (defined as any positive blood culture) event per 3 years of use.

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