Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 patients' 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 Warning and Precautions ( 5.1 ) ].
Adverse events reported at a rate of 0.5% or greater after receiving Technetium Tc 99m Sestamibi administration are shown in the following table: Table
Selected Adverse Events Reported in > 0.5 % of Patients Who Received Technetium Tc 99m Sestamibi in Either Breast or Cardiac Clinical Studies* Body System Breast Studies Cardiac Studies Women n = 673 Women n = 685 Men n = 2361 Total 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 was 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 Tc 99m Sestamibi.
5.1 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 Tc 99m Sestamibi use and is usually associated with exercise stress testing [ see General Precautions ( 5.2 ) ].
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.
Like all medications, Technetium Tc 99m Sestamibi can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: