Cardiolite

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Warnings

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.

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 (prep kit for technetium tc99 sestamibi for injection) ® imaging. Patients who receive CARDIOLITE (prep kit for technetium tc99 sestamibi for injection) ® 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 (prep kit for technetium tc99 sestamibi for injection) ® or MIRALUMA®, patients should be asked about the possibility of allergic reactions to either drug.

General Precautions

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.

Radio pharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radio nuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radio nuclides.

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:

Fatigue 35%
Dyspnea 17%
Chest Pain 16%
ST-depression 7%
Arrhythmia 1%

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In comparison with most other diagnostic technetium labeled radio pharmaceuticals, the radiation dose to the ovaries (1.5 rads/30 mCi at rest, 1.2 rads/30 mCi 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).

Use In Specific Patients

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.

Nursing Mothers

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.

Pediatric Use

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

No evidence of diagnostic efficacy or clinical utility of Cardiolite (prep kit for technetium tc99 sestamibi for injection) scan was found in clinical studies of children and adolescents with Kawasaki disease.

A prospective study of 445 pediatric patients with Kawasaki disease was designed to determine the predictive value of Cardiolite (prep kit for technetium tc99 sestamibi for injection) rest and stress myocardial perfusion imaging to define a pediatric population with Kawasaki disease that was at risk of developing cardiac events. Cardiac events were defined as cardiac death, MI, hospitalization due to cardiac etiology, heart failure, CABG or coronary angioplasty. The standard of truth was defined as cardiac events occurring 6 months following the administration of Cardiolite (prep kit for technetium tc99 sestamibi for injection) . Only three cardiac events were observed at six months in this study. In all three cases, the scan was negative. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study.

A ten year retrospective case history study of pediatric Kawasaki disease patients who completed Cardiolite (prep kit for technetium tc99 sestamibi for injection) myocardial perfusion imaging and who had coronary angiography within three months of the Cardiolite (prep kit for technetium tc99 sestamibi for injection) scan was designed to measure sensitivity and specificity of Cardiolite (prep kit for technetium tc99 sestamibi for injection) scan. Out of 72 patients who had both evaluable Cardiolite (prep kit for technetium tc99 sestamibi for injection) scans and evaluable angiographic images, only one patient had both an abnormal angiogram and an abnormal Cardiolite (prep kit for technetium tc99 sestamibi for injection) scan. No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study.

In a clinical pharmacology study, 46 pediatric patients with Kawasaki disease received Cardiolite (prep kit for technetium tc99 sestamibi for injection) administration at the following doses: 0.1-0.2 mCi/kg for rest, 0.3 mCi/kg for stress in one day studies; 0.2 mCi/kg for rest and 0.2 mCi/kg for stress in two day studies. The radioactivity both in younger children and in adolescents exhibited PK profiles similar to those previously reported in adults (See CLINICAL PHARMACOLOGY, Pharmacokinetics). The radiation absorbed doses in adolescents, both at rest and stress, were similar to those observed in adults (see DOSAGE AND ADMINISTRATION, Radiation Dosimetry). When comparing weight-adjusted radioactivity (up to 0.3 mCi/kg) doses administered to adolescents and younger children to the recommended dose administered to adults (up to 30 mCi), the radiation absorbed doses in both adolescents and younger children were similar to those in adults.

Adverse events were evaluated in 609 pediatric patients from the three clinical studies described above. The frequency and the type of the adverse events were similar to the ones observed in the studies of Cardiolite (prep kit for technetium tc99 sestamibi for injection) in adults. Two of the 609 had a serious adverse event: one patient received a CARDIOLITE (prep kit for technetium tc99 sestamibi for injection) ® overdose but remained asymptomatic, and one patient had an asthma exacerbation following administration.

Geriatric Use

Of 3068 patients in clinical studies of CARDIOLITE (prep kit for technetium tc99 sestamibi for injection) ® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), 693 patients were 65 or older and 121 were 75 or older.

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.

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.

Last reviewed on RxList: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.

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