Progesterone

Endometrin

Approved 21 Jun 2007VaginalInsert

Indications

ENDOMETRIN ® (progesterone) 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. 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)

Contraindications

ENDOMETRIN is contraindicated in individuals with any of the following conditions: Previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN [ see Description (11) ] Undiagnosed vaginal bleeding Known missed abortion or ectopic pregnancy Liver disease Known or suspected malignancy of the breast or genital organs Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN Vaginal Insert (4) Undiagnosed vaginal bleeding ( 4 ) Known missed abortion or ectopic pregnancy (4) Liver disease (4) Known or suspected malignancy of the breast or genital organs (4) Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events (4)

Warnings and precautions

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 ) Observe patients with a history of depression closely. Consider discontinuation if symptoms worsen. ( 5.2 ) 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 )

5.1Cardiovascular 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.

5.2 Depression Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.

At a glance

Brand name: Endometrin
Active substance: progesterone
Pharmacologic class: Progesterone
Route: Vaginal
Dosage form: Insert
Applicant: Ferring
Status: Prescription
FDA approval: 21 Jun 2007
Application: NDA022057-001

Indications

(1)

Contraindications

Warnings and precautions

( 5.3 )

5.1Cardiovascular or Cerebrovascular Disorders

5.2 Depression Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.

Adverse reactions

The most common adverse reactions reported (greater than 2%) were post-oocyte retrieval 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 Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data reflect exposure to ENDOMETRIN in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% 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 summarized in Table 1. Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with ENDOMETRIN in an Assisted Reproductive Technology Study Body System ENDOMETRIN 100 mg twice daily (N=404) ENDOMETRIN 100 mg three times daily (N=404) Preferred Term Gastrointestinal Disorders Abdominal pain 50 (12%) 50 (12%) Nausea 32 (8%) 29 (7%) Abdominal distension 18 (4%) 17 (4%) Constipation 9 (2%) 14 (3%) Vomiting 13 (3%) 9 (2%) General Disorders and Administration Site Conditions Fatigue 7 (2%) 12 (3%) Infections and Infestations Urinary tract infection 9 (2%) 4 (1%) Injury, Poisoning and Procedural Complications Post-oocyte retrieval pain 115 (28%) 102 (25%) Nervous System Disorders Headache 15 (4%) 13 (3%) Reproductive System and Breast Disorders Ovarian hyperstimulation syndrome 30 (7%) 27 (7%) Uterine spasm 15 (4%) 11 (3%) Vaginal bleeding 13 (3%) 14 (3%) Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.

6.2Expected 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.

Endometrin

Indications

Contraindications

Warnings and precautions

5.1Cardiovascular or Cerebrovascular Disorders

At a glance

Two medicines in one question?

Endometrin

Indications

Contraindications

Warnings and precautions

5.1Cardiovascular or Cerebrovascular Disorders

At a glance

Two medicines in one question?

5.3Use of Other Vaginal Products

Interactions

Pregnancy and breastfeeding

8.1Pregnancy

Adverse reactions

6.1Clinical Studies Experience

6.2Expected Adverse Reaction Profile Seen with Progesterone

Composition

Official product information