*In a nationwide survey of fertility patients undergoing ART May 2008 through August 2008, ENDOMETRIN® was preferred by: 88% of patients (n=154) who had used both ENDOMETRIN® and progesterone-in-oil injections; 88% of patients (n=83) who had used ENDOMETRIN® and progesterone suppositories; and 69% of patients (n=26) who used both ENDOMETRIN® and Crinone®/Prochieve® gel.
†Analysis of efficacy population. TID dosing group (n=390).
Crinone® and Prochieve® are registered trademarks of Columbia Laboratories, Inc.
ENDOMETRIN® administered as a 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 for infertile women.
MENOPUR® administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program. BRAVELLE® administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) during ART cycles in patients who have previously received pituitary suppression. BRAVELLE® administered SC or IM, in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression.
Important Safety Information
Only physicians thoroughly familiar with infertility treatment should prescribe ENDOMETRIN®. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2% included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than 2%. ENDOMETRIN® is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness). ENDOMETRIN® is contraindicated in womem who have or have had previous allergic reactions to progesterone or any of the ingredients in ENDOMETRIN®; a 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.
Only physicians thoroughly familiar with infertility treatment, including the risk of multiple births and adverse reactions, should prescribe BRAVELLE® and MENOPUR®. BRAVELLE® and MENOPUR®, like all gonadotropins, are potent substances capable of causing mild to severe adverse reactions, including OHSS (overall incidence of 6.0% for BRAVELLE® and 3.8% for MENOPUR®), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. BRAVELLE® and MENOPUR® are contraindicated in women who have a high FSH level indicating primary ovarian failure; uncontrolled thyroid and adrenal dysfunction; an organic intracranial lesion such as a pituitary tumor; abnormal uterine bleeding of undetermined origin; ovarian cysts or enlargement not due to polycystic ovary syndrome; prior hypersensitivity to respectively, urofollitropins, purified, and menotropins or MENOPUR®. BRAVELLE® is contraindicated for the presence of any cause of infertility other than anovulation. MENOPUR® is contraindicated for sex hormone dependent tumors of the reproductive tract and accessory organs. BRAVELLE® and MENOPUR® are contraindicated in women who are pregnant. BRAVELLE® may cause fetal harm when administered to a pregnant woman. There are limited human data on the effects of BRAVELLE® and menotropins when administered during pregnancy.
REFERENCES: 1. Doody KJ, Schnell VL, Foulk RA, et al. Endometrin for luteal phase support in a randomized, controlled, open-label, prospective in-vitro fertilization trial using a combination of Menopur and Bravelle for controlled ovarian hyperstimulation. Fertil Steril. 2009;91:1012-1017. 2. ENDOMETRIN® [prescribing information]. Parsippany, NJ: Ferring Pharmaceuticals Inc; June 2007. 3. Data on file. Ferring Pharmaceuticals Inc. 4. Khan N, Richter KS, Newsome TL, et al. Matched-samples comparison of intramuscular versus vaginal progesterone for luteal phase support after in vitro fertilization and embryo transfer. Fertil Steril. 2008 June 12. [epub ahead of print]
5. Mitwally MF, Diamond MP, Abuzeid M. Vaginal micronized progesterone versus intramuscular progesterone for luteal support in women undergoing in vitro fertilization-embryo transfer. Fertil Steril. 2009 April 9. [epub ahead of print] 6. Beltsos AN, Elgar C, Robertson A, et al. Luteal phase support with Endometrin vs progesterone in oil in in vitro fertilization cycles. Presented at: 64th Annual Meeting of the American Society for Reproductive Medicine; November 8-12, 2008; San Francisco, CA. 7. Progesterone Supplementation: Evaluation of Attitudes and Satisfaction with Endometrin (EASE). Results of an Online Patient Survey. Parsippany, NJ: Ferring Pharmaceuticals Inc.; 2008. 8. Doody K, Shamma FN, Paulson RJ, et al. Endometrin® for luteal phase support in a randomized, controlled, open-label prospective IVF clinical trial using a combination of Menopur® and Bravelle®. Presented at: PCRS Annual Meeting; April 18-22, 2007; Rancho Mirage, CA. 9. Schnell VL, Zbella E, Hummel WP, et al. Evaluation of QD vs. BID dosing of gonadotropins in patients undergoing IVF. Presented at: 55th Annual Meeting of the Pacific Coast Reproductive Society; April 18-22, 2007; Rancho Mirage, CA. 10. Schoolcraft W, Miller C, Check JH, et al. Endometrin® for luteal phase support in a randomized, controlled, open-label, prospective IVF clinical trial using a combination of Menopur® and Bravelle®: comparison by age, BMI and basal FSH. Presented at: 55th Annual Meeting of the Pacific Coast Reproductive Society; April 18-22, 2007; Rancho Mirage, CA. 11. Khan N, Richter KS, Blake EJ, Yankov VI. Case-matched comparison of intramuscular versus vaginal progesterone for luteal phase support after in vitro fertilization and embryo transfer. Presented at: 55th Annual Meeting of the Pacific Coast Reproductive Society; April 18-22, 2007; Rancho Mirage, CA. 12. Blake EJ, Norris PM, Yankov VI. A randomized, open-label, single and multidose (single-day and multiple-day) pharmacokinetic study of a vaginal micronized progesterone tablet (Endometrin®) compared to Crinone® 8% vaginal gel in healthy reproductive-age female subjects. Presented at: 54th Annual Scientific Meeting of the Society for Gynecologic Investigation; March 16, 2007; Reno, NV.
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Age: 18 to 42 years
