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 decreases to ~10 mcg/day after 5 years and 8 mcg/day after 7 years
  • Remove by 7 years following insertion and replace if continuing treatment

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

Heavy Menstrual Bleeding

Indicated for heavy menstrual bleeding for up to 5 years in women who choose to use intrauterine contraception as a method of contraception

Initial levonorgestrel release rate is 20 mcg/day; rate reduced by 50% after 5 years

Replace after the end of fifth year if continued treatment needed

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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            Contraindicated (0)

              Serious - Use Alternative (27)

              • abametapir

                abametapir will increase the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • antithrombin alfa

                levonorgestrel intrauterine, antithrombin alfa. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • antithrombin III

                levonorgestrel intrauterine, antithrombin III. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • apalutamide

                apalutamide will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • argatroban

                levonorgestrel intrauterine, argatroban. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • bemiparin

                levonorgestrel intrauterine, bemiparin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • bivalirudin

                levonorgestrel intrauterine, bivalirudin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • cobicistat

                cobicistat will increase the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • dabrafenib

                dabrafenib will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • dalteparin

                levonorgestrel intrauterine, dalteparin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • elagolix

                levonorgestrel intrauterine decreases effects of elagolix by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Based on the mechanism of action of elagolix, estrogen-containing contraceptives are expected to reduce elagolix efficacy. Effects of progestin-only contraceptives on the efficacy of elagolix is unknown. Advise women to use nonhormonal contraceptives during treatment with elagolix and for 1 week after discontinuing elagolix.

              • encorafenib

                encorafenib will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of encorafenib with hormonal contraceptives (CYP3A4 substrates) can result in decreased concentrations and loss of hormonal contraceptive efficacy. Since encorafenib can cause fetal harm, advise women of childbearing potential to use a highly effective nonhormonal contraceptive during treatment and for 2 weeks after final encorafenib dose.

              • enoxaparin

                levonorgestrel intrauterine, enoxaparin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • fondaparinux

                levonorgestrel intrauterine, fondaparinux. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • heparin

                levonorgestrel intrauterine, heparin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • ivosidenib

                ivosidenib will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • lesinurad

                lesinurad decreases effects of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Use additional methods of nonhormonal contraception. Do not rely on hormonal contraception alone when taking lesinurad.

              • lorlatinib

                lorlatinib will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • lumacaftor/ivacaftor

                lumacaftor/ivacaftor will decrease the level or effect of levonorgestrel intrauterine by unspecified interaction mechanism. Avoid or Use Alternate Drug. Avoid coadministration unless benefit outweighs risk. When coadministered, hormonal contraceptives are not a reliable method of effective birth control. Concomitant use may increase incidence of menstruation associated adverse effects (amenorrhea, dysmenorrhea, menorrhagia).

              • mifepristone

                mifepristone will increase the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

              • nelfinavir

                nelfinavir will increase the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • perampanel

                perampanel will decrease the level or effect of levonorgestrel intrauterine by unspecified interaction mechanism. Avoid or Use Alternate Drug. Levonorgestrel levels reduced by 40% when coadministered with high dose perampanel (ie, 12 mg/day); effect on other progestins is unknown, consider back up contraception

              • phenindione

                levonorgestrel intrauterine, phenindione. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • protamine

                levonorgestrel intrauterine, protamine. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              • ritonavir

                ritonavir will increase the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              • sugammadex sodium

                sugammadex sodium decreases effects of levonorgestrel intrauterine by receptor binding competition. Avoid or Use Alternate Drug. In vitro binding studies showed that sugammadex may bind to progestogen, thereby decreasing progestogen exposure. Therefore, a sugammadex bolus dose is considered to be equivalent to missing dose(s) of hormonal contraceptives containing an estrogen or progestogen. If an oral contraceptive is taken on the same day of sugammadex, or the patient has a transdermal or implant hormonal contraceptive, the patient must use an additional, nonhormonal contraceptive method or back-up method of contraception (eg, condoms and spermicides) for the next 7 days.

              • warfarin

                levonorgestrel intrauterine, warfarin. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Risk of thromboembolic disorders.

              Monitor Closely (40)

              • amobarbital

                amobarbital will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • atazanavir

                atazanavir, levonorgestrel intrauterine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Atazanavir may increase or decrease levels of levonorgestrel. Use alternatives if available.

