Mirena IUD (Levonorgestrel intrauterine device) is a progestin-only-containing hormonal contraceptive device. It does not contain estrogen. It is used to prevent pregnancy for 3 to 6 years depending on the brand and dose of the intrauterine device.

Levonorgestrel Intrauterine Device Uses:

• Contraception:

  • A hormonal drug called levonorgestrel is used to prevent pregnancy (up to 3 years [Skyla], up to 5 years [Kyleena, Mirena], or up to 6 years [Liletta]).

• Heavy menstrual bleeding (Mirena only):

  • When a woman opts for an IUD as a method of contraception, it is also utilized to alleviate heavy menstrual bleeding.

• Off-Label Use of Levonorgestrel intrauterine device in Adults:

  • Additionally, it is applied to the management of endometrial hyperplasia. It is solely applied to females and inserted into the uterus cavity as an intrauterine device (IUD).

Levonorgestrel Intrauterine Dose in Adults:

Levonorgestrel Intrauterine Device Dose in the Treatment of Contraception:

• Kyleena:
  • It first releases levonorgestrel at a rate of up to 17.5 mcg/day approximately; after that, the rate gradually declines over time, averaging 9 mcg/day over five years.
  • It should not be placed for more than 5 years.
• Liletta:
  • Levonorgestrel is first released at a rate of up to 20 mcg daily, roughly, and then the rate steadily decreases over time, averaging 14.3 mcg during six years.
  • It should not be placed for more than 6 years.
• Mirena:
  • The initial release rate is 20 mcg/day, and after five years, the rate drops to half or 10 mcg/day.
  • It should not be placed for more than 5 years.
• Skyla, Jaydess (Canadian product):
  • After 24 days, the initial release rate is roughly 14 mcg/day. Thereafter, the rate gradually declines, reaching a mean release rate of roughly 6 mcg/day after 3 years.
  • It should not be in place for more than 3 years.
• Initiation of therapy:
  • If pregnancy has been ruled out, it can be implanted on any day of the menstrual cycle, just after delivery, or right after a first or second-trimester abortion (whether spontaneous or induced).
  • Within 7 days following the start of menstruation, backup contraception is not necessary. However, if insertion happens more than 7 days after the start of monthly bleeding, supplementary contraception must be taken for 7 days, unless the woman abstains from sexual activity.
  • If an intrauterine device is implanted at the time of surgical abortion, further contraception is not required.
  • Insertion should be delayed following a septic abortion.
• Note:
  • Although the aforementioned recommendations do support IUD insertion immediately postpartum or after a second-trimester abortion or miscarriage (refer to the manufacturer's labeling for product-specific information), the manufacturer's labeling advises against doing so until at least 4 weeks have passed or the uterus has fully evolved.
  • Healthcare providers should determine the appropriate timing of device insertion.
• Continuation of contraception:
  • As long as the woman is not pregnant, an intrauterine device can be removed immediately and replaced with a new one at any point during the menstrual cycle.

Additional contraceptive dosing considerations:

• Switching from a different contraceptive to levonorgestrel IUD:
  • If the lady is not pregnant, the IUD can be put in right away.
    Within 7 days following the start of menstruation, backup contraception is not necessary. However, if
  • insertion happens more than 7 days after the start of monthly bleeding, supplementary contraception must be taken for 7 days unless the woman abstains from sexual activity.
  • Continue the woman's prior method for 7 days following insertion if the second method of contraception is required.
• Switching from a copper IUD:
  • If the sexual activity has taken place after the beginning of the current cycle and bleeding has persisted for more than five days, emergency contraception must be used.
• Switching to Kyleena, Liletta, Mirena, or Skyla from an injectable progestin contraceptive:
  • During any phase of the menstrual cycle, may be inserted.
  • If a barrier method of contraception is implanted after 13 weeks have passed since the last injection, it must be utilized for 7 days.
• Switching to Kyleena, Liletta, Mirena, or Skyla from a contraceptive implant or another intrauterine system:
  • The implant or device may be inserted at any time during the menstrual cycle, but it must be withdrawn the following day.
• Switching to Kyleena, Liletta, Mirena, or Skyla from a hormonal contraceptive (oral, transdermal, vaginal):
  • Any time during the menstrual cycle, including the previous method's hormone-free phase, may be inserted.
  • The preceding procedure should be continued for seven days following insertion or, if done while the previous approach is being used actively, until the end of the current treatment cycle.
• Switching from levonorgestrel IUD to a different contraceptive:
  • Start the new method of birth control and remove the levonorgestrel IUD within the first seven days of the menstrual cycle if the patient wants to transition from it to another technique.
  • A backup barrier contraceptive method should be used for 7 days after the device is removed unless the woman abstains from vaginal contact if the device is not removed during the first 7 days of menstruation, the patient has irregular menstrual cycles, or the patient has amenorrhea and wants to switch to a different method of birth control.

