In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Precautions).

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 CARDIOLITE^® imaging. Patients who receive CARDIOLITE^® or MIRALUMA^® imaging are receiving the same drug. Caution should be exercised and emergency equipment should be available when administering Technetium Tc99m Sestamibi. Also, before administering either CARDIOLITE^® or MIRALUMA^®, patients should be asked about the possibility of allergic reactions to either drug.

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. Also, care should be taken to minimize radiation exposure to the patients consistent with proper patient management.

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.

The components of the kit are sterile and non-pyrogenic. 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 who are qualified by training and experience in the safe use and handling of radionuclides and 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.

The most frequent exercise stress test endpoints sufficient to stop the test reported during controlled studies (two-thirds were cardiac patients) were:

In comparison with most other diagnostic technetium labeled radiopharmaceuticals, the radiation dose to the ovaries (1.5 rads/30 mCi at rest, 1.2 rads/30mCi at exercise) is high. Minimal exposure (ALARA) is necessary in women of childbearing capability. (See Dosimetry subsection in DOSAGE and ADMINISTRATION section.)

The active intermediate, Cu(MIBI)₄BF₄, was evaluated for genotoxic potential in a battery of five

tests. No genotoxic activity was observed in the Ames, CHO/HPRT and sister chromatid exchange tests (all in vitro). At cytotoxic concentrations (> 20 µg/ml), an increase in cells with chromosome aberrations was observed in the in vitro human lymphocyte assay. Cu(MIBI)₄BF₄ did not show genotoxic effects in the in vivo mouse micronucleus test at a dose which caused systemic and bone marrow toxicity (9 mg/kg, > 600 X maximal human dose).

Pregnancy Category C

Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc99m Sestamibi. It is also not known whether Technetium Tc99m Sestamibi can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. There have been no studies in pregnant women. Technetium Tc99m Sestamibi should be given to a pregnant woman only if clearly needed.

Technetium Tc99m Pertechnetate is excreted in human milk during lactation. It is not known whether Technetium Tc99m Sestamibi is excreted in human milk. Therefore, formula feedings should be substituted for breast feedings.

Safety and effectiveness in the pediatric population have not been established.

Of 673 patients in clinical studies of MIRALUMA^® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), 138 patients were 65 or older and 30 were 75 or older.

Of 3068 patients in clinical studies of CARDIOLITE^® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), 693 patients were 65 or older and 121 were 75 or older.

Based on the evaluation of the frequency of adverse events and review of vital signs data, no overall differences in safety were observed between these subjects and younger subjects. Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

Bookmark this page: