Tetrofosmin

MYOVIEW 30 mL is a kit for the preparation of technetium Tc99m tetrofosmin for injection. Technetium Tc99m tetrofosmin injection is a radioactive diagnostic agent indicated for the following: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease. Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease

Technetium (99mTc) tetrofosmin is a lipophilic, cationic complex which diffuses passively through the cell membrane and is locally retained actively due to the presence of intact mitochondria reflecting the presence of viable cells. After intravenous injection, it is distributed within the myocardium according to myocardial perfusion and viability.

Use appropriate radiation safety measures and aseptic technique during preparation and handling. The recommended dose range for MYOVIEW for rest or stress imaging is 185 to 1,221 megabecquerels (MBq) [5 to 33 millicuries (mCi)] by intravenous administration. When rest and stress injections are administered on the same day, the first dose should be 185 to 444 MBq (5 to 12 mCi) followed by the second dose of 555 to 1,221 MBq (15 to 33 mCi) given approximately 1 to 4 hours later. The recommended dose range for MYOVIEW for ventricular function assessment is 185 to 1,221 MBq (5 to 33 mCi) as an intravenous injection. See Full Prescribing Information for instructions for preparation and determination of radiochemical purity. Imaging may begin 15 minutes following administration of the agent

None. None

Risk with exercise or pharmacologic stress: Continuous cardiac monitoring should be performed in studying patients with known or suspected coronary artery disease. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent's prescribing information. Appropriate safety measures should be used to minimize radiation exposure to clinical personnel and to the patient consistent with proper patient management

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Most common adverse reactions (incidence < 1%) after MYOVIEW injection: Cardiovascular: angina, hypertension, torsades de pointes. Gastrointestinal: vomiting, abdominal discomfort. Hypersensitivity: cutaneous allergy, hypotension, dyspnea. Special Senses: metallic taste, burning of the mouth, smell alteration.

Store the kit at 2° to 8°C (36° to 46°F), protected from light. Store the radiolabeled vial at 2° to 25°C (36° to 77°F), using appropriate radiation shielding. This reagent kit is approved for use by persons under license by the Nuclear Regulatory Commission or the relevant regulatory authority of an Agreement State, store and dispose of technetium Tc99m tetrofosmin in accordance with these regulations.