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Label Changes for:

Tyvaso (treprostinil)

June 2016

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

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

June 2016

WARNINGS AND PRECAUTIONS

Risk of Bleeding
  • (Add) Tyvaso inhibits platelet aggregation and increases the risk of bleeding.

ADVERSE REACTIONS

Adverse Reactions Identified in Clinical Trials
  • (Addition) In a prospective, observational study comparing patients taking Tyvaso (958 patient years of exposure) and a control group (treatment with other approved therapies for PAH; 1094 patient-years), Tyvaso was associated with a higher rate of cough (16.2 per 100 patient-years vs. 10.9 per 100 pt-years), throat irritation (4.5 per 100 pt-years vs. 1.2 per 100 pt-years), nasal discomfort (2.6 per 100 pt-years vs. 1.3 per 100 pt-years), and haemoptysis (2.5 per 100 pt-years vs. 1.3 per 100 pt-years) compared to the control group.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

  • (Addition) Also, a study in pregnant rabbits administered oral treprostinil diolamine at exposures higher than those in humans resulted in external fetal and soft tissue malformations and fetal skeletal malformations.

 

April 2013

ADVERSE REACTIONS

Adverse Reactions Identified in Clinical Trials
  • …2.3 years, with a maximum exposure of 5.4 years. Eighty-nine (89%) percent of patients achieved the target dose of nine breaths, four times daily. Forty-two (42%) percent achieved a dose of 12 breaths four times daily.
  • Adverse Reactions Identified in Post-Marketing Experience - The following adverse reaction has been identified during the postapproval use of Tyvaso: Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure: Angioedema.

 

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