levonorgestrel intrauterine (Rx)

Brand and Other Names:Mirena, Skyla, more...Liletta, Kyleena
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

levonorgestrel-releasing intrauterine system

  • 13.5mg/device (Skyla)
  • 19.5mg/device (Kyleena)
  • 52mg/device (Liletta, Mirena)

Contraception

Mirena

  • Initial levonorgestrel release rate is 20 mcg/day; rate reduced by 50% after 5 years
  • May remove and replace with a new unit anytime during menstrual cycle
  • Must be removed or replaced by 5 years following insertion

Skyla

  • Levonorgestrel release rate is 14 mcg/day after 24 days and 5 mcg/day after 3 years
  • May remove and replace with a new unit anytime during menstrual cycle
  • Must be removed or replaced by 3 years following insertion

Liletta

  • Initially, levonorgestrel release rate is ~20 mcg/day; rate decreases progressively to ~8.6 mcg/day after 6 yr
  • Average in vivo release rate is ~14.3 mcg/day over a period of 6 yr
  • May remove and replace with a new unit anytime during menstrual cycle
  • Must be removed or replaced by the end of sixth year following insertion

Kyleena

  • Release rate is 17.5 mcg/day after 24 days and declines to 7.4 mcg/day after 5 years
  • May remove and replace with a new unit anytime during menstrual cycle
  • Must be removed or replaced by 5 years following insertion

Dosage Modifications

Renal or hepatic impairment: No studies conducted

Dosing Considerations

Starting levonorgestrel intrauterine in women not currently using hormonal or intrauterine contraception

  • Insert any time the healthcare professional assesses the woman is not pregnant
  • Consider the possibility of ovulation and conception before initiation of this product
  • If inserted during the first 7 days of the menstrual cycle or immediately after a first trimester abortion, back up contraception is not needed
  • If NOT inserted during the first 7 days of the menstrual cycle, use a barrier method of contraception or abstain from vaginal intercourse for 7 days to prevent pregnancy

Switching to intrauterine from an oral, transdermal, or vaginal hormonal contraceptive

  • Insert intrauterine device at any time
  • May be inserted during the hormone-free interval of the previous method
  • If inserted during active use of the previous method, continue that method for 7 days after intrauterine device insertion or until current treatment cycle has ended
  • If using continuous hormonal contraception, discontinue that method 7 days after insertion

Switching to levonorgestrel intrauterine from an injectable progestin contraceptive

  • May be inserted at any time
  • If inserted >3 months (13 weeks) after the last injection, use a barrier method of contraception (eg, condoms, spermicide) for 7 days after insertion

Switching to intrauterine from a contraceptive implant or another IUS

  • Insert intrauterine on the same day the implant or IUS is removed; may be insert at any time during the menstrual cycle.

Inserting intrauterine after abortion or miscarriage

  • First-trimester: May insert immediately after a first-trimester abortion or miscarriage.
  • Second-trimester: Delay inserting intrauterine until a minimum of 4 weeks (Liletta) or 6 weeks (Kyleena, Skyla, Mirena) after second-trimester abortion or miscarriage, or until the uterus is fully involuted
  • If involution is delayed, wait until involution is complete before insertion
  • If the woman has not yet had a period, consider the possibility of ovulation and conception occurring before insertion
  • Insert at any time the healthcare professional assesses woman is not pregnant
  • If not inserted during the first 7 days of the menstrual cycle, use a barrier method of contraception or abstain the patient from vaginal intercourse for 7 days after insertion to prevent pregnancy

Inserting after childbirth

  • Delay insertion until a minimum of 4 weeks (Liletta) or 6 weeks (Kyleena, Skyla, Mirena) after delivery, or until the uterus is fully involuted
  • If involution is delayed, wait until involution is complete before insertion
  • If woman has not yet had a period, consider the possibility of ovulation and conception occurring before insertion
  • May be inserted any time the healthcare professional assesses the woman is not pregnant
  • If not inserted during the first 7 days of the menstrual cycle, use a barrier method of contraception or abstain from vaginal intercourse for 7 days after insertion to prevent pregnancy
  • Increased risk of perforation in lactating women

Dosage Forms & Strengths

levonorgestrel-releasing intrauterine system

  • 13.5mg/device (Skyla)
  • 19.5mg/device (Kyleena)
  • 52mg/device (Liletta, Mirena)

Contraception

Postpubertal females

  • Skyla
    • Levonorgestrel release rate is 14 mcg/day after 24 days and 5 mcg/day after 3 years
    • May remove and replace with a new unit anytime during menstrual cycle
    • Must be removed or replaced by 3 years following insertion
  • Liletta
    • Initially, levonorgestrel release rate is ~20 mcg/day; rate decreases progressively to ~8.6 mcg/day after 6 yr
    • Average in vivo release rate is ~14.3 mcg/day over a period of 6 yr
    • May remove and replace with a new unit anytime during menstrual cycle
    • Must be removed or replaced by the end of sixth year following insertion
  • Mirena
    • Initial levonorgestrel release rate is 20 mcg/day; rate reduced by 50% after 5 years
    • May remove and replace with a new unit anytime during menstrual cycle
    • Must be removed or replaced by 5 years following insertion
  • Kyleena
    • Release rate is 17.5 mcg/day after 24 days and declines to 7.4 mcg/day after 5 years
    • May remove and replace with a new unit anytime during menstrual cycle
    • Must be removed or replaced by 5 years following insertion

