Important: For vaginal use only
For full Prescribing Information, see package insert. A brief summary follows.
INDICATIONS AND USAGE: Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of cor- pus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
CONTRAINDICATIONS:
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 • 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
WARNINGS: Cardiovascular or Cerebrovascular Disorders
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.
Depression Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
Use of Other Vaginal Products
Endometrin not recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.
PRECAUTIONS: Pregnancy: Endometrin has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The livebirth outcomes of these pregnancies were as follows: Among the 404 subjects treated with Endometrin twice daily, 143 subjects had livebirths consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 13 subjects had a spontaneous abortion, 1 subject had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.4% based on 203 livebirths).
Among the 404 subjects treated with Endometrin three times daily, 155 subjects had livebirths consist- ing of 91 singletons, 60 twins, and 4 triplets. In this treatment group, 22 subjects had a spontaneous abortion, 4 subjects had an ectopic pregnancy, and 7 subjects reported fetal birth defects (3.1% based on 223 livebirths).
Birth defects reported in the Endometrin twice daily group included: one fetus with a cleft palate and intrauterine growth retardation, one fetus with spina bifida, three fetuses with congenital heart defects, one fetus with an umbilical hernia, and one fetus with an intestinal anomaly. Birth defects reported in the Endometrin three times daily group included: one fetus with an esophageal fistula, one fetus with hypospadias and an underdeveloped right ear, one fetus with Down’s and an atrial septal defect, one fetus with congenital heart anomalies, one fetus with DiGeorge’s syndrome, one fetus with a hand deformity, and one fetus with cleft palate. Nursing Mothers: Detectable amounts of progesterone have been identified in the milk of nursing moth- ers. The effect of this on the nursing infant has not been determined. Pediatric Use: This drug is not intended for pediatric use and no clinical data have been collected in children.
Geriatric Use: No clinical data have been collected in patients over age 65.
ADVERSE REACTIONS: Clinical Studies Experience The safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5.0% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are listed as follows:
Endometrin, 100 mg two times daily (N=404)
Gastrointestinal Disorders: Abdominal pain 50 (12%), Nausea 32 (8%), Abdominal distension 18 (4%), Constipation 9 (2%), Vomiting 13 (3%). General Disorders and Administration Site Reactions: Fatigue 7 (2%). Infections and Infestations: Urinary tract infection 9 (2%). Injury, Poisoning and Procedural Compli- cations: Post-oocyte retrieval pain 115 (28%). Nervous System Disorders: Headache 15 (4%). Reproduc- tive System and Breast Disorders: Ovarian hyperstimulation syndrome 30 (7%), Uterine spasm 15 (4%), Vaginal bleeding 13 (3%).
Endometrin, 100 mg three times daily (N=404)
Gastrointestinal Disorders: Abdominal pain 50 (12%), Nausea 29 (7%), Abdominal distension 17 (4%), Constipation 14 (3%), Vomiting 9 (2%). General Disorders and Administration Site Reactions: Fatigue 12 (3%). Infections and Infestations: Urinary tract infection 4 (1%). Injury, Poisoning and Procedural Compli- cations: Post-oocyte retrieval pain 102 (25%). Nervous System Disorders: Headache 13 (3%). Reproduc- tive System and Breast Disorders: Ovarian hyperstimulation syndrome 27 (7%), Uterine spasm 11 (3%), Vaginal bleeding 13 (3%).
Expected Adverse Reaction Profile Seen with Progesterone Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
OVERDOSAGE: Treatment of overdosage consists of discontinuation of Endometrin together with institu- tion of appropriate symptomatic and supportive care.
CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Nonclinical toxicity studies to determine the potential of Endometrin to cause carcinogenicity or muta- genicity have not been performed. The effect of Endometrin on fertility has not been evaluated in animals.
HOW SUPPLIED/STORAGE AND HANDLING: Each Endometrin Vaginal Insert is a white to off-white oblong-shaped insert debossed with “FPI” on one side and “100” on the other side. Each Endometrin® (progesterone) Vaginal Insert, 100 mg, is packed individually in a sealed foil pouch. These pouches are available in cartons packed: 21 vaginal inserts with 21 disposable vaginal applicators (NDC 55566-6500-3) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Rx only
Manufactured by: Pharmaceutics International Inc., Hunt Valley, MD 21031
Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 6323-01
For more information, go to
www.endometrin.com.
©2010 Ferring Pharmaceuticals Inc.
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