Label Changes for:
Tyvaso (Treprostinil) Inhalation Solution
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013
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.