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Miraluma

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Miraluma

Miraluma Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Miraluma Kit for the Preparation of Technetium Tc99m Sestamibi for Injection is a diagnostic agent used for breast imaging to evaluate breast lesions in patients with an abnormal mammogram. Common side effects include breast pain, headache, changes in taste or smell, or digestive problems.

The recommended dose range for I.V. administration of Miraluma for breast imaging is a single dose of 740-1110 MBq (20 - 30 mCi). Miraluma may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Miraluma 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 Miraluma Kit for the Preparation of Technetium Tc99m 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.

Miraluma FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Miraluma (Technetium Tc99m sestamibi) »

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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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