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
Teslascan Side Effects, and Drug Interactions - Mangafodipir
Teslascan Side Effects, and Drug Interactions - Mangafodipir
SIDE EFFECTS
In clinical trials, a total of 637 subjects (57 healthy volunteers
and 580 patients) with known or suspected liver lesions received the contrast
agent at a dose of 5 µmol/kg. Of these subjects, there were 387 men and
250 women with a mean age of 56 years (19 to 86).There were 497 (78%) Caucasian,
72 (11%) Black, 32 (5%) Oriental, and 36 (6%) in other racial groups.
Of these 637 subjects, 481 (76%) reported at least one adverse
event.In clinical trials, there were 4 deaths and 2 serious events. The serious
events included prolonged vomiting in one patient. The deaths occurred in patients
with advanced multisystem disease (hepatocellular carcinoma, esophageal variceal
bleeding, sepsis, and pneumonia) and were attributed to the underlying disorders.
The most commonly noted adverse experiences were injection
site discomfort 430 (67%), headache - 32 (5%), and any gastrointestinal event
- 79 (12%).(See Table 5 for details.)
|
TABLE 5 ADVERSE EVENTS REPORTED IN >0.5% OF PATIENTS
WHO RECEIVED TESLASCAN IN CLINICAL TRIALS
|
|
Patients Exposed to TESLASCAN
|
637
|
|
Patients with Any Adverse Event
|
481 (76%)
|
|
Patients with Any Injection Site
|
430 (67%)
|
|
Discomfort
|
|
|
Gastrointestinal
|
79 (12%)
|
|
Nausea
|
67 (11%)
|
|
Vomiting
|
17 (3%)
|
|
Abdominal Pain
|
14 (2%)
|
|
Body as a Whole
|
25 (4%)
|
|
Headache
|
32 (5%)
|
|
Chest Pain
|
4 (0.6%)
|
|
Central & Peripheral Nervous
|
48 (8%)
|
|
System
|
|
|
Dizziness
|
9 (1%)
|
|
Skin & Appendages
|
12 (2%)
|
|
Pruritus
|
7 (1%)
|
As with other contrast media, patients receiving TESLASCAN
reported injection-associated discomfort. Overall 430 (67%) of the patients
receiving TESLASCAN reported mild to moderate injection-associated discomfort.
Of these, the discomfort was described as heat 266 (42%), flushing 234 (36%),
pressure 26 (4%), pain 19 (3%), and cold 9 (1%).
The following selected adverse events occurred in <0.5%
of the subjects. The majority (93%) of these adverse events were of mild to
moderate intensity:chest pain, dizziness, hot flushes, hypersensitivity, hypertension,
palpitation, pruritus, rash, taste perversion, urticaria.
In another 798 subjects who received the contrast agent in
foreign clinical trials, similar types and rates of adverse events were reported.
DRUG INTERACTIONS
Drug interactions with other contrast agents and other drugs
were not studied.
LABORATORY TEST INTERACTIONS
Transmetalation of manganese may occur.The extent to which
this might affect laboratory assays of ferritin, iron, bilirubin, and zinc is
not known.
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