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
Thyrogen Warnings, Precautions, Pregnancy, Nursing, Abuse - Thyrotropin Alfa
Thyrogen Warnings, Precautions, Pregnancy, Nursing, Abuse - Thyrotropin Alfa
WARNINGS
No Information Provided.
PRECAUTIONS
(see INDICATIONS AND USAGE, Considerations in the Use of Thyrogen )
General
The use of Thyrogen (thyrotropin alfa for injection) should be directed by
physicians knowledgeable in the management of patients with thyroid cancer.
Thyroglobulin (Tg) antibodies may confound the Tg assay and render Tg levels
uninterpretable. Therefore, in such cases, even with a negative or low-stage
Thyrogen radioiodine scan, consideration should be given to evaluating patients
further with, for example, a confirmatory thyroid hormone withdrawal scan to
determine the location and extent of thyroid cancer.
Thyrogen should be administered intramuscularly only. It should not be administered
intravenously.
TSH antibodies have not been reported in patients treated with Thyrogen in
the clinical trials, although only 27 patients received Thyrogen on more than
one occasion.
Caution should be exercised when Thyrogen is administered to patients who have
been previously treated with bovine TSH and, in particular, to those patients
who have experienced hypersensitivity reactions to bovine TSH.
Thyrogen is known to cause a transient but significant rise in serum thyroid
hormone concentration. Therefore, caution should be exercised in patients with
a known history of heart disease and with significant residual thyroid tissue
(see ADVERSE REACTIONS).
Drug-Drug Interactions
Formal interaction studies between Thyrogen and other medicinal products have
not been performed. In clinical trials, no interactions were observed between
Thyrogen and the thyroid hormones triiodothyronine (T 3 ) and thyroxine
(T 4 ) when administered concurrently.
The use of Thyrogen allows for radioiodine imaging while patients are euthyroid
on triiodothyronine (T 3 ) and/or thyroxine (T 4 ). Data
on radioiodine 131 l kinetics indicate that the clearance of radioiodine
is approximately 50% greater in euthyroid patients than in hypothyroid patients,
who have decreased renal function. Thus radioiodine retention is less in euthyroid
patients at the time of imaging and this factor should be considered when selecting
the activity of radioiodine for use in radioiodine imaging.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term toxicity studies in animals have not been performed with Thyrogen
to evaluate the carcinogenic potential of the drug. Thyrogen was not mutagenic
in the bacterial reverse mutation assay. Studies have not been performed with
Thyrogen to evaluate the effects on fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with Thyrogen.
It is also not known whether Thyrogen can cause fetal harm when administered
to a pregnant woman or can affect reproductive capacity. Thyrogen should be
given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether the drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when Thyrogen is administered
to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 16 years have
not been established.
Geriatric Use
Results from controlled trials indicate no difference in the safety and efficacy
of Thyrogen between adult patients less than 65 years and those greater than
65 years of age.
top
