FERRING PHARMACEUTICALS INC.- progesterone ring

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:

MILPROSA™ is indicated to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women up to and including 34 years of age. Limitation of Use Efficacy in women 35 years of age and older has not been established. MILPROSA is contraindicated in women with: - Known sensitivity to progesterone or any of the ingredients of MILPROSA [see Description (11)] - Undiagnosed vaginal bleeding - Severe hepatic impairment or disease - Known or suspected malignancy of the breast - Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events Risk Summary MILPROSA is indicated to support embryo implantation and early pregnancy as part of an assisted reproductive technology treatment program in vitro fertilization (IVF) with or without intracytoplasmic sperm injection (ICSI) and embryo transfer for infertile women. Maternal risks a

Product summary:

Each MILPROSA (progesterone) vaginal system is a white to off-white, flexible, non-biodegradable silicone ring (toroidal-shaped), which contains 1.78 grams of progesterone and releases an average of 11 mg/day of progesterone over a 7-day period of use. MILPROSA vaginal system has an inner and outer diameter of approximately 38 mm and 55 mm, respectively, and a cross-sectional diameter of approximately 8.5 mm. Each MILPROSA is packed individually in a sealed foil pouch. These pouches are available in cartons packed: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze and avoid excessive heat. After use, place in pouch and discard via a drug take-back option if available; otherwise, mix with something undesirable, such as used coffee grounds, dirt, or cat litter to make it less appealing to children and pets. Place the mixture in something that can be closed (a re-sealable zipper storage bag, empty can, or other container) and discard in the household trash. DO NOT flush down toilet. See drug disposal information at www.fda.gov/drugdisposal for more information.

Authorization status:

New Drug Application

Summary of Product characteristics

FERRING PHARMACEUTICALS INC.- PROGESTERONE RING
FERRING PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MILPROSA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MILPROSA.
MILPROSA™ (PROGESTERONE) VAGINAL SYSTEM
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
MILPROSA is a progesterone indicated to support embryo implantation
and early pregnancy (up to 10
weeks post-embryo transfer) 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 MILPROSA is one vaginal system inserted initially on the
day after oocyte retrieval and then
replaced weekly, continuing for up to 10 weeks total duration. (2.1)
DOSAGE FORMS AND STRENGTHS
Vaginal system: 1.78 grams of progesterone in a white to off-white,
flexible, non-biodegradable silicone
ring (toroidal-shape). Releases an average of 11 mg/day progesterone
over 7 days. (3)
CONTRAINDICATIONS
Previous allergic reactions to progesterone or any of the ingredients
of MILPROSA (4)
Undiagnosed vaginal bleeding (4)
Severe hepatic impairment or disease (4)
Known or suspected malignancy of the breast (4)
Active arterial or venous thromboembolism or severe thrombophlebitis,
or a history of these events (4)
WARNINGS AND PRECAUTIONS
Arterial and venous thromboembolic disorders may occur with use of
MILPROSA. Discontinue MILPROSA
and initiate appropriate treatment measures if any of these are
suspected. (5.1)
Discontinue MILPROSA use if symptoms worsen in a woman with a history
of depression. (5.2)
Discontinue MILPROSA use and initiate appropriate treatment measures
for women suspected of
having toxic shock syndrome based on signs and symptoms including
fever, nausea, vomiting,
diarrhea, muscle pain, dizziness, faintness or a sunburn-like rash on
the face and body. (5.3)
Avoid the use of MILPROSA with other vaginal products (such as
antifungal products, vaginal lubri