Contraception:
Initiation of therapy: In patients not currently using a hormonal contraceptive or intrauterine contraception, the IUD may be inserted into the uterine cavity at any time during the menstrual cycle once it is determined that the patient is not pregnant. Back-up contraception is not needed if insertion is within 7 days of onset of menstruation. If insertion occurs >7 days after menstrual bleeding started, a barrier method of contraception must be used for 7 days unless the patient abstains from sexual intercourse.
Continuation of therapy: When it is time to replace, IUD may be removed and replaced as follows with a new device immediately, and at any time during menstrual cycle as long as the patient is not pregnant:
Kyleena: Replace by the end of 5 years. Initially releases levonorgestrel ~17.5 mcg/day after 24 days, then rate subsequently decreases; the average release rate over 5 years is levonorgestrel ~9 mcg/day. Do not leave device in place for >5 years.
Liletta: Replace by the end of 6 years. Initially releases levonorgestrel 20 mcg/day, then rate subsequently decreases; the average release rate over 6 years is levonorgestrel ~14.3 mcg/day. Do not leave in place for >6 years.
Mirena: Replace by the end of 7 years. Initially releases levonorgestrel 20 mcg/day, then rate subsequently decreases to half of that after 5 years and 8 mcg/day after 7 years. Do not leave device in place for >7 years.
Skyla, Jaydess [Canadian product]: Replace by the end of 3 years. Initially releases levonorgestrel ~14 mcg/day after 24 days, then rate subsequently decreases; mean release rate over 3 years is levonorgestrel ~6 mcg/day. Do not leave device in place for >3 years.
|
Current method |
Instructions for switching to levonorgestrel IUD |
|---|---|
|
a When switching from a copper IUD, if sexual intercourse occurred after the start of the current cycle, and it has been >5 days since bleeding began, consider administering an emergency contraceptive (CDC [Curtis 2016a]). | |
|
Hormonal contraceptive (oral, transdermal, vaginal) |
Levonorgestrel IUD may be inserted anytime, including hormone-free interval of the previous method. If inserted during active use of the previous method, continue previous method for 7 days after insertion or until the end of the current treatment cycle. If using continuous hormonal contraception, continue previous method for 7 days after insertion. |
|
Injectable progestin |
Levonorgestrel IUD may be inserted at any time. If inserted >13 weeks after the last injection, a barrier method of contraception should also be used for 7 days. |
|
Implant or another intrauterine system (IUS)a |
Levonorgestrel IUD may be inserted on the same day the implant or IUS is removed, any time during the menstrual cycle. |
Switching from levonorgestrel IUD to a different contraceptive: If the patient wishes to change to a different method of birth control, remove IUD during the first 7 days of menstrual cycle and begin the new therapy. If the IUD is not removed during the first 7 days of menstruation (or if the patient has irregular menstrual cycles or amenorrhea), start the new method at least 7 days prior to IUD removal, otherwise, a back-up barrier contraceptive should be used for 7 days after the IUD is removed unless the patient abstains from vaginal intercourse.
|
a Product labeling recommends insertion following removal of the placenta, or waiting at least 6 weeks following delivery, or until the uterus is fully involuted. According to evidence-based guidelines, insertion postpartum (immediate insertion within 10 minutes of placental delivery or interval insertion during the 6-week postpartum period) or following an abortion are safe despite a higher risk of expulsion immediately postpartum or following a second trimester abortion and may be offered regardless of breastfeeding status to help prevent rapid repeat and unintended pregnancies (ACOG 2017; CDC [Curtis 2016b]). | |
|
b Back up contraception is needed for 7 days unless IUD is placed at the time of surgical abortion. Do not administer immediately following a septic abortion (CDC [Curtis 2016a]). | |
|
Use after childbirth (immediate) |
Levonorgestrel IUD may be inserted after removal of the placenta; backup contraception is not needed.a |
|
Use after childbirth (interval insertion following complete involution of the uterus) |
Levonorgestrel IUD should not be started <6 weeks after childbirth or until the uterus is fully involuted.a The IUD may be inserted anytime if it is determined that the patient is not pregnant. If menstruation has not yet resumed, consider the possibility of ovulation and conception occurring prior to IUD insertion. Back-up contraception is not needed if insertion is within 7 days of onset of menstruation. If insertion occurs >7 days after menstrual bleeding started, a barrier method of contraception must be used for 7 days unless the patient abstains from sexual intercourse. The risk of perforation is increased in lactating patients. |
|
Use after first trimester abortion or miscarriageb |
Levonorgestrel IUD may be inserted immediately after a first-trimester abortion or miscarriage. |
|
Use after second trimester abortion or miscarriageb |
Refer to instructions for use after childbirth. |
Dysmenorrhea (off-label use): 52 mg device: Refer to dosing for "Contraception" (ACOG 2018).
