Treprostinil Inhalation Solution

The following potential adverse reactions are described in WARNINGS AND PRECAUTIONS:

• Decrease in systemic blood pressure [see WARNINGS AND PRECAUTIONS].
• Bleeding [see WARNINGS AND PRECAUTIONS].

Adverse Reactions Identified In Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 12-week placebo-controlled study (TRIUMPH I) of 235 patients with PAH (WHO Group 1 and nearly all NYHA Functional Class III), the most commonly reported adverse reactions on Tyvaso included: cough and throat irritation; headache, gastrointestinal effects, muscle, jaw or bone pain, flushing and syncope. Table 1 lists the adverse reactions that occurred at a rate of at least 4% and were more frequent in patients treated with Tyvaso than with placebo.

Table 1: Adverse Events in ≥ 4% of PAH Patients Receiving Tyvaso and More Frequent than Placebo

The safety of Tyvaso was also studied in a long-term, open-label extension study in which 206 patients were dosed for a mean duration of 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. The adverse events during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo controlled trial.

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.

Adverse events in the treated group during the double-blind and open-label phase reflecting irritation to the respiratory tract included: cough, throat irritation, pharyngeal pain, epistaxis, hemoptysis and wheezing. Serious adverse events during the open-label portion of the study included pneumonia in fifteen subjects. There were three serious episodes of hemoptysis (one fatal) noted during the openlabel experience.

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.

Read the entire FDA prescribing information for Tyvaso (Treprostinil Inhalation Solution)

TREPROSTINIL is used to treat pulmonary arterial hypertension. This medicine helps to improve exercise ability and quality of life.

This drug also comes in other forms, including Injectable solution, Oral tablet

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