Emily is a Levonorgestrel releasing Intrauterine System indicated for Intrauterine contraception for up to 5 years and for the treatment of heavy menstrual bleeding.

 

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About EMILY (Levonorgestrel releasing Intrauterine System)

BRIEF PRESCRIBING INFORMATION

This information does not include all details needed to use Emily safely and effectively. See full prescribing information for Emily. Emily (Levonorgestrel releasing Intrauterine System) Approval date (India): 2011 -Full Prescribing Information

INDICATIONS

Emily is a sterile, Levonorgestrel releasing Intrauterine System indicated for:

  • Intrauterine contraception for up to 5 years, in women who have at least one child.
  • Treatment of heavy menstrual bleeding for women who suffer from dysfunctional uterine bleeding and who are willing to accept LNG IUD as an alternative to hysterectomy or oral medications.

DOSAGE AND ADMINISTRATION

  • Release rate of Levonorgestrel is approximately 20 µg per day; Emily should be replaced after 5 years.
  • To be inserted by a trained healthcare provider using strict aseptic technique. Healthcare providers are advised to become thoroughly familiar with the insertion instructions before attempting insertion.
  • Patient should be re-examined and monitored 4 to 12 weeks after insertion; then, yearly or more often if indicated.

DOSAGE FORMS AND STRENGTHS

One sterile Intrauterine System consisting of M-shaped polyethylene frame with a steroid reservoir containing 52 mg Levonorgestrel held within an inserter tube.

WARNINGS AND PRECAUTIONS

  • If pregnancy occurs with Emily in place, remove Emily.
  • Increased risk of ectopic pregnancy
  • Group A streptococcal infection has been reported; strict aseptic technique is essential during insertion.
  • Before using Emily, consider the risks of PID.
  • Bleeding patterns become altered, may remain irregular and amenorrhea may ensue.
  • Perforation may occur during insertion. Risk is increased in women with fixed retroverted uteri, during lactation, and postpartum.
  • Embedment in the myometrium and partial or complete expulsion may occur.
  • Persistent enlarged ovarian follicles should be evaluated

ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials with a similar device (> 10%users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%) and ovarian cysts (12%).

DRUG INTERACTIONS

Drugs or herbal products that induce certain enzymes, such as CYP3A4 may decrease the serum concentration of progestins.

USE IN SPECIFIC POPULATIONS

  • Small amounts of progestins pass into breast milk resulting in detectable Steroid levels in infant serum.
  • Use of this product before menarche is not indicated.
  • Use in women over 65 has not been studied and is not approved.

FAQ

Frequently Asked Questions

What is Emily (Levenorgestrel Intra uterine system)?
How does Emily work?
It is not known exactly how Emily works. Emily may work in several ways. It may thicken your cervical mucus, thin the lining of your uterus, inhibit sperm movement and reduce sperm survival.
Emily may stop release of your egg from your ovary, but this is not the way it works in most cases. Most likely, these actions work together to prevent pregnancy. Emily can cause your menstrual bleeding to be less by thinning the lining of the uterus.
Is Emily effective in treating Abnormal Uterine Bleeding (AUB)?
Why should I prefer Emily?
  • Most easily insertable LNG-IUS available in the market for long term Contraception and effective treatment for Heavy Menstrual Bleeding.
  • Less systemic side effects like oral contraceptives.
  • Easy insertion with less pain.
  • Available at affordable cost.
  • Improve the health condition of anaemic women.
Is it a difficult process to insert Emily?
No, the insertion procedure usually takes a few minutes after your doctor has completed the pelvic examination. You will be protected from pregnancy as soon as insertion of the system is complete; however, it is best to wait 24 to 48 hours before having sexual intercourse. A reduction in menstrual blood loss should be apparent from the first menstrual cycle.
Will my periods change with Emily?
EMILY will affect your menstrual cycle. You might experience frequent spotting (a small amount of blood loss) or light bleeding in addition to your periods for the first 3 to 6 months. In some cases, you may have heavy or prolonged bleeding during this time. Overall, gradually, your menstrual period may disappear when using EMILY. Due to the hormone’s effect on the lining of the uterus it’s become thicken. Therefore there is little or no bleeding, as happens during a usual menstrual period. But, when the system is removed, periods should return to normal. Menstruation disappearance does not necessarily mean you have reached menopause or are pregnant. If, however, you are having regular menstrual periods and then do not have one for 6 weeks or longer, it is possible that you may be pregnant. You should consult with your doctor.
Which are the conditions were Emily should not be used?
EMILY is not suitable for every woman. Your doctor can advise you if you have any conditions that would pose a risk to you. You should not use EMILY if you:
  • have any allergies to the hormone levonorgestrel, or to any of the other ingredients of EMILY,
  • are pregnant, or if you suspect that you may be pregnant,
  • Currently have pelvic inflammatory disease (PID) or have a recurrent PID
  • had an infection of the uterus (womb)/cervix after delivering a baby or having abortion during the past 3 months
  • have a condition of the uterus that distorts the uterine cavity, such as large fibroids
  • have cell abnormalities in the cervix (your doctor can tell you if you have this)
  • have a known or suspected progestogen-dependent tumour, including breast cancer
  • have liver disease or liver tumor
  • have bacterial endocarditis (an infection of the heart valves or lining of the heart)
  • have immunodeficiency (a doctor will have told you if you have this)
  • have cancer affecting the blood, or if you have leukemia
  • have or have had trophoblastic disease (a doctor will have told you if you have this)
  • have cancer of the uterus or the cervix (uterine or cervical malignancy)
Are there any potential serious complications and any side effects with Emily?
Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death. Tell your healthcare provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

