NephroScan

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Have appropriate instruments and medications necessary for immediate treatment of allergic reactions and monitor patients for hypersensitivity reactions during and after administration ( 5.1 ) Radiation risks: Ensure safe handling to minimize radiation exposure to patients and health care workers ( 5.2 ) Risk in Patients with Advanced Renal Failure: Image interpretation may be affected as the kidneys may not absorb technetium Tc 99m succimer. ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including urticaria, rash, pruritus, and erythema have been reported with the use of technetium Tc 99m succimer injection in adults and pediatric patients. The time of onset of the reactions varied within 2 hours to several hours after the injection. Have appropriate instruments and medications necessary for immediate treatment of hypersensitivity reactions and monitor patients for reactions during and after administration [see Adverse Reactions (6) ] . 5.2 Radiation Risks Technetium Tc 99m succimer injection contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration [see Dosage and Administration (2.1 , 2.2) ] . 5.3 Risk in Patients with Advanced Renal Failure The use of technetium Tc 99m succimer injection in patients with severely reduced estimated glomerular filtration (eGFR) may have an effect on image interpretation as the kidneys may not absorb the technetium Tc 99m succimer and thus the Tc 99m succimer may distribute to organs or parts of the body other than the kidneys. It has been reported that satisfactory images may be obtained in some of these patients by delaying imaging between 6 hours to 24 hours [see Dosage and Administration (2.7) ] .

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of NEPHROSCAN were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders : Hypersensitivity including urticaria, rash, pruritus, and erythema General Disorders : syncope, fever, and nausea. The following adverse reactions have been reported: urticaria, rash, pruritus, erythema, syncope, fever, and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Theragnostics, Inc., at 1-888-286-3848 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.