Kit for the Preparation of Technetium Tc99m Sestamibi Injection

Warnings and precautions

• Death infrequently has occurred 4 to 24 hours after Technetium Tc99m Sestamibi use and is usually associated with exercise stress testing. Continuous monitoring and treatment should be assured in patients with known or suspected cardiac disease.
• Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events. Caution should be used when pharmacologic stress is selected as an alternative to exercise; it should be used when indicated and in accordance with the pharmacologic stress agent’s labeling.
• Technetium Tc99m Sestamibi has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria. In some patients the allergic symptoms developed on the second injection during Tc99m Sestamibi imaging. Caution should be used and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Patients should be asked about the possibility of allergic reactions to the drug before administration of Technetium Tc99m Sestamibi.
• The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
• Radioactive drugs must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel and patients.
• Contents of the kit before preparation are not radioactive. However, after the Sodium Pertechnetate Tc99m Injection is added, adequate shielding of the final preparation must be maintained and care should be taken to minimize radiation exposure.
• It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation.
• Technetium Tc99m labeling reactions depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc99m Injection containing oxidants should not be used.
• Technetium Tc99m Sestamibi should not be used more than six hours after preparation.
• Radiopharmaceuticals should be used only by physicians whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
• Stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

Adverse reactions

• Serious adverse reactions include arrhythmia, angioedema, angina, seizure, chest pain, severe hypersensitivity, dyspnea and death.
• Common adverse reactions include taste perversion, changes in special senses and disorders of body as a whole.

Use in specific populations

• Safety and effectiveness in the pediatric population have not been established.
• Limited available data with Technetium Tc99m Sestamibi use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
• Interruption of breastfeeding is not necessary, however, a lactating woman should consider restricting close contact with her breast fed infant to a maximum of 5 hours in the 24 hour period after Technetium Tc99m Sestamibi administration to minimize radiation exposure.