Mirena IUD (Levonorgestrel intrauterine device) Dose in the treatment of Endometrial hyperplasia (off-label):

• Intrauterine device (Mirena):
  • The dosage for endometrial hyperplasia is 20 mcg per day.
  • The ideal length of therapy is unknown, however, Mirena includes 52 mg of levonorgestrel in a reservoir that releases 20 mcg per day over five years and should be left in place for longer than five years.

Mirena IUD (Levonorgestrel intrauterine device) Dose in the treatment of heavy menstrual bleeding:

• • Refer to the dosing for contraception given above while using an intrauterine device (Mirena).

Levonorgestrel Intrauterine Dose in Children:

Mirena IUD (Levonorgestrel intrauterine device) Use for Contraception in adolescents:

• Not recommended in prepubertal children and sexually inactive girls.

Mirena IUD (Levonorgestrel intrauterine device) Pregnancy Risk Category: X

• It is not advised to use it if you are pregnant or fear you might be pregnant.
  IUD users who become pregnant while using one are at risk for septic abortion. Septicemia, septic shock, and even death could result from this.
• Before a pregnancy is inserted, always rule out the possibility of it.
• When IUD is in place and pregnancy occurs, the probability of ectopic birth is higher. If pregnancy is continued, there is an increased chance of miscarriage and sepsis.
• After a first trimester spontaneous or induced abortion, you can put the device in right away.
• The device's manufacturer advises against using it before the uterus has fully evolved after a pregnancy or an abortion inflicted during the first trimester, which could take up to 6 weeks.
• However, the aforementioned suggestions encourage the placement of an IUD directly after childbirth, as well as right away following a miscarriage or second-trimester abortion.
• Evidence-based guidelines advise postpartum insertion (i.e., immediate or interval insertion within 6 weeks of placental birth) and postabortion insertion.
• This is true even if there is an increased risk of ejection right after an abortion.
• It may also be offered to women who are breastfeeding, regardless of their breastfeeding status, to prevent unintended pregnancies and rapid repeats.
• Around 71% to 88% percent of women who want to conceive can do so within 12 months of the device's removal.

Levonorgestrel intrauterine device use during breastfeeding:

• Breast milk contains levonorgestrel.
• After IUD insertion, breast milk was found to contain levonorgestrel in women who had given birth between 4 and 6 weeks ago.
• One study found no correlation between maternal serum and milk concentrations. However, the authors determined that infants were given a relative dose of 1.2%.
• Both studies showed that the milk/plasma ratio increased in both the 12- and 4-week periods.
• Levonorgestrel could also be detected in breastfeeding infant serum.
• Actual milk concentrations will vary depending on how much and whereabouts they were administered.
• Additionally, maternal plasma levels of levonorgestrel depend on SHBG capacity. This is affected by estrogen concomitantly administered or the mother's postpartum status.
• There have been no adverse effects observed on the development or growth of infants in general.
• There have been isolated cases of reduced milk production.
• Lactating women are at greater risk of IUD perforation.
• According to the manufacturer of the product, when deciding whether to continue or stop breastfeeding during therapy, it should consider the risks to infant exposure, the benefits to the infant, and the benefits to the mother.
• The manufacturer suggests that the device not be inserted during pregnancy until six weeks after delivery or until the involution has occurred.
• The guidelines state that levonorgestrel IV may be used immediately after birth in breastfeeding women. This includes women who have had a cesarean section.
• Although the risk of infection is not higher, expulsion risks may be greater.
• This should be considered in conjunction with the need to provide effective contraception and patient access for placement.

Dose in Kidney Disease:

There are no dosage adjustments provided in the manufacturer's labeling (it has not been studied).

Dose in Liver disease:

The intrauterine device should not be used if there is active liver disease or a hepatic tumor, according to the manufacturer's labeling (which has not been investigated).

Common Side Effects of Mirena IUD (Levonorgestrel intrauterine device):

• Central Nervous System:

  • Headache
  • Migraine

• Dermatologic:

  • Acne Vulgaris
  • Seborrhea

• Endocrine & Metabolic:

  • Heavy Menstrual Bleeding
  • Amenorrhea
  • Intermenstrual Bleeding
  • Ovarian Cyst

• Gastrointestinal:

  • Abdominal Pain

• Genitourinary:

  • Abnormal Uterine Bleeding
  • Irregular Menses
  • Vulvovaginitis
  • Pelvic Pain
  • Vaginal Infection
  • Vulvovaginal Infection
  • Vaginal Discharge

Less Common Side Effects Of Mirena IUD (Levonorgestrel intrauterine device):

• Central Nervous System:

  • Anxiety
  • Depression
  • Mood Changes

• Dermatologic:

