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Histrelin acetate injection of up to 200 mcg/kg (rats, rabbits), or 2000 mcg/kg (mice) resulted in no systemic toxicity. This represents 20 to 200 times the maximal recommended human dose of 10 mcg/kg/day. Adverse event profiles were similar in patients receiving one, two or four VANTAS implants.
VANTAS is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components in VANTAS. Anaphylactic reactions to synthetic GnRH agonist analogs have been reported in the literature.
VANTAS can cause fetal harm when administered to a pregnant woman. VANTAS is contraindicated in women who are or may become pregnant. Effects on fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The possibility exists that spontaneous abortion may occur. There are no adequate and well-controlled studies in pregnant women. In nonclinical studies, histrelin was teratogenic and fetotoxic. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. [see Use In Specific Populations].
Last reviewed on RxList: 4/22/2013
This monograph has been modified to include the generic and brand name in many instances.
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