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Miraluma

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Miraluma

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 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 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 Miraluma (technetium tc99m sestamibi) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Specific drug-drug interactions have not been studied.

Drug Abuse And Dependence

Controlled Substance

Not applicable.

Abuse

Not applicable.

Dependence

Not applicable.

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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Report Problems to the Food and Drug Administration

 

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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