Levonorgestrel (Liletta)

Trade Name : LILETTA

Allergan, Inc.

INTRAUTERINE DEVICE

Strength 52 mg/1

LEVONORGESTREL Inhibit Ovum Fertilization [PE],Progesterone Congeners [CS],Progesterone Congeners [CS],Progestin [EPC],Progestin-containing Intrauterine Device [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Levonorgestrel (Liletta) which is also known as LILETTA and Manufactured by Allergan, Inc.. It is available in strength of 52 mg/1 per ml. Read more

Levonorgestrel (Liletta) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Indications and Usagenttu00a0u00a0u00a0u00a0u00a0ntu00a0()nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt10/2019
  • Dosage and Administration, Dosing Over Timeu00a0()nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt10/2019
  • LILETTA is indicated for prevention of pregnancy for up to 6u00a0years.u00a0
  • LILETTAu00a0is a progestin-containing intrauterine system indicated for prevention of pregnancy for up to 6u00a0years. ()
  • No data
  • The initial release rate of levonorgestrel (LNG) is approximately 20 mcg/day and declines progressively to approximately 8.6 mcg/day after 6 years; LILETTA can be removed at any time but must be removed by the end of the sixth year. ()n
  • 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. ()n
  • Patients should be re-examined and evaluated 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. ()
  • LILETTA is a levonorgestrel-releasing intrauterine system consisting of a T-shaped polyethylene frame with a drug reservoir containing 52 mg levonorgestrel, packaged within a sterile inserter.
  • One intrauterine system consisting of a T-shaped polyethylene frame with a drug reservoir containing 52 mg LNG, packaged within a sterile inserter. ()
  • LILETTA is contraindicated when one or more of the following conditions exist:
  • Pregnancy ()u00a0n
  • Use for post-coital contraception (emergency contraception) ()n
  • Congenital or acquired uterine anomaly that distorts the uterine cavity andu00a0would be incompatible with correct IUS placement ()n
  • Acute pelvic inflammatory disease (PID) or endometritisu00a0or a history of PID unless there has been a subsequent intrauterine pregnancy ()n
  • Infected abortion in the past 3 months ()n
  • Known or suspected uterine or cervical neoplasiau00a0()n
  • Known or suspected breast cancer or other hormone-sensitive cancer ()n
  • Uterine bleeding of unknown etiology ()n
  • Untreated acute cervicitis or vaginitisu00a0or other lower genital tract infections ()n
  • Acute liver disease or liver tumor (benign or malignant) ()n
  • Increased susceptibility to pelvic infections ()n
  • A previously inserted IUS that has not been removed ()n
  • Hypersensitivity to any component of LILETTA ()
  • No data
  • Remove LILETTA if pregnancy occurs with LILETTA in place and LILETTA is in the uterus. If pregnancy occurs, there is increased risk of ectopic pregnancy (including loss of fertility), pregnancy loss, septic abortion (including septicemia, shock and death) and premature labor and delivery. (, ) n
  • Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of LNG-releasing IUSs; strict aseptic technique is essential during insertion. () n
  • Before using LILETTA, consider the risks of pelvic infection. () n
  • Perforation may occur and reduce contraceptive effectiveness. Risk is increased if inserted in women with fixed retroverted uteri, during lactation, or postpartum. () n
  • Partial or complete expulsion may occur. ()n
  • Evaluate persistent enlarged ovarian follicles or ovarian cysts. ()n
  • Bleeding patterns can become altered, may remain irregular, and amenorrhea may ensue. ()
  • The following serious or important adverse reactions are discussed elsewhere in the labeling:
  • The most common adverse reactions reported in clinical trials (> 10% users) are vulvovaginal mycotic infections, vaginal bacterial infections, acne, and nausea or vomiting. ()
  • No drug-drug interaction studies have been conducted with LILETTA.
  • No data
  • No data
  • No data
  • No data
  • LILETTA was studied in a multicenter, randomized, open-label clinical trial conducted in the US that enrolled 1,910u00a0generally healthy women aged 16 to 45 years, 1,751 of whom received LILETTA. u00a0LILETTAu00a0was inserted in 1,011 (58%) nulliparous and 740 (42%) parous women. Women with a history of ectopic pregnancy, PID, or trophoblastic disease without a subsequent intrauterine pregnancy, who were less than 4 weeks post-pregnancy, had HIV, or were not in a mutually monogamous relationship at study entry were excluded. The demographic profile of enrolled women who received LILETTAu00a0are as follows: Caucasian 78.4%, Black or African American 13.3%, Asian 3.9%, American Indian or Alaska Native 1.2%, Native Hawaiian or Other Pacific Islander 0.3%; 2.9% identified multiple races; 14.7% indicated Hispanic ethnicity. The clinical trial had no upper or lower weight or BMI limit and the BMI range was 15.8u00a0u2013 61.6 kg/m.u00a0The mean BMI of LILETTA subjects was 26.9u00a0kg/m; 24% were overweight, 24% were obeseu00a0(BMI u2265 30 kg/m), and 5% were morbidly obese (BMI u2265 40 kg/m).
  • The pregnancy rate calculated as the Pearl Index (PI) in women aged 16 to 35 years, inclusive, was the primary efficacy endpoint used to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; evaluable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. The Year 1 PI was based on two pregnancies and the cumulative 6-year pregnancy rate was calculated by the life table method, based on a total of nine pregnancies that occurred after the onset of treatment and within 7 days after LILETTA removal or expulsion.u00a0Table 5 shows the annual PI for each of the six years and the calculated cumulative life tableu00a0pregnancy rates through years 1, 2, 3, 4, 5, and 6.u00a0
  • Conception rates after the removal of LILETTA were assessed and appeared consistent with conception rates in the general population of women having regular unprotected sexual intercourse for 12 months.
  • Of 191 women who desired pregnancy after study discontinuation, 79% conceived within 6 months after removal ofu00a0LILETTA, and 85%u00a0conceived within 12 months after removal of LILETTAn
  • nttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0nt(1) nttu00a0u00a0u00a0u00a0u00a0ntCenters for Disease Control and Prevention (CDC), (2019). CDC-STD Treatment [online] Available at: https://www.cdc.gov/std/treatment/default.htm
  • 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 20u00b0C u2013 25u00b0C (68u00b0F u2013 77u00b0F), with excursions permitted between 15u00b0C u2013 30u00b0C (59u00b0F u2013 86u00b0F) [See USP Controlled Room Temperature]. Store the sealed tray with peel-off lidu00a0in outer carton until use to protect from light.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Complete the Follow-Up Reminder Card and give it to the patient.
  • LILETTAn- Arrayn- u00a0and its design are registered trademarks of Odyssea Pharma SPRL, an Allergan affiliate.
  • Odyssea Pharma, SPRL,u00a0Belgium
  • An affiliated company ofu00a0Allergan USA, Inc.
  • Distributed by:
  • Allergan USA, Inc. Irvine, CAu00a092612
  • Marketed by:
  • Allergan USA, Inc.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Medicines360
  • Irvine, CA u00a0u00a092612u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0San Francisco, CA 94111
  • u00a9 201n- 9n- Allergan and Medicines360. u00a0All rights reserved.n- u00a0
  • V1.0USPI5858
  • u00a0n- This Patient Information has been approved by the U.S. Food and Drug Administration n- 10/2019
  • V1.0n- Pn- PI5858
  • NDC 0023-5858-01n n Liletta(levonorgestrel-releasing intrauterine system) n

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