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MENOPUR® (menotropins for injection)
Indication for Use
- 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
- 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
- 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.
- 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.
NOVAREL® (chorionic gonadotropin for injection, USP)
Indication for Use
- NOVAREL is indicated for the induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pre-treated with human menotropins.
Important Safety Information
- NOVAREL should not be used in patients with prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman.
- NOVAREL should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions during this use are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion; (2) Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum; (3) Multiple births, and (4) Arterial thromboembolism.
- Anaphylaxis has been reported with urinary-derived HCG products.
- Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
- HCG can cross react in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of cross reactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.
- Defects of forelimbs and of the central nervous system, as well as alterations in sex ratio, have been reported in mice on combined gonadotropin and HCG regimens. The dose of gonadotropin used was intended to induce superovulation. No mutagenic effect has been clearly established in humans.
- 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 HCG is administered to a nursing woman.
- Adverse reactions include headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.
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.
ENDOMETRIN® (progesterone) Vaginal Insert
Indication for Use
- ENDOMETRIN® (progesterone) Vaginal Insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Important Safety Information
- ENDOMETRIN should not be used in individuals with any of the following conditions: previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN, undiagnosed vaginal bleeding, known missed abortion or ectopic pregnancy, liver disease, known or suspected breast cancer, active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
- The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. ENDOMETRIN should be discontinued if any of these are suspected.
- Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
- ENDOMETRIN should not be recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.
- The most common adverse reactions reported (greater than 5%) were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome.
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.