              • bosentan

                bosentan decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • carbamazepine

                carbamazepine decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • cenobamate

                cenobamate will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

                cenobamate will decrease the level or effect of levonorgestrel intrauterine by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Advise women to use additional or alternative non-hormonal birth control when concomitantly using cenobamate with oral contraceptives.

              • clobazam

                clobazam will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Clobazam is a weak CYP3A4 inducer; effectiveness of hormonal contraceptives may be diminished when given concurrently with clobazam. Additional non-hormonal forms of contraception are recommended.

              • crofelemer

                crofelemer increases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.

              • cyclosporine

                levonorgestrel intrauterine, cyclosporine. Either increases levels of the other by decreasing metabolism. Use Caution/Monitor. Combined oral contraceptives containing EE may inhibit the metabolism and increase plasma concentrations of cyclosporine.

              • dexamethasone

                dexamethasone decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • efavirenz

                efavirenz decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • enzalutamide

                enzalutamide decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • eslicarbazepine acetate

                eslicarbazepine acetate will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Use additional or alternative nonhormonal birth control.

              • etravirine

                etravirine decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • felbamate

                felbamate decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • fosphenytoin

                fosphenytoin decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • griseofulvin

                griseofulvin decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • insulin degludec

                levonorgestrel intrauterine decreases effects of insulin degludec by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.

              • insulin degludec/insulin aspart

                levonorgestrel intrauterine decreases effects of insulin degludec/insulin aspart by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.

              • insulin inhaled

                levonorgestrel intrauterine decreases effects of insulin inhaled by pharmacodynamic antagonism. Use Caution/Monitor. Progestins may impair glucose tolerance.

              • lamotrigine

                levonorgestrel intrauterine will decrease the level or effect of lamotrigine by increasing hepatic clearance. Use Caution/Monitor. Combination oral contraceptives have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation.

              • maraviroc

                levonorgestrel intrauterine increases levels of maraviroc by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity.

              • metformin

                levonorgestrel intrauterine decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.

              • mifepristone

                mifepristone decreases effects of levonorgestrel intrauterine by pharmacodynamic antagonism. Use Caution/Monitor. Backup contraceptive method recommended.

              • mitotane

                mitotane will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor; use of nonhormonal contraceptive may be necessary

              • nafcillin

                nafcillin decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • nevirapine

                nevirapine decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • oxcarbazepine

                oxcarbazepine decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • pentobarbital

                pentobarbital decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • phenobarbital

                phenobarbital decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • phenytoin

                phenytoin decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • primidone

                primidone decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ribociclib

                ribociclib will increase the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifabutin

                rifabutin decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifampin

                rifampin decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • rifapentine

                rifapentine decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • secobarbital

                secobarbital will decrease the level or effect of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • St John's Wort

                St John's Wort decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • teriflunomide

                teriflunomide increases levels of levonorgestrel intrauterine by unknown mechanism. Use Caution/Monitor.

              • tesamorelin

                tesamorelin will decrease the level or effect of levonorgestrel intrauterine by altering metabolism. Use Caution/Monitor. Use alternative contraception

              • topiramate

                topiramate decreases levels of levonorgestrel intrauterine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (0)

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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 (emergency 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; advise patient of isolated reports of virilization of the female fetus following local exposure to drug during pregnancy with an IUS in place

                Evaluate women for ectopic pregnancy; ~50% of pregnancies that occur with IUD are likely to be ectopic; also consider possibility of ectopic pregnancy in case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding

                Severe infection, including group A streptococcal sepsis reported

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

                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

                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

                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

                Women who currently have or have had breast cancer, or have a suspicion of breast cancer, should not use hormonal contraception, because some breast cancers are hormone-sensitive

                Product not intended for use in menopausal women

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

                Ovarian cysts may occur

                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

                Pelvic infection

                • PID may be asymptomatic but still result in tubal damage and its sequelae
                • Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores; remove device in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment
                • IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion
                • PID is often associated with a sexually transmitted infection (STI), and Mirena does not protect against STI; risk of PID is greater for women who have multiple sexual partners, and also for women whose sexual partner(s) have multiple sexual partners
                • Women who have had PID are at increased risk for a recurrence or re-infection; in particular, ascertain whether woman is at increased risk of infection (for example, leukemia, acquired immune deficiency syndrome [AIDS], intravenous drug abuse)
                • Following a diagnosis of PID, or suspected PID, obtain bacteriologic specimens and initiate antibiotic therapy promptly; removal of device after initiation of antibiotic therapy is usually appropriate

