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warnings and cautions
5 WARNINGS AND PRECAUTIONS • Treprostinil may cause symptomatic hypotension. ( 5.1 ) • Treprostinil inhibits platelet aggregation and increases the risk of bleeding. ( 5.2 ) • Dosage adjustments may be necessary if inhibitors or inducers of CYP2C8 are added or withdrawn. ( 5.3 , 7.1 ) • May cause bronchospasm: Patients with a history of hyperreactive airway disease may be more sensitive. ( 5.4 ) 5.1 Risk of Symptomatic Hypotension Treprostinil is a pulmonary and systemic vasodilator. In patients with low systemic arterial pressure, treatment with treprostinil may produce symptomatic hypotension. 5.2 Risk of Bleeding Treprostinil inhibits platelet aggregation and increases the risk of bleeding. 5.3 Effect of Other Drugs on Treprostinil Co-administration of a cytochrome P450 (CYP) 2C8 enzyme inhibitor (e.g., gemfibrozil) may increase exposure (both C max and AUC) to treprostinil. Co-administration of a CYP2C8 enzyme inducer (e.g., rifampin) may decrease exposure to treprostinil. Increased exposure is likely to increase adverse events associated with treprostinil administration, whereas decreased exposure is likely to reduce clinical effectiveness [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . 5.4 Bronchospasm Like other inhaled prostaglandins, YUTREPIA may cause acute bronchospasm. Patients with asthma or chronic obstructive pulmonary disease (COPD), or other bronchial hyperreactivity, are at increased risk for bronchospasm. Ensure that such patients are treated optimally for reactive airway disease prior to and during treatment with YUTREPIA.
6 ADVERSE REACTIONS The following potential adverse reactions are described in Warnings and Precautions ( 5 ): - Decrease in systemic blood pressure [see Warnings and Precautions ( 5.1 )] . - Bleeding [see Warnings and Precautions ( 5.2 )] . Most common adverse reactions with YUTREPIA (³10%) are cough, headache, throat irritation, and dizziness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Liquidia Technologies, Inc. at 1-888-393-LQDA (5732) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. The safety and tolerability of YUTREPIA was evaluated in an open label study (INSPIRE) of 121 patients with PAH (WHO Group 1 and NYHA Functional Class II [80 patients] and Class III [41 patients]) followed for up to 2 months. The most commonly reported adverse reactions included cough, headache, throat irritation, dizziness, which are known side effects of treprostinil inhalation solution. Table 2 lists the adverse reactions that occurred at a rate of at least 4% of the overall INSPIRE safety population. The adverse reactions in the INSPIRE study were consistent with those observed in previous studies of inhaled treprostinil. Table 2: Adverse Reactions Occurring in ≥ 4% of Patients in the INSPIRE Study *Transition: Patients were on stable doses of treprostinil inhalation solution for at least 3 months prior to enrollment in the study and transitioned to treatment with YUTREPIA. †Add-on: Patients were prostacyclin-naïve and were taking no more than 2 approved oral PAH therapies for at least 3 months at time of enrollment and addition of treatment with YUTREPIA. Adverse Reaction Transition* N=55 Add-On† N=66 n (%) n (%) Cough 15 (27) 36 (55) Headache 14 (25) 18 (27) Throat Irritation 5 (9) 14 (21) Dizziness 6 (11) 7 (11) Diarrhea 3 (6) 8 (12) Chest Discomfort 5 (9) 5 (8) Nausea 4 (7) 5 (8) Dyspnea 3 (6) 3 (5) Flushing 1 (2) 5 (8) Oropharyngeal Pain 1 (2) 4 (6) 6.2 Adverse Reactions Identified in Post-Marketing Experience The following adverse reaction has been identified during the post-approval use of treprostinil inhalation solution. 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
adverse reactions table
<table ID="_Ref198876291" cellpadding="3.6pt" width="50%"><caption>Table 2: Adverse Reactions Occurring in ≥ 4% of Patients in the INSPIRE Study</caption><col width="23%"/><col width="17%"/><col width="17%"/><tfoot><tr><td align="left" colspan="3" valign="top">*Transition: Patients were on stable doses of treprostinil inhalation solution for at least 3 months prior to enrollment in the study and transitioned to treatment with YUTREPIA. †Add-on: Patients were prostacyclin-naïve and were taking no more than 2 approved oral PAH therapies for at least 3 months at time of enrollment and addition of treatment with YUTREPIA.</td></tr></tfoot><tbody><tr><td rowspan="2" valign="bottom"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td align="center" valign="bottom"><paragraph><content styleCode="bold">Transition* N=55</content></paragraph></td><td align="center" valign="bottom"><paragraph><content styleCode="bold">Add-On† N=66</content></paragraph></td></tr><tr><td align="center" styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td align="center" styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td styleCode="Toprule " valign="bottom"><paragraph>Cough</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>15 (27)</paragraph></td><td align="center" styleCode="Toprule " valign="top"><paragraph>36 (55)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Headache</paragraph></td><td align="center" valign="top"><paragraph>14 (25)</paragraph></td><td align="center" valign="top"><paragraph>18 (27)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Throat Irritation</paragraph></td><td align="center" valign="top"><paragraph>5 (9)</paragraph></td><td align="center" valign="top"><paragraph>14 (21)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Dizziness</paragraph></td><td align="center" valign="top"><paragraph>6 (11)</paragraph></td><td align="center" valign="top"><paragraph>7 (11)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Diarrhea</paragraph></td><td align="center" valign="top"><paragraph>3 (6)</paragraph></td><td align="center" valign="top"><paragraph>8 (12)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Chest Discomfort</paragraph></td><td align="center" valign="top"><paragraph>5 (9)</paragraph></td><td align="center" valign="top"><paragraph>5 (8)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Nausea</paragraph></td><td align="center" valign="top"><paragraph>4 (7)</paragraph></td><td align="center" valign="top"><paragraph>5 (8)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Dyspnea</paragraph></td><td align="center" valign="top"><paragraph>3 (6)</paragraph></td><td align="center" valign="top"><paragraph>3 (5)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Flushing</paragraph></td><td align="center" valign="top"><paragraph>1 (2)</paragraph></td><td align="center" valign="top"><paragraph>5 (8)</paragraph></td></tr><tr><td valign="bottom"><paragraph>Oropharyngeal Pain</paragraph></td><td align="center" valign="top"><paragraph>1 (2)</paragraph></td><td align="center" valign="top"><paragraph>4 (6)</paragraph></td></tr></tbody></table>