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
Factrel Warnings, Precautions, Pregnancy, Nursing, Abuse - gonadorelin
Factrel Warnings, Precautions, Pregnancy, Nursing, Abuse - gonadorelin
WARNINGS
No Information Provided.
PRECAUTIONS
A. General
Although allergic and hypersensitivity reactions have been observed with other
polypeptide hormones, and rarely with multiple doses of Factrel, to date no
such reactions have been reported following the administration of a single 100
mcg dose of Factrel.
Antibody formation has been reported rarely after chronic administration of
large doses of Factrel.
B. Drug Interactions
The Factrel test should be conducted in the absence of other drugs which directly
affect the pituitary secretion of the gonadotropins. These would include a variety
of preparations which contain androgens, estrogens, progestins, or glucocorticoids.
The gonadotropin levels may be transiently elevated by spironolactone, minimally
elevated by levodopa, and suppressed by oral contraceptives and digoxin. The
response to Factrel may be blunted by phenothiazines and dopamine antagonists
which cause a rise in prolactin.
C. Carcinogenesis, Mutagenesis, Impairment of Fertility
Repetitive, high doses of Factrel may cause luteolysis and inhibition of spermatogenesis.
No long-term animal studies have been done to evaluate carcinogenic potential.
D. Pregnancy Category B
Reproduction studies have been performed in mice, rats, and rabbits at doses
up to 50 times the human dose, and have revealed no evidence of harm to the
fetus due to Factrel. There are, however, no adequate and well-controlled studies
in pregnant women. Because animal reproduction studies are not always predictive
of human response, this drug should be used during pregnancy only if clearly
needed.
Appropriate precautions should be taken because the effects of LH-RH on the
fetus and developing offspring have not been adequately evaluated.
Nursing Mothers: It is not known whether this drug is excreted
in human milk. Because many drugs are excreted in human milk, caution should
be exercised when Factrel is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients
have not been established.
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