Endometrial hyperplasia, treatment (off-label use): 52 mg device: Insert into the intrauterine cavity for hyperplasia without atypia or atypical endometrial hyperplasia/endometrial intraepithelial neoplasia. IUDs that contain levonorgestrel 52 mg in a reservoir initially release ~20 mcg/day then progressively decrease to ~10 mcg/day after 5 years and should be replaced after 5 years; however, the optimal duration of treatment is not known (ACOG 2015; Armstrong 2012; Orbo 2014; Trimble 2012).
Heavy menstrual bleeding: Mirena: Refer to dosing for "Contraception." Do not leave device in place for >5 years.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use of the intrauterine device is contraindicated with active hepatic disease or hepatic tumor.
(For additional information see "Levonorgestrel intrauterine device: Pediatric drug information")
Contraception (Kyleena, Liletta, Mirena, Skyla, Jaydess ) or heavy menstrual bleeding (Mirena ):
Postmenarche patients: Intrauterine device (IUD):
Initiation of therapy: In patients not currently using a hormonal contraceptive or intrauterine contraception, the IUD may be inserted into the uterine cavity at any time during the menstrual cycle once it is determined that the patient is not pregnant. Backup contraception is not needed if insertion is within 7 days of onset of menstruation. If insertion occurs >7 days after menstrual bleeding started, a barrier method of contraception must be used for 7 days unless the patient abstains from sexual intercourse.
Continuation of therapy: Duration of action is product-specific. When it is time to replace, the dated IUD is removed and replaced as follows with a new device immediately, and at any time during menstrual cycle as long as the patient is not pregnant:
Kyleena: Replace by the end of 5 years. Initially releases levonorgestrel ~17.5 mcg/day after 24 days, then rate subsequently decreases; the average release rate over 5 years is levonorgestrel ~9 mcg/day. Do not leave device in place for >5 years.
Liletta: Replace by the end of 6 years. Initially releases levonorgestrel 20 mcg/day, then rate subsequently decreases; the average release rate over 6 years is levonorgestrel ~14.3 mcg/day. Do not leave in place for >6 years.
Mirena: Replace by the end of 7 years. Initially releases levonorgestrel 20 mcg/day, then rate subsequently decreases to half of that after 5 years and 8 mcg/day after 7 years. Do not leave device in place for >7 years.
Skyla, Jaydess [Canadian product]: Replace by the end of 3 years. Initially releases levonorgestrel ~14 mcg/day after 24 days, then rate subsequently decreases; mean release rate over 3 years is levonorgestrel ~6 mcg/day. Do not leave device in place for >3 years.
|
Current Method |
Instructions for Switching to Levonorgestrel IUD |
|---|---|
|
a When switching from a copper IUD, if sexual intercourse occurred after the start of the current cycle, and it has been >5 days since bleeding began, consider administering an emergency contraceptive (CDC [Curtis 2016a]). | |
|
Hormonal contraceptive (oral, transdermal, vaginal) |
Levonorgestrel IUD may be inserted anytime, including hormone-free interval of the previous method. If inserted during active use of the previous method, continue previous method for 7 days after insertion or until the end of the current treatment cycle. If using continuous hormonal contraception, continue previous method for 7 days after insertion. |
|
Injectable progestin |
Levonorgestrel IUD may be inserted at any time. If inserted >13 weeks after the last injection, a barrier method of contraception should also be used for 7 days. |
|
Implant or another intrauterine system (IUS)a |
Levonorgestrel IUD may be inserted on the same day the implant or IUS is removed, any time during the menstrual cycle. |
Switching from levonorgestrel IUD to a different contraceptive: If the patient wishes to change to a different method of birth control, may remove the device during the first 7 days of menstrual cycle and begin the new therapy. If the device is not removed during the first 7 days of menstruation (or if the patient has irregular menstrual cycles or amenorrhea) and wants to start a different method of birth control, start the new method at least 7 days prior to device removal, otherwise, a backup barrier contraceptive should be used for 7 days after the device is removed unless the patient abstains from vaginal intercourse.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Postmenarche patients: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); use of the intrauterine device is contraindicated with active hepatic disease or hepatic tumor.
Not indicated for use in postmenopausal patients.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Intrauterine Device, Intrauterine:
Kyleena: 19.5 mg
Liletta (52 MG): 19.5 mcg/day
Mirena (52 MG): 20 mcg/24 hr
Skyla: 13.5 mg
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Intrauterine Device, Intrauterine:
Jaydess: 13.5 mg [DSC]
Kyleena: 19.5 mg
Mirena: 52 mg
To be inserted into the uterine cavity. Consider administering analgesics or cervical anesthetic prior to insertion. Insert into the uterine cavity to the recommended depth with the provided insertion device; should not be forced into the uterus. If necessary, dilate the cervical canal and consider using a paracervical block. Transvaginal ultrasound may be used to check proper placement. Remove if not positioned properly and insert a new IUD; do not reinsert removed IUD. Exclude uterine perforation if exceptional pain or bleeding occurs after insertion. Ensure device is intact after removal. Check expiration of IUD prior to insertion. Use of the provided inserter and directions for insertion are different for immediate insertion after childbirth or second-trimester abortion, or miscarriage. Refer to manufacturer's labeling for additional administration instructions.