  • Pruritus
  • Skin Rash
  • Urticaria
  • Alopecia

• Endocrine & Metabolic:

  • Infrequent Uterine Bleeding
  • Weight Gain
  • Decreased Libido
  • Hirsutism

• Gastrointestinal:

  • Abdominal Distress
  • Nausea
  • Vomiting

• Genitourinary:

  • Breast Tenderness
  • Dysmenorrhea
  • Uterine Spasm
  • Mastalgia
  • Dyspareunia
  • Endometritis
  • Genitourinary Infection

• Neuromuscular & Skeletal:

  • Back Pain

Side effects of Mirena IUD (Levonorgestrel intrauterine device) Frequency Not Defined:

• Central Nervous System:

  • Bipolar Mood Disorder
  • Exacerbation Of Depression
  • Suicidal Tendencies

Contraindications to Mirena IUD (Levonorgestrel intrauterine device):

• Hypersensitivity to levonorgestrel 
• Pregnancy or suspected pregnancy
• postcoital contraception;
• Obstacles to the appropriate implantation of an IUD include congenital or acquired uterine abnormalities, such as fibroids, which deform uterine cavities.
  illness or history of acute pelvic inflammation (except if there was a subsequent intrauterine birth)
• Infected abortions or postpartum endometritis within the past three months
• There is a possibility of uterine or cervical cancer.
• Acute bacterial vaginitis, also known as chlamydial cervical infection or gonococcal infection, as well as other lower genital tract infections, should be treated if they are left untreated until the infection is under control.
• Conditions that increase the susceptibility to pelvic infection;
• Unremoved IUD
• Unknown uterine bleeding;
• Acute hepatic disease (benign and malignant) or hepatic tumors
• Current or past history of breast cancer, or any other hormone-sensitive type of cancer,

Canadian labeling: Additional contraindications not in US labeling

• Bacterial endocarditis;
• Recent trophoblastic diseases are accompanied by elevated levels of human chorionic Gonadotropin (hCG), hormones
• Cervical dysplasia
• known immunodeficiency (Mirena), or hematologic malignancy

Warnings and precautions

• Bleeding irregularities:

  • The intrauterine device (IUD), which can alter menstrual bleeding patterns, may cause spotting, irregular bleeding, and amenorrhea.
  • It is possible to get pregnant if the menstrual cycle does not begin within six weeks.
  • If you experience persistent bleeding, it is worth performing diagnostic tests to rule out cancerous endometrial disease (polyps)
  • An increase in monthly flow might be a sign that the IUD has been partially or entirely removed (see dosage forms specific issues).
  • It is important to evaluate unexplained vaginal bleeding before insertion.

• Bradycardia/syncope

  • Patients with predisposing conditions to syncope or Bradycardia may experience syncope or syncope during the insertion or removal.

• Breast cancer

  • Breast cancer is a hormone-sensitive tumor.
  • Women with a breast cancer history or who have had it are advised to not use this product.
  • Levonorgestrel-releasing IUDs have been linked to breast cancer reports.

• Ectopic pregnancy

  • Patients with a history of ectopic pregnancy should be cautious.
  • Clinical trials were not conducted for women who have had ectopic pregnancies in the past.
  • Ectopic pregnancies may be more likely to occur in women who have had tubal ligation surgery, pelvic infections, or both.
  • Patients with lower abdominal pain should be aware that ectopic pregnancy is possible, particularly if they have missed periods or are experiencing new-onset vaginal bleeding.
  • An ectopic pregnancy can lead to a loss in fertility.

• Ocular effects

  • If you experience ophthalmic discomfort or problems, such as contact lens issues or ocular pain, your IUD might need to be removed temporarily or permanently.

• Ovarian cysts

  • It might happen when wearing an IUD. The majority of cases are asymptomatic and go away on their own in 2 to 3 months.
  • If you are persistent, it is time to evaluate.

• Pelvic inflammatory Disease:

  • Use of actinomycosis has been associated with an increase in group A streptococcal and pelvic inflammatory diseases (PID), or endometritis.
  • To minimize the chance of serious infections, it is important to use an aseptic technique for insertion.
  • PID occurs most frequently within the first month after implantation and is more likely in the first year than in the second.
  • With more partners, the possibility of PID grows.
  • The risk is higher for women who have a history of endometritis or PID.
  • PID should be treated according to the current guidelines. Reassess within 48 to 72 hours.
  • Continue antibiotics if there is no improvement in clinical symptoms. If the situation continues, consider removing the device.
  • The device should be removed from women suffering from symptomatic actinomycosis and treated with the appropriate antibiotics.
  • Recurrent endometritis, PID, or severe acute pelvic infections that do not respond to treatment may require the removal of an IUD.

• Seizure:

  • Seizures can be caused by insertion or removal, particularly in those who are predisposed to them.

