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Factrel

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Factrel

Warnings
Precautions

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 (gonadorelin) , to date no such reactions have been reported following the administration of a single 100 mcg dose of Factrel (gonadorelin) .

Antibody formation has been reported rarely after chronic administration of large doses of Factrel (gonadorelin) .

 

B.  Drug Interactions

The Factrel (gonadorelin) 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 (gonadorelin) 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 (gonadorelin) 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 (gonadorelin) . 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 (gonadorelin) is administered to a nursing woman.

Pediatric Use:   Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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