Because testosterone may cause vaginal atrophy, consider pretreating with vaginal estrogen for 2 weeks prior to insertion to patients on gender-affirming testosterone therapy (Bonnington 2020).
Dysmenorrhea (off-label use): 52 mg device: Consider placing IUD during diagnostic laparoscopy to minimize pain of insertion for patients undergoing this procedure (ACOG 2018).
In case of breakage or embedment of IUD in the myometrium, analgesia, paracervical anesthesia, cervical dilation, alligator forceps, or hysteroscopy may be used to aid in removal.
Intrauterine device (IUD): To be inserted into the uterine cavity by a health care professional. Consider administering analgesics or cervical anesthetic prior to insertion. Insert into the uterine cavity to the recommended depth with the provided insertion device; should not be forced into the uterus. If necessary, dilate the cervical canal and consider using a paracervical block. Transvaginal ultrasound may be used to check proper placement. Remove if not positioned properly and insert a new IUD; do not reinsert removed IUD. Exclude uterine perforation if exceptional pain or bleeding occurs after insertion. Ensure device is intact after removal. Check expiration of IUD prior to insertion. Refer to manufacturer's labeling for additional administration instructions. For patients on gender-affirming testosterone therapy, consider pretreating with vaginal estrogen for 2 weeks prior to insertion because testosterone may cause vaginal atrophy (Bonnington 2020). In case of breakage or embedment of IUD in the myometrium, analgesia, paracervical anesthesia, cervical dilation, alligator forceps, or hysteroscopy may be used to aid in removal.
Hazardous agent (NIOSH 2016 [group 2]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single) should be worn during receiving, unpacking, and placing in storage. Double gloving and a protective gown are recommended for administration (NIOSH 2016). Assess risk to determine appropriate containment strategy (USP-NF 2017).
Contraception: Prevention of pregnancy (up to 3 years [Skyla], 5 years [Kyleena], 6 years [Liletta], or 7 years [Mirena]).
Limitations of use: For use in patients who may become pregnant; not for use prior to menarche or post menopause.
Heavy menstrual bleeding (Mirena only): Treatment of heavy menstrual bleeding for up to 5 years in patients who also choose to use an IUD for contraception.
Dysmenorrhea; Emergency contraception; Endometrial hyperplasia (treatment); Menstrual suppression
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adolescents and adults.
>10%:
Dermatologic: Acne vulgaris (7% to 15%)
Endocrine & metabolic: Amenorrhea (≤40%; increases with duration of treatment), ovarian cyst (5% to 22%)
Gastrointestinal: Abdominal pain (≤23%)
Genitourinary: Bacterial vaginosis (19%), gynecological bleeding (including decreased, increased, heavy, irregular, prolonged, unscheduled, frequent and infrequent uterine bleeding), pelvic pain (≤23%), vaginal discharge (4% to 15%), vulvovaginitis (11% to 24%)
Infection: Vaginal mycosis (19%)
Nervous system: Headache (≤16%), migraine (≤16%)
1% to 10%:
Dermatologic: Alopecia (1%), seborrhea (1% to 2%)
Endocrine & metabolic: Hirsutism (<5%), weight gain (6%)
Gastrointestinal: Abdominal distress, nausea, vomiting
Genitourinary: Breast tenderness (including discomfort: ≤10%), dysmenorrhea (6% to 9%), dyspareunia (9%), endometritis (≤2%), mastalgia (≤10%), pelvic inflammatory disease (<5%), uterine spasm (2%)
Infection: Bacterial reproductive infection (1% to 4%)
Nervous system: Anxiety (9%), depressed mood (≤6%), depression (≤8%), mood changes (6%)
Neuromuscular & skeletal: Back pain (6% to 8%)
Miscellaneous: Female birth control expulsion from the genital tract (3% to 5%; partial and complete)
<1%: Genitourinary: Ectopic pregnancy, uterine perforation
Postmarketing:
Cardiovascular: Arterial thromboembolism, cerebrovascular accident, deep vein thrombosis, increased blood pressure, pulmonary embolism, venous thromboembolism
Hematologic & oncologic: Malignant neoplasm of breast
Hypersensitivity: Angioedema, hypersensitivity reaction
Infection: Sepsis (including Group A streptococcal sepsis), severe infection
Miscellaneous: Breakage of IUD
Hypersensitivity to levonorgestrel or any component of the formulation; pregnancy or suspected pregnancy; postcoital contraception; congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity and would be incompatible with correct IUD placement; acute pelvic inflammatory disease or history of pelvic inflammatory disease (unless there has been a subsequent intrauterine pregnancy); postpartum endometritis or infