MIRENA- levonorgestrel intrauterine device

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 52 mg

Administration route:

INTRAUTERINE

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Mirena is indicated for prevention of pregnancy for up to 8 years; replace after the end of the eighth year. Mirena is indicated for the treatment of heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as their method of contraception; replace after the end of the fifth year if continued treatment of heavy menstrual bleeding is needed. The use of Mirena is contraindicated when one or more of the following conditions exist: The use of Mirena is contraindicated in pregnancy or with a suspected pregnancy and Mirena may cause adverse pregnancy outcomes [see Contraindications (4 ), Warnings and Precautions (5.1 , 5.2 )]. If a woman becomes pregnant with Mirena in place, the likelihood of ectopic pregnancy is increased and there is an increased risk of miscarriage, sepsis, premature labor, and premature delivery. Remove Mirena, if possible, if pregnancy occurs in a woman using Mirena. If Mirena cannot be removed, follow the pregnancy closely [see Warnings and Precautio

Product summary:

Mirena (levonorgestrel-releasing intrauterine system), containing a total of 52 mg LNG, is available in a carton of one sterile unit NDC# 50419-423-01. Mirena is supplied sterile. Mirena is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the end of the month shown on the label. Store at 25°C (77°F); with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Summary of Product characteristics

MIRENA- LEVONORGESTREL INTRAUTERINE DEVICE
BAYER HEALTHCARE PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIRENA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIRENA.
MIRENA (LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM)
INITIAL U.S. APPROVAL: 2000
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Mirena is a progestin-containing intrauterine system (IUS) indicated
for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Indications and Usage, Contraception (1.1) 8/2022
Prevention of pregnancy for up to 8 years (1.1)
Treatment of heavy menstrual bleeding for women who choose to use
intrauterine contraception as
their method of contraception for up to 5 years. (1.2)
Release rate of levonorgestrel (LNG) is 21 mcg/day after 24 days; this
rate is reduced to about 11
mcg/day after 5 years and 7 mcg/day after 8 years. (2.1)
To be inserted by a trained healthcare provider using strict aseptic
technique. Follow insertion
instructions exactly as described. (2.2)
Patient should be re-examined and evaluated 4 to 6 weeks after
insertion; then, yearly or more often
if clinically indicated. (2.3)
One sterile intrauterine system consisting of a T-shaped polyethylene
frame with a steroid reservoir
containing 52 mg levonorgestrel packaged within a sterile inserter (3)
Pregnancy or suspicion of pregnancy. Cannot be used for post-coital
contraception (emergency
contraception) (4).
Congenital or acquired uterine anomaly if it distorts the uterine
cavity (4)
Acute pelvic inflammatory disease (PID) or a history of PID unless
there has been a subsequent
intrauterine pregnancy (4)
Postpartum endometritis or infected abortion in the past 3 months (4)
Known or suspected uterine or cervical malignancy (4)
Known or suspected breast cancer or other progestin-sensitive cancer
(4)
Uterine bleeding of unknown etiology