                Perforation

                • 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
                • Risk of uterine perforation is increased in women who have recently given birth, and in women who are breastfeeding at time of insertion and during postpartum period; risk of perforation may be increased if device is inserted when the uterus is fixed, retroverted or not completely involuted
                • Perforation may also occur at any time during IUS use and may reduce contraceptive efficacy and result in pregnancy; this may be associated with severe pain and continued bleeding
                • If perforation occurs, locate, and remove device; surgery may be required; delayed detection or removal of device in case of perforation may result in migration outside uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses and erosion of adjacent viscera

                Bleeding pattern alterations

                • Device can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea; during first 3–6 months of use, number of bleeding and spotting days may be higher and bleeding patterns may be irregular
                • Thereafter number of bleeding and spotting days usually decreases but bleeding may remain irregular; if bleeding irregularities develop during prolonged treatment, take appropriate diagnostic measures to rule out endometrial pathology
                • Amenorrhea develops in approximately 20% of device users by one year
                • Consider possibility of pregnancy if menstruation does not occur within six weeks of onset of previous menstruation; once pregnancy has been excluded, repeated pregnancy tests are generally not necessary in amenorrheic women unless indicated, for example, by other signs of pregnancy or by pelvic pain
                • In most women with heavy menstrual bleeding, the number of bleeding and spotting days may also increase during initial months of therapy but usually decrease with continued use; the volume of blood loss per cycle progressively becomes reduced

                Expulsion

                • Partial or complete expulsion of intrauterine device may occur resulting in loss of contraceptive protection; expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed
                • Drug typically decreases menstrual bleeding over time; an increase of menstrual bleeding may be indicative of an expulsion
                • Consider further diagnostic imaging, such as x-ray, if expulsion is suspected based on ultrasound
                • Risk of expulsion is increased with insertions immediately after delivery and appears to be increased with insertion after second-trimester abortion based on limited data; in a large postmarketing safety study conducted in US, risk of expulsion was lower with breastfeeding status
                • Remove a partially expelled device; if expulsion has occurred, a new device can be inserted any time the provider can be reasonably certain the woman is not pregnant
                • A 5-year expulsion rate of 3.5% (59 out of 1,690 subjects) reported in clinical trials; delay insertion a minimum of 4 weeks or until uterine involution complete following a delivery or a second-trimester abortion

                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

                Drug interaction overview

                • Drug interactions not studied; drugs or herbal products that induce or inhibit drug metabolizing enzymes, including CYP3A4, may decrease or increase, respectively, the serum concentrations of drug during use; however, contraceptive effect of drug is mediated via direct release of drug into uterine cavity and is unlikely to be affected by drug interactions via enzyme induction or inhibition
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                Pregnancy & Lactation

                Pregnancy

                Contraindicated in pregnancy or suspected pregnancy

                If a females becomes pregnant with IUD in place, risk of ectopic pregnancy is increased as well as miscarriage, sepsis, premature labor, and premature delivery

                Isolated cases of virilization of external genitalia of female fetus following exposure to levonorgestrel during pregnancy with a levonorgestrel intrauterine device in place

                Remove IUD, if possible, if pregnancy occurs in a woman using IUD

                If a woman becomes pregnant with levonorgestrel intrauterine device in place and the woman chooses not to have it removed or can’t be removed, advise her of reports of virilization of the female fetus following local exposure to levonorgestrel during pregnancy; closely follow pregnancy

                Female and male reproductive potential

                • Probability to conceive within 12 months after removal of intrauterine system reported to be approximately 77%

                Lactation

                Published studies report presence of LNG in human milk

                Small amounts of progestins (~0.1% of the total maternal doses) were detected in the breast milk of nursing mothers who used other LNG-releasing IUSs, resulting in exposure of LNG to the 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 have been reported with a LNG-releasing IUS

                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

                Local mechanism by which continuously released LNG enhances contraceptive effectiveness has not been demonstrated

                Suggested mechanisms of preventing pregnancy are thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium

