ENDOMETRIN- progesterone insert

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)

Available from:

Ferring Pharmaceuticals Inc.

Administration route:

VAGINAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 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 ENDOMETRIN has been used to support embryo implantation and maintain clinical pregnancy in one clinical study. The live birth outcomes of these pregnancies were as follows: - Among the 404 subjects treated with ENDOMETRIN twice daily, 143 subjects had live births consisting of 85 singletons, 56 twins, and 2 triplets. In this treatment group, 1

Product summary:

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: Store at 20 - 25°C (68 - 77°F); excursions permitted between 15 - 30°C (59 - 86°F). MANUFACTURED FOR: FERRING PHARMACEUTICALS INC. PARSIPPANY, NJ 07054 6485-03 Revised: 01/2018

Authorization status:

New Drug Application

Summary of Product characteristics

ENDOMETRIN- PROGESTERONE INSERT
FERRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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 retrieval 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
100 mg vaginal insert (3)
CONTRAINDICATIONS
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)
ADVERSE REACTIONS
The most common adverse reactions reported (greater than 2%) were
post-oocyte retrieval pain,
abdominal pain, nausea, and ovarian hyper