- Clinician Information:
Cardiolite Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cardiolite (prep kit for technetium tc99 sestamibi for injection) is a myocardial perfusion agent used to detect coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. This medication is available in generic form. Common side effects include headache, changes is taste or smell, abdominal discomfort, nausea, and cardiovascular effects.
For myocardial imaging the suggested dose range for I.V. administration of Cardiolite in a single dose to be employed in the average patient (70 Kg) is 370-1110 MBq (10-30 mCi). Cardiolite may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Cardiolite should be used only if prescribed. It is unknown if this drug passes into breast milk. Formula feedings should be substituted for breast feedings. Consult your doctor before breastfeeding.
Our Cardiolite (prep kit for technetium tc99 sestamibi for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cardiolite FDA Prescribing Information: Side Effects
Adverse events were evaluated in 3741 adults who were evaluated in clinical studies. Of these patients, 3068 (77% men, 22% women, and 0.7% of the patient's genders were not recorded) were in cardiac clinical trials and 673 (100% women) in breast imaging trials. Cases of angina, chest pain, and death have occurred (see WARNINGS AND PRECAUTIONS). Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc99m Sestamibi administration are shown in the following table:
Table 2.0 - Selected Adverse Events Reported in > 0.5%
of Patients Who Received Technetium Tc99m Sestamibi in Either Breast or Cardiac
|Body System||Breast Studies||Cardiac Studies|
n = 673
n = 685
n = 2361
n = 3046
|Body as a Whole||21 (3.1%)||6 (0.9%)||17 (0.7%)||23 (0.8%)|
|Headache||11 (1.6%)||2 (0.3%)||4 (0.2%)||6 (0.2%)|
|Cardiovascular||9 (1.3%)||24 (3.5%)||75 (3.2%)||99 (3.3%)|
|Chest Pain/Angina||0 (0%)||18 (2.6%)||46 (1.9%)||64 (2.1%)|
|ST segment changes||0 (0%)||11 (1.6%)||29 (1.2%)||40 (1.3%)|
|Digestive System||8 (1.2%)||4 (0.6%)||9 (0.4%)||13 (0.4%)|
|Nausea||4 (0.6%)||1 (0.1%)||2 (0.1%)||3 (0.1%)|
|Special Senses||132 (19.6%)||62 (9.1%)||160 (6.8%)||222 (7.3%)|
|Taste Perversion||129 (19.2%)||60 (8.8%)||157 (6.6%)||217 (7.1%)|
|Parosmia||8 (1.2%)||6 (0.9%)||10 (0.4%)||16 (0.5%)|
|*Excludes the 22 patients whose gender were not recorded.|
In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures.
The following adverse reactions have been reported in ≤ 0.5% of patients: signs and symptoms consistent with seizure occurring shortly after administration of the agent; transient arthritis; angioedema, arrhythmia, dizziness, syncope, abdominal pain, vomiting, and severe hypersensitivity characterized by dyspnea, hypotension, bradycardia, asthenia, and vomiting within two hours after a second injection of Technetium Tc99m Sestamibi. A few cases of flushing, edema, injection site inflammation, dry mouth, fever, pruritus, rash, urticaria and fatigue have also been attributed to administration of the agent.
Read the entire FDA prescribing information for Cardiolite (Prep kit for Technetium Tc99 Sestamibi for Injection) »
Additional Cardiolite Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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