These highlights do not include all the information needed to use Endometrin safely and effectively.
See full prescribing information for Endometrin.
ENDOMETRIN ® (progesterone)
Vaginal Insert 100 mg
Initial U.S. Approval: 2007
INDICATIONS AND USAGE
Endometrin® is a progesterone 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. (1)
DOSAGE AND ADMINISTRATION
The dose of Endometrin is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieva l and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of Endometrin in this age group has not been determined. (2.1)
DOSAGE FORMS AND STRENGTHS
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100 mg vaginal insert (3)
CONTRAINDICATIONS
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Previous allergic reactions to progesterone or any of the ingredients of Endometrin Vaginal Insert (4)
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Known missed abortion or ectopic pregnancy (4)
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Liver disease (4)
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Known or suspected breast cancer (4)
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Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events (4)
WARNINGS AND PRECAUTIONS
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Life-threatening arterial or venous thromboembolic disorders may occur during hormone treatment, including treatment with Endometrin. Discontinue Endometrin if any of these are suspected (5.1)
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Observe patients with a history of depression closely. Consider discontinuation if symptoms worsen (5.2)
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Endometrin is not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert (5.3)
ADVERSE REACTIONS
The most common adverse reactions reported (greater than 2%) were post-oocyte retrieva l pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome. (6)
This leaflet summarizes the most important information about Endometrin. To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 10/2012
