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 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 Warnings and Precautions). Adverse events reported at a rate of 0.5% or greater reported after receiving Technetium Tc99m Sestamibi administration are shown in the following table:
| Table 9 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 | Women | Men | Total | |
| n = 673 | n = 685 | n = 2361 | n = 3046 | |
| Body as a Whole | 21 (3.1%) | 6 (0.9%) | 17 (0.7%) | 23 (0.8%) |
| 11 (1.6%) | 2 (0.3%) | 4 (0.2%) | 6 (0.2%) | |
| 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%) |
| 8 (1.2%) | 4 (0.6%) | 9 (0.4%) | 13 (0.4%) | |
| 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, arrythmia, 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, pruritis, rash, urticaria and fatigue have also been attributed to administration of the agent.
DRUG INTERACTIONS
Specific drug-drug interactions have not been studied.
Generic Name: Technetium Tc99m sestamibi
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ENABLEX is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:
- · having a strong need to go to the bathroom right away (also called "urgency")
- · leaks or wetting accidents (also called "urinary incontinence")
- · having to go to the bathroom too often (also called "urinary frequency")
IMPORTANT SAFETY INFORMATION
You should not take once-daily ENABLEX if you have certain types of stomach problems, glaucoma, or have trouble emptying your bladder. Side effects of ENBLEX include blurred vision, and more commonly dry mouth, constipation, indigestion, and abdominal pain. Use caution when doing certain activities until you know how ENBALEX affects you.
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