LILETTA- levonorgestrel intrauterine device

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Allergan, Inc.

INN (שם בינלאומי):

LEVONORGESTREL

הרכב:

LEVONORGESTREL 52 mg

מסלול נתינה (של תרופות):

INTRAUTERINE

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

LILETTA is indicated for prevention of pregnancy for up to 8 years.  LILETTA is indicated for the treatment of heavy menstrual bleeding for up to 5 years in patients 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. LILETTA is contraindicated when one or more of the following conditions exist: Pregnancy [see Use in Specific Populations ( 8.1 ) ] For use as post-coital contraception (emergency contraception)  Congenital or acquired uterine anomaly, including leiomyomas, that distorts the uterine cavity and would be incompatible with correct IUS placement [see Warnings and Precautions ( 5.10 )] Acute pelvic inflammatory disease (PID) [see Warnings and Precautions ( 5.4 )] Postpartum endometritis or infected abortion in the past 3 months [see Warnings and Precautions ( 5.2 , 5.4 )] Known or suspected uterine or cervical malignancy Known or suspected breast cancer or other hormone-s

leaflet_short:

LILETTA (levonorgestrel-releasing intrauterine system), containing 52 mg levonorgestrel, is supplied partially preloaded within the inserter and packaged in a clear plastic tray with lid. LILETTA is available in a carton of one sterile unit. NDC # 0023-5858-01. LILETTA is supplied sterile. LILETTA is sterilized with ethylene oxide. Do not re-sterilize. Do not use if the packaging is damaged, or if the packaging is opened. Insert before the end of the month shown on the packaging. Store at 20°C – 25°C (68°F – 77°F), with excursions permitted between 15°C – 30°C (59°F – 86°F) [See USP Controlled Room Temperature]. Store the sealed tray with peel-off lid in outer carton until use to protect from light.

מצב אישור:

New Drug Application

מאפייני מוצר

LILETTA- LEVONORGESTREL INTRAUTERINE DEVICE
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LILETTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LILETTA.
LILETTA (LEVONORGESTREL-RELEASING INTRAUTERINE SYSTEM)
INITIAL U.S. APPROVAL: 1968 (NORGESTREL)
RECENT MAJOR CHANGES
Indications and Usage, Heavy Menstrual Bleeding (1.2)06/2023
Dosage and Administration, Dosing Over Time (2.1)
06/2023
Dosage and Administration, Insertion Instructions (2.3)11/2022
Dosage and Administration, Removal of LILETTA (2.6)
06/2023
Contraindications (4)
06/2023
Warnings and Precautions, Expulsion (5.6)
06/2023
INDICATIONS AND USAGE
LILETTA is a progestin-containing intrauterine system indicated for:
Prevention of pregnancy for up to 8 years (1.1)
Treatment of heavy menstrual bleeding for up to 5 years in patients
who choose intrauterine
contraception as their method of contraception (1.2)
DOSAGE AND ADMINISTRATION
The initial release rate of levonorgestrel (LNG) is approximately 20
mcg/day and declines progressively
to approximately 6.5 mcg/day after 8 years; LILETTA can be removed at
any time but must be removed
by the end of the eighth year. (2.1)
To be inserted into the uterine cavity with the provided inserter by a
trained healthcare professional
using strict aseptic technique. Follow insertion instructions exactly
as described. (2.3)
Re-examination and evaluation should be considered 4 to 6 weeks after
insertion and during routine
care, or more often if clinically indicated. (2.5)
DOSAGE FORMS AND STRENGTHS
One intrauterine system consisting of a T-shaped polyethylene frame
with a drug reservoir containing 52
mg LNG, packaged within a sterile inserter. (3)
CONTRAINDICATIONS
Pregnancy (4)
Use for post-coital contraception (emergency contraception) (4)
Congenital or acquired uterine anomaly that distorts the uterine
cavity and would be incompatible with
correct IUS placement (4)
Acute pelvic inflammatory disease (PID) (4)
Postpartum endom