Dosage Modifications

Renal or hepatic impairment: No studies conducted

Dosing Considerations

Starting levonorgestrel intrauterine in women not currently using hormonal or intrauterine contraception

  • Insert any time the healthcare professional assesses the woman is not pregnant
  • Consider the possibility of ovulation and conception before initiation of this product
  • If inserted during the first 7 days of the menstrual cycle or immediately after a first trimester abortion, back up contraception is not needed
  • If NOT inserted during the first 7 days of the menstrual cycle, use a barrier method of contraception or abstain from vaginal intercourse for 7 days to prevent pregnancy

Switching to intrauterine from an oral, transdermal, or vaginal hormonal contraceptive

  • Insert intrauterine device at any time
  • May be inserted during the hormone-free interval of the previous method
  • If inserted during active use of the previous method, continue that method for 7 days after intrauterine device insertion or until current treatment cycle has ended
  • If using continuous hormonal contraception, discontinue that method 7 days after insertion

Switching to levonorgestrel intrauterine from an injectable progestin contraceptive

  • May be inserted at any time
  • If inserted >3 months (13 weeks) after the last injection, use a barrier method of contraception (eg, condoms, spermicide) for 7 days after insertion

Switching to intrauterine from a contraceptive implant or another IUS

  • Insert intrauterine on the same day the implant or IUS is removed; may be insert at any time during the menstrual cycle.

Inserting intrauterine after abortion or miscarriage

  • First-trimester: May insert immediately after a first-trimester abortion or miscarriage.
  • Second-trimester: Delay inserting intrauterine until a minimum of 4 weeks (Liletta) or 6 weeks (Kyleena, Skyla, Mirena) after second-trimester abortion or miscarriage, or until the uterus is fully involuted
  • If involution is delayed, wait until involution is complete before insertion
  • If the woman has not yet had a period, consider the possibility of ovulation and conception occurring before insertion
  • Insert at any time the healthcare professional assesses woman is not pregnant
  • If not inserted during the first 7 days of the menstrual cycle, use a barrier method of contraception or abstain the patient from vaginal intercourse for 7 days after insertion to prevent pregnancy

Inserting after childbirth

  • Delay insertion until a minimum of 4 weeks (Liletta) or 6 weeks (Kyleena, Skyla, Mirena) after delivery, or until the uterus is fully involuted
  • If involution is delayed, wait until involution is complete before insertion
  • If woman has not yet had a period, consider the possibility of ovulation and conception occurring before insertion
  • May be inserted any time the healthcare professional assesses the woman is not pregnant
  • If not inserted during the first 7 days of the menstrual cycle, use a barrier method of contraception or abstain from vaginal intercourse for 7 days after insertion to prevent pregnancy
  • Increased risk of perforation in lactating women
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Interactions

Interaction Checker

and levonorgestrel intrauterine

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Unscheduled uterine bleeding (31.9%)

            Decreased uterine bleeding (23.4%)

            Abdominal/pelvic pain (22.6%)

            Amenorrhea (18.4%)

            Headache/migraine (16.3%)

            Genital discharge (14.9%)

            Increased scheduled uterine bleeding (11.9%)

            Vulvovaginitis (10.5%)

            1-10%

            Breast pain (8.5%)

            Back pain (7.9%)

            Benign ovarian cyst and associated complications (7.5%)

            Acne (6.8%)

            Dysmenorrhea (6.4%)

            Depression/depressive mood (6.4%)

            Female genital tract bleeding (3.5%)

            <1%

            Angioedema

            Cervical perforation

            Failed insertion

            Sepsis

            Uterine bleeding

            Device breakage

            Pulmonary emboli

            Deep vein thrombosis and stroke

            Increased blood pressure

            Postmarketing Reports

            Arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli, deep vein thrombosis and stroke

            Device breakage

            Hypersensitivity (eg, rash, urticaria and angioedema)

            Increased blood pressure

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            Warnings

            Contraindications

            Pregnancy or suspicion of pregnancy; cannot be used for postcoital contraception

            Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity

            Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy

            Postpartum endometritis or infected abortion in the past 3 months

            Known or suspected uterine or cervical neoplasia

            Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past

            Uterine bleeding of unknown etiology

            Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled

            Acute liver disease or liver tumor (benign or malignant)

            Conditions associated with increased susceptibility to pelvic infections

            Previously inserted intrauterine device (IUD) that has not been removed

            Hypersensitivity to any component of this product

            Cautions

            Pregnant women whose device cannot be removed or if patient chooses not to have it removed, increases risk of miscarriage, sepsis, premature labor and premature delivery

