MENOPUR® (menotropins for injection)
INDICATION FOR USE
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MENOPUR® (menotropins for injection), administered subcutaneously, is
indicated for the development of multiple follicles and pregnancy in the
ovulatory patients participating in an Assisted Reproductive Technology
(ART) program.
IMPORTANT SAFETY INFORMATION
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MENOPUR is contraindicated in women who have: a high FSH level
indicating primary ovarian failure, presence of uncontrolled non-gonadal
endocrinopathies, tumors of the pituitary gland or hypothalamus, sex
hormone dependent tumors of the reproductive tract and accessory organs,
abnormal uterine bleeding of undetermined origin, ovarian cysts or
enlargement of undetermined origin, not due to polycystic ovary
syndrome, or prior hypersensitivity to menotropins or MENOPUR. MENOPUR
is not indicated in women who are pregnant and may cause fetal harm when
administered to a pregnant woman
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MENOPUR should only be used by physicians who are thoroughly familiar
with infertility problems. MENOPUR is a potent gonadotropic substance
capable of causing Ovarian Hyperstimulation Syndrome (OHSS), with or
without pulmonary or vascular complications, in women undergoing therapy
for infertility. Ovarian torsion has been reported after gonadotropin
treatment. Serious pulmonary conditions and thromboembolic events have
been reported with MENOPUR. There have been infrequent reports of
ovarian neoplasms with MENOPUR. Multiple pregnancies, spontaneous
abortion, congenital malformations and ectopic pregnancies have occurred
following treatment with MENOPUR.
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The most common adverse reactions (≥2%) in ART include: abdominal
cramps; abdomen enlarged; abdominal pain; headache; injection site pain
and reaction; injection site inflammation; OHSS.
You are encouraged to report negative side effects of prescription drugs
to FDA. Visit www.FDA.gov/medwatch, or call 1.800.FDA.1088.
Please see full Prescribing Information.
