Rubidium Rb 82

1 INDICATIONS AND USAGE RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous administration. Rubidium Rb 82 chloride injection is indicated for Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate regional myocardial perfusion in adult patients with suspected or existing coronary artery disease. RUBY-FILL is a closed system used to produce rubidium Rb 82 chloride injection for intravenous use.

6 ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Jubilant DraxImage Inc., dba Jubilant Radiopharma TM at 1-888-633-5343 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reaction associated with the use of rubidium Rb 82 chloride was identified in clinical trials or post marketing reports. Because these reactions are 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.

8.1 Pregnancy Risk Summary There are no data available on the use of rubidium Rb 82 in pregnant women. Animal reproduction studies with rubidium Rb 82 chloride have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. If considering rubidium Rb 82 chloride injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from Rb 82 and the gestational timing of exposure.

WARNING: HIGH LEVEL RADIATION EXPOSURE WITH USE OF INCORRECT ELUENT AND FAILURE TO FOLLOW QUALITY CONTROL TESTING PROCEDURE High Level Radiation Exposure with Use of Incorrect Eluent Patients are exposed to high radiation levels when the generator is eluted with the incorrect eluent due to high Sr 82 and Sr 85 breakthrough levels [see Warnings and Precautions ( 5.1 )] Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator [see Dosage and Administration ( 2.5 )] Immediat... 5 WARNINGS AND PRECAUTIONS •Pharmacologic induction of cardiovascular stress: May be associated with serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events. Perform testing only in setting where cardiac resuscitation equipment and trained staff are readily available. ( 5.3 ) 5.1 High Level Radiation Exposure with Use of Incorrect Eluent Use only additive-free 0.9% Sodium Chloride Injection USP to elute the generator. Apply the provided saline confirmation label to the additive-free 0.9% Sodium Chloride Injection USP bag before use. 4 CONTRAINDICATIONS RUBY-FILL is contraindicated for use if a solution other than additive-free 0.9% Sodium Chloride Injection USP has been used to elute the generator at any time.