            Evaluate women for ectopic pregnancy; ~50% of pregnancies that occur with IUD are likely to be ectopic

            Severe infection, including group A streptococcal sepsis reported

            Bleeding pattern alterations may occur, including amenorrhea, infrequent bleeding, prolonged bleeding, or irregular bleeding

            Increases risk for pelvic inflammatory disease

            Perforation may occur, most often during insertion; an interim analysis from a large postmarketing safety study shows an increased risk of perforation in lactating women; perforation risk may be increased in women with fixed retroverted uteri, and during the postpartum period; perforation may also occur at any time during IUS use; perforation may reduce contraceptive efficacy and result in pregnancy; this may be associated with severe pain and continued bleeding

            Expulsion may occur resulting in loss of contraceptive protection; if expulsion occurs, a new device can be inserted any time the provider can be reasonably certain the woman is not pregnant; expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed; consider further diagnostic imaging, such as sonography or X-ray, to confirm expulsion if device is not found in the uterus; the risk of expulsion may be increased when uterus is not completely involuted at time of insertion; delay insertion a minimum of 4 weeks or until uterine involution is complete following a delivery or a second trimester abortion

            Inform women who use product about recognizing signs and symptoms of ectopic pregnancy and promptly reporting them to their healthcare professional, and about the associated risks of ectopic pregnancy (eg, loss of fertility)

            Exclude underlying endometrial pathology (eg, polyps or cancer) prior to insertion of device in women with persistent or uncharacteristic bleeding; irregular bleeding/spotting is common during first months of use and may preclude adequate assessment after insertion

            Assess whether woman is at increased risk of infection (eg, leukemia, acquired immune deficiency syndrome [AIDS], IV drug abuse), or has history of PID unless there has been a subsequent intrauterine pregnancy; device does not protect against HIV/STI transmission

            If the threads are not visible or are significantly shortened, they may have broken or retracted into cervical canal or uterus; consider possibility that IUS may have been displaced, (for example, expulsed or perforated the uterus); exclude pregnancy and verify location of device by an appropriate diagnostic method

            Product not intended for use in menopausal women

            Women with symptomatic actinomycosis should have device removed and should receive antibiotics

            Ovarian cysts may occur

            MRI

            • Safe scanning with MRI may occur under specific conditions
            • static magnetic field ≤3 Tesla
            • spatial gradient field ≤36,000 Gauss/cm (T/m)
            • maximum SAR (whole body) of 4W/kg in first level controlled mode for 15 min

            Clinical Considerations for Use and Removal

            • Coagulopathy or use of anticoagulants
            • Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
            • Exceptionally severe headache
            • Marked increase of blood pressure
            • Severe arterial disease such as stroke or myocardial infarction
            • Consider removing device if jaundice or uterine or cervical malignancy occur during use
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            Pregnancy & Lactation

            Pregnancy

            Contraindicated in pregnancy or with a suspected pregnancy; there is no need for pregnancy prevention in a woman who is already pregnant and the therapy may cause adverse pregnancy outcomes; if a woman becomes pregnant, the likelihood of ectopic pregnancy is increased and there is increased risk of miscarriage, sepsis, premature labor, and premature delivery; remove the device, if possible, if pregnancy occurs and the device cannot be removed, follow the pregnancy closely

            Studies report no adverse effects on fetal and infant development associated with long-term use of contraceptive doses of oral progestins in a pregnant woman; however, cases of masculinization of the external genitalia of the female fetus reported following exposure to progestins at doses greater than those currently used for oral contraception

            Lactation

            Published studies report presence of LNG in human milk; small amounts of progestins (approximately 0.1% of the total maternal doses) were detected in breast milk of nursing mothers who used the device, resulting in exposure of LNG to breastfed infants; there are no reports of adverse effects in breastfed infants with maternal use of progestin-only contraceptives; isolated cases of decreased milk production reported; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for the device and any potential adverse effects on breastfed child from the drug or from the underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic progestin, inhibits ovulation by negative feedback mechanism on hypothalamus, leading to reduced secretion of FSH and LH

            Pharmacokinetics

            Duration of action: 5 years

            Protein Bound: 50%

            Vd: Implant (subdermal): 260 L/kg

            Metabolism: Liver

            Metabolites: tetrahydrolevonorgestrels, hydroxynorgestre, conjugates of sulfate or glucuronide

            Half-Life: 11-45 hr

            Excretion: Mainly in urine

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            Administration

            Topical Administration

            Ensure use of aseptic technique throughout the entire procedure

            Open package; do NOT move the slider downward at this time as this may prematurely release the threads of the device

            Once the slider is moved below the mark, device cannot be reloaded

            Set the flange

            Device is ready to be inserted ~1.5–2 cm from the cervix

            Do not force inserter; if necessary, dilate cervical canal

            Advance to fundal position; release insertion

            Storage

            Store at 25ºC (77ºF); excursions permitted to 15–30ºC (59–86ºF)

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
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