• Endometrial or cervical cancer:

  • An IUD should not be used for pregnancy prevention if a woman has been diagnosed with endometrial or cervical cancer.
  • The IUD can be removed by women who have been diagnosed with a pregnancy after the insertion.
  • Women with progestin-sensitive breast cancer should not use this medication.

• Depression

  • Patients with depression should exercise caution because they may be more susceptible to depressive episodes returning.
  • In the event of a significant recurrence, think about having the IUD removed.
  • The IUD can be used by anyone, regardless of their mood.

• Gestational trophoblastic Disease:

  • When pregnancy occurs, women with gestational trophoblastic disorders are more vulnerable to negative outcomes.
  • Levonorgestrel IVUD use as a method of birth control may be an option in some circumstances.
  • Levonorgestrel IVD therapy should not be administered to women who have intrauterine illnesses and/or high beta-hCG levels or a malignant condition.
  • There are risks of infection, hemorrhage, or perforation.
  • For women who have a levonorgestrel-IUD, you should balance the benefits of efficient contraception against the risks of keeping or getting rid of it.

• Sepsis:

  • Women with postpartum sepsis and women who have had septic abortions should not use the levonorgestrel-IUD.

• Sexually transmitted disease

  • Women with chlamydial, purulent cervicitis, or gonococcal infections should not use the levonorgestrel-IUD.
  • If the IUD is in place and a diagnosis is made, it does not have to be removed.
  • As long as appropriate antibiotics are used and personal risk factors are considered and patients' preferences are taken into account.

• Tuberculosis

  • Women with non-pelvic tuberculosis may have the levonorgestrel IUD inserted. If pelvic infections occur, do not start treatment.

Levonorgestrel intrauterine device: Drug Interaction

Monitoring parameters:

Prior to insertion:

• Assessment of pregnancy status
• bimanual examination and cervical inspection
• weight
• BMI 
• STD screen
• Complete medical and social history that may help identify factors affecting the usage of an IUD for contraception.

Following Mirena insertion:

• To verify the location, a transvaginal ultrasound machine may be employed.
• At routine follow-up visits, changes in health status (including medication use) should be evaluated.
• Reexamine 4 to 6 weeks after insertion for Kyleena, Liletta, Mirena, and Skyla; 4 to 12 weeks for Jaydess (a Canadian product); and thereafter annually or as frequently as needed.
• The device may have become dislodged, fractured, punctured the uterus, or been expelled if the length of the thread has changed. Threads should be visible.
• When using for an extended period of time, keep an eye on your Pap smear, blood pressure, and serum glucose levels in diabetic people.
• Patients who report lower abdomen pain should have ovarian cysts and ectopic pregnancies checked out.
  indicators of infection
• When women need surgery that involves lengthy immobility, keep an eye out for any indications or symptoms of thromboembolism.

Endometrial hyperplasia, treatment (off-label use):

• Endometrial samples should be taken every three to six months, while the best frequency has not yet been identified.

How to administer Mirena IUD (Levonorgestrel intrauterine device)?

Intrauterine device:

• Before inserting, think about giving painkillers or cervical anesthesia.
• Use the accompanying insertion device to place the device into the uterine cavity to the prescribed depth; the uterus should not be pressed.
• Consider employing a paracervical block and dilating the cervical canal if necessary.
• The correct positioning may be checked via transvaginal ultrasound.
• If the IUD is not positioned correctly, remove it and place a new one; do not put the old one back in.
• If severe pain or bleeding happens right after insertion, rule out uterine perforation.
• After removal, make sure the gadget is still intact.

Mechanism of action of Mirena IUD (Levonorgestrel intrauterine device):

• Levonorgestrel can prevent pregnancy by several mechanisms
• Thickening cervical mucus can cause sperm death and blockage of sperm passage through the body.
• A negative feedback system at the hypothalamus is what prevents ovulation.
• This results in reduced secretion and activity of luteinizing hormones (LH) as well as follicle-stimulating hormonal (FSH).
• Modifying the endometrium can affect implantation.
• Once the implantation process is complete, Levonorgestrel will no longer be effective.

Duration:

• Liletta: Up to 6 years;
• Kyleena, Mirena: Up to 5 years;
• Skyla, Jaydess [Canadian product]: Up to 3 years.

Protein binding:

• Highly bound to albumin (~50%) and sex hormone-binding globulin (~47%).

Metabolism:

• Hepatic via CYP3A4; forms inactive metabolites.

Excretion:

• Urine (~45%); feces (~32%).

International Brand Names of Levonorgestrel intrauterine device:

• Kyleena
• Liletta (52 MG)
• Mirena (52 MG)
• Skyla
• Jaydess
• Contraplan II
• Fleree
• Janess
• Levosert
• Lovosert
• Mirena

Levonorgestrel IUD Brand Names in Pakistan:

Brands in Pakistan will be updated later.

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