Embedment : Emily may become attached to the uterine wall. This is called embedment. If embedment happens, Emily may no longer prevent pregnancy and you may need surgery to have it removed.

Perforation : Emily may go through the uterus. This is called perforation. If your uterus is perforated, Emily may no longer prevent pregnancy. It may move outside the uterus and can cause internal Scarring, infection, or damage to other organs, and you may need surgery to have Emily removed.

Common Side Effects

  • Abdominal pain, Back pain, Breast pain,
  • Painful periods,
  • Altered mood, Headache,
  • Depression and Nervousness,
  • Genital discharge,
  • Vaginal hemorrhage,
  • Withdrawal bleeding,
  • Menorrhagia,
  • Vaginal infection,
  • Ovarian cyst
  • Decreased sex drive,
  • Weight increase,
  • Nausea,
  • Acne,
  • Skin disorder
How often should I see my doctor once Emily is placed?
You should have the system checked by your doctor approximately 4 to 12 weeks after it is fitted, again at 12 months and then once a year until it is removed. EMILY can stay in place for 3 years.
What should I do, if I wish to become pregnant?
If you wish to become pregnant, ask your doctor to remove EMILY. You can try to become pregnant as soon as Emily is removed.
Will my partner be able to feel Emily during intercourse?
During sexual intercourse, you or your partner should not be able to feel EMILY. If you can feel EMILY, or any pain or discomfort that you suspect may be caused by it, then you should not have sexual intercourse until you consult your doctor to verify it is still in the correct position.
Will Emily protect from HIV or STDs (sexually transmitted diseases)?
No. Emily (Levonorgestrel-releasing Intrauterine System) does not protect against HIV or STDs. So, if while using Emily you should think you or your partner is at a risk of getting an STD, use a condom and call your healthcare provider.

Clinical Studies

Emily has demonstrated significant clinical benefits in reducing heavy menstrual bleeding (HMB) within 6 months;
The prospective, multicentre, single-arm, phase 4 study involved 45 patients with significant heavy menstrual bleeding. The patients were treated with Emily over a period of 6 months and the patients had shown significant reduction in heavy menstrual bleeding at the end of 6 months. The results are as follows;
graph
Full Publication
Rajmohan Gopimohan , Amrutha Chandran , Joyce Jacob, Sunil Bhaskar , Rajeev Aravindhakshan , Abi S. Aprem. A clinical study assessing the efficacy of a new variant of the levonorgestrel intrauterine system for abnormal uterine bleeding. International Journal of Gynecology and Obstetrics 129 (2015) 114–117. -PDF Version

About R & D

R & D Centre, Thiruvananthapuram, Kerala

Through the interchange of creative, imaginative people, a global Research and Development (R & D) centre that encourages collaboration and cooperation among highly reputed research centres in the country; and a strong commitment to ongoing investment, we have put R & D at the centre of everything we do.
From Blood Transfusion Bags to Hydrocephalus Shunts, once-a-week Non Steroidal Oral Contraceptive Pills and several variants of condoms, every product from HLL is a result of innovation.
The last four decades have seen HLL network with various scientific and academic institutions of excellence for developing novel healthcare products. HLL has a state-of-the-art R & D centre at Thiruvananthapuram in Kerala, India.
R & D Centre, Thiruvananthapuram, Kerala
HLL's R & D centre has several projects in hand, carried out in-house or on collaborative mode, with premier academic and research institutions in the country and abroad. These projects cover a wide area of research ranging from development of novel techniques for drug delivery to blood filters, novel contraceptives and cancer-care devices. Some of the institutions HLL has networked with are-Indian Institute of Technology (IIT), Kanpur; Central Drug Research Institute (CDRI), Lucknow; Sree Chitra Thirunal Institute of Medical Sciences & Technology (SCTIMST), Thiruvananthapuram; Regional Cancer Centre (RCC), Thiruvananthapuram, and Population Council, USA.
HLL has set up a Technology Business Incubation centre (TBlC) at Rajiv Gandhi centre for Biotechnology (RGCB), Thiruvananthapuram. The goal of the TBlC is to develop novel, fast and easy-to-use diagnostic methodologies for various infectious diseases. As part of this collaboration, HLL has developed a duplex kit for viral infections. This project would be extended to development of newer and less expensive diagnostic kits.
Based on its technological competency, the R & D centre is implementing sponsored projects from organisations including Department of Science and Technology (DST), Defense Research Development Organisation (DRDO), Department of Biotechnology (DBT), Council of Scientific Industrial Research (CSlR) and international agencies like Bill & Melinda Gates Foundation.