                Absorption

                LNG concentrations

                • Kyleena
                  • 12 months: 199 pg/mL
                  • 24 months: 120 pg/mL
                  • 36 months: 122 pg/mL
                  • 48 months: 79 pg/mL
                  • 60 months: 65 pg/mL
                • Liletta
                  • 6 months: 195 pg/mL
                  • 12 months: 168 pg/mL
                  • 24 months: 150 pg/mL
                  • 36 months: 132 pg/mL
                  • 48 months: 114 pg/mL
                  • 60 months: 101 pg/mL
                  • 72 months: 93 pg/mL
                • Mirena
                  • 12 months: 150 pg/mL
                  • 24 months: 192 pg/mL
                  • 60 months: 159 pg/mL
                  • 72 months: 121 pg/mL
                • Skyla
                  • 12 months: 7 pg/mL
                  • 24 months: 62 pg/mL
                  • 36 months: 72 pg/mL

                Distribution

                Vd: ~1.8 L//kg

                Protein-bound

                • Mirena: ~97.5-99%
                • Liletta: ~98.9%

                Metabolism

                LNG conjugates to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in serum

                Also, studies demonstrated oxidative metabolism of LNG catalyzed by CYP enzymes, especially CYP3A4

                Elimination

                Clearance

                • Skyla and Kyleena: 1 mL/min/kg

                Half-life

                • Mirena: ~17 hr
                • Skyla: ~ 20 hr
                • Liletta: ~13.9 hr
                • Kyleena: ~20 hr

                Excretion

                • All formulations: ~45% (urine); ~32% (feces)
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                Administration

                Intrauterine Administration

                See prescribing information for full instructions

                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

                All formulations

                • Protect from light
                • Store at 25ºC (77ºF); excursions permitted to 15–30ºC (59–86ºF)
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                levonorgestrel oral
                -
                1.5 mg tablet
                Aftera oral
                -
                1.5 mg tablet
                Aftera oral
                -
                1.5 mg tablet
                Opcicon One-Step oral
                -
                1.5 mg tablet
                After Pill oral
                -
                1.5 mg tablet
                Plan B One-Step oral
                -
                1.5 mg tablet
                Plan B One-Step oral
                -
                1.5 mg tablet
                My Choice oral
                -
                1.5 mg tablet
                My Way oral
                -
                1.5 mg tablet
                Econtra One-Step oral
                -
                1.5 mg tablet
                Econtra One-Step oral
                -
                1.5 mg tablet
                Take Action oral
                -
                1.5 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Select a drug:
                Patient Education
                levonorgestrel oral

                LEVONORGESTREL 1.5 MG - ORAL

                (LEE-voe-nor-JES-trel)

                COMMON BRAND NAME(S): Plan B One-Step

                USES: Levonorgestrel is used by women to prevent pregnancy after birth control failure (such as a broken condom) or unprotected sex. This medication is an emergency contraceptive and should not be used as a regular form of birth control. It is a progestin hormone that works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg.Using this medication will not stop an existing pregnancy or protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).This medication may not work well in women over a certain weight (for example, greater than 164 pounds or 74 kilograms), or if you have used certain other medications within the past month. This effect can result in pregnancy. Talk to your doctor for more details and to see if this medication is right for you (see also Drug Interactions section).Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

                HOW TO USE: If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication. If you have any questions, talk to your pharmacist. If your doctor has prescribed this medication, take it as directed.Take 1 tablet by mouth with or without food as soon as possible after unprotected sex. This medication works best when it is taken within 72 hours (3 days) after unprotected sex.If you vomit within 2 hours of taking this medication, contact your doctor to ask if you need to repeat the dose.After you take this medication, the time when your period comes and how much you bleed may change. Tell your doctor right away if your period is more than 7 days late. You may need to take a pregnancy test.If you think you may have a serious medical problem, get medical help right away.

                SIDE EFFECTS: Nausea/vomiting, abdominal pain, tiredness, dizziness, changes in vaginal bleeding, breast tenderness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: severe lower stomach pain (especially 3 to 5 weeks after taking levonorgestrel).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before taking levonorgestrel, tell your doctor or pharmacist if you are allergic to it; or to other progestins (such as norethindrone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: unexplained vaginal bleeding.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some drugs may cause emergency birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others. Talk to your doctor or pharmacist for more details (see also Uses section).

                OVERDOSE: Overdose with this medication is very unlikely. However, if someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting.

                NOTES: Keep all regular medical and laboratory appointments.

                MISSED DOSE: Not applicable.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.