A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Miraluma Side Effects, and Drug Interactions - Technetium Tc99m sestamibi
Miraluma Side Effects, and Drug Interactions - Technetium Tc99m sestamibi
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 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%)
|
|
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, 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.
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