Uterus defines your Womanhood

Save the Uterus

Save your Womanhood

The status of Indian women has been subjected to many great changes over the past few decades. From equal status with men in ancient times, to equal rights in modern era, history of Indian Women has been really eventful. Today, Women have held high offices in India including President, Prime Minister, to jobs like flying an Aircraft to Business Management and Teaching etc.

But the fate of Indian Women still remains the same when it comes to Healthcare Sector. Despite, several advancements in Healthcare Sector, due to societal cum medical reasons, women are left with no choice but to lose their Womanhood to the hands of Hysterectomy.

Medical reasons for Hysterectomy (Removal of Uterus) vary. Major reason for Hysterectomy is Heavy Menstrual Bleeding, referred in medical terms as Dysfunctional Uterine Bleeding. Almost 40-50% of women in the age group of 40-45 suffer from the problem of heavy bleeding, accompanied with pain and discomfort. This condition is called Heavy Menstrual Bleeding. While most of these cases can be treated by using Medical options, their ineffectiveness in some cases makes the doctors advise Hysterectomy.

In some parts of our country, post completion of the family, uterus is viewed as an unwanted organ. Women approach doctors for uterus removal. While this practice is unwarranted, uterus removal has many complications like increased risk of osteoporosis and heart diseases.

While more and more of Women, post family completion, are opting to remove the uterus to get rid of this indication, Doctors across the Globe have been advocating against the removal of uterus.As per recent data available, every year 40 Lac Indian women undergo Hysterectomy and lose their uterus. While a number of options are available to prevent Hysterectomy, Indian women have been deprived of the same. 

“Save the Uterus”, is an initiative by HLL Lifecare Limited (A Govt. of India Enterprise) to educate Indian women about complications involved post Hysterectomy and benefits of preserving their womanhood.

Here are few Frequently Asked Questions, by women who suffer from Heavy Menstrual Bleeding;

  1. What is Heavy Menstrual Bleeding? How will I know if I am suffering from it?
    • Heavy menstrual bleeding is defined as losing more than 80ml of blood over the course of a menstruation cycle.
    • You may be suffering from HMB if you are using more number of sanitary pads than normal, pass blood clots or are flooding with sudden heavy loss.
  2. What are the Treatment options available?
    • Treatment includes both medical and surgical options:
      • Medical options include Tranexamic acid, Oral Contraceptive Pills, Ormeloxifene and Hormonal Intra-Uterine Systems (Levonorgestrel based).
      • Surgical options include Hysterectomy and other endometrial procedures.
  3. I am already 45 and done with my family planning; shall I get my uterus removed as a permanent solution?
    • Many women feel that hysterectomy is a permanent solution while it may be a door to many other serious consequences.
    • Always refer your doctor for a second opinion and make sure that there is sufficient indication for hysterectomy.
  4. What are the consequences of Hysterectomy?
    • Injuries: to ureter or bladder bowel
    • Hemorrhage: one of the most serious post-operative complication
    • Infection: 4% to 25% patients suffer from it after hysterectomy
    • Urinary incontinence, high risk of osteoporosis & heart diseases
    • Pain, hot flashes, vaginal dryness, weight gain,  depression, decreased libido
  5. My doctor has prescribed me some medicine, but still I am suffering from Heavy Menstrual Bleeding. Should I undergo Hysterectomy?
    • Medicines are prescribed by doctor as a first line of treatment in Management of Heavy Menstrual Bleeding. However, if these medications fail to provide you relief, Hormonal Intra-Uterine Systems (like EMILY) are suggested to treat to Indication.
    • IUS are one of the most effective and economical alternative to hysterectomy in most cases of Heavy Menstrual Bleeding.
    • With marked reduction in Blood loss, they improve the quality of life by reducing the pain associated with bleeding.
    • Studies suggest that 70% of hysterectomies cases can be prevented using Hormonal-Intra Uterine Systems
  6. I want to “Save my Uterus”. How will I get a Hormonal Intra-Uterine System?
    • Hormonal Intra-Uterine systems are devices which are inserted in body by a doctor only.
    • For insertion of an IUS, please refer to your doctor for Hormonal IUS (EMILY)
    • For more information on Hormonal Intra-Uterine Systems, please visit www.emily.org.in

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