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)
  • 20mcg/24hr (Mirena)
  • 52mg/device (Liletta)

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 progressively decreases to about 50% after 5 yr
  • May remove and replace with a new unit anytime during menstrual cycle
  • Must be removed or replaced by the end of fifth 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

Menorrhagia

Indicated for heavy menstrual bleeding for women who choose to use intrauterine contraception (Mirena only)

Insert into uterine cavity within 7 days of mensturation onset or immediately after first trimester abortion

Mirena: Initial levonorgestrel release rate is 20 mcg/day; rate reduced by 50% after 5 years; must be removed or replaced after 5 years

Dosing Considerations

Insert within 7 days of onset of menses or immediately after first trimester abortion

Re-examine and evaluate patient 4-6 weeks after insertion; then yearly or more often if indicated

Switching to Different Contraceptive

Regular menstrual cycle: Remove device during first 7 days of menstrual cycle and begin new therapy

Irregular menstrual cycle: Start new contraceptive method 7 days prior to device removal

Safety and efficacy not established

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Interactions

Interaction Checker

and levonorgestrel intrauterine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (12%)

            Acne (15%)

            Ovarian cysts (13%)

            Enlarged follicles (12%)

            Amenorrhea (1-12%)

            Abdominal pain (12%)

            Uterine/vaginal bleeding alterations (52%)

            Intermenstrual bleeding/spotting (23%)

            Vulvovaginitis (20%)

            Ectopic pregnancy (≤50%)

            1-10%

            Depression (4%)

            Migraine (2%)

            Alopecia (1%)

            Dysmenorrhea (9%)

            Menorrhagia (6%)

            Breast tenderness (3-9%)

            Pelvic pain (6%)

            Leukorrhea (5%)

            Vaginal discharge (4%)

            Pelvic infection (1%)

            <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

            Acne

            Bacterial vaginitis

            Vulvovaginal mycotic infection

            Dyspareunia

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            Warnings

            Contraindications

            Documented hypersensitivity; genital actinomycosis, cervicitis or vaginitis, conditions associated with increased susceptibility to infections (eg, leukemia, AIDS, IV drug abuse), history of ectopic pregnancy, postpartum endometriosis, unremoved IUD, pelvic inflammatory disease, uterine anomaly, including fibroids, that distort the uterine cavity

            Active or suspected carcinoma of the breast or history of breast cancer

            Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

            Liver disease, liver tumors

            Undiagnosed abnormal vaginal bleeding

            Uncontrolled hypertension

            Hormone sensitivity cancer

            Diabetes mellitus with vascular involvement

            Jaundice with prior oral contraceptive use

            Pregnancy or suspicion of pregnancy

            Postpartum endometritis or infected abortion in the past 3 months

            Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear, or progestin sensitive cancer

            Conditions associated with increased susceptibility to pelvic infections

            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

            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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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.