TECHNEGAS

5 WARNINGS AND PRECAUTIONS Decreased Oxygen Saturation: Monitor oxygen saturation with continuous pulse oximetry. If clinically indicated, allow patients to breathe room air throughout the procedure and consider administration of supplemental oxygen before and at any time during the procedure. (5.1) Radiation Exposure Risk: Ensure safe handling and preparation procedures to protect patients and health care providers from unintentional radiation exposure. (2.1, 5.2) 5.1 Decreased Oxygen Saturation Decrease in oxygen saturation may occur during or after the inhalation of Technegas Aerosol. Oxygen saturation nadirs as low as 60% have been reported in a published study [see Adverse Reactions (6.1)]. In an efficacy trial, 79% of patients received supplemental oxygen or had the flow of Technegas Aerosol interrupted. Patients with compromised respiratory function may be at increased risk for decreased oxygen saturation. Monitor oxygen saturation with continuous pulse oximetry. If clinically indicated, allow patients to breathe room air throughout the procedure and consider administration of supplemental oxygen before and at any time during the procedure. 5.2 Radiation Exposure Risk Technegas Aerosol contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care providers from unintentional radiation exposure. 5.3 Bronchospasm As with other inhaled aerosol medications, Technegas Aerosol may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity, such as patients with asthma or other lung or allergic disorders. Monitor all patients for bronchospasm.

5.1 Decreased Oxygen Saturation Decrease in oxygen saturation may occur during or after the inhalation of Technegas Aerosol. Oxygen saturation nadirs as low as 60% have been reported in a published study [see Adverse Reactions (6.1)]. In an efficacy trial, 79% of patients received supplemental oxygen or had the flow of Technegas Aerosol interrupted. Patients with compromised respiratory function may be at increased risk for decreased oxygen saturation. Monitor oxygen saturation with continuous pulse oximetry. If clinically indicated, allow patients to breathe room air throughout the procedure and consider administration of supplemental oxygen before and at any time during the procedure.

5.2 Radiation Exposure Risk Technegas Aerosol contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care providers from unintentional radiation exposure.

5.3 Bronchospasm As with other inhaled aerosol medications, Technegas Aerosol may result in acute bronchoconstriction, especially in patients with heightened bronchoreactivity, such as patients with asthma or other lung or allergic disorders. Monitor all patients for bronchospasm.

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Decreased Oxygen Saturation [see Warnings and Precautions (5.1)] The most common adverse reaction (≥ 1%) was hypoxia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Cyclomedica Australia Pty Ltd at toll free phone number 1-888-8-586-4396 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 clinical practice. The safety of Technegas Aerosol was evaluated in 291 patients undergoing ventilation studies with prospective data collection. Patients received an amount of Technegas Aerosol to achieve 1,500 cps to 2,500 cps by oral inhalation. The mean age of patients was 60 years (range:18 to 95 years); distribution by race was 92 % White, 7% Black or African American, 0.3 % Asian, and 0.3 % unreported; and distribution by ethnicity was 4% Hispanic/Latino and 96 % non-Hispanic/Latino. Adverse reactions were reported in 10 patients (3.4%). The adverse reaction occurring at ≥ 1% in patients receiving Technegas Aerosol was hypoxia (1%). Adverse reactions reported at < 1% were dizziness, dysgeusia, cough, dyspnea [not otherwise specified], throat irritation, and upper respiratory tract congestion. In one published study, oxygen saturation was monitored in a series of patients undergoing Technegas Aerosol ventilation scintigraphy for suspected pulmonary embolism (n=28) or pulmonary disease (n=10). Of these 38 patients without pre-oxygenation, oxygen saturation fell to < 90% in 26 (68%) patients and < 85% in 15 (39%) patients. The recorded lowest value for each patient was usually observed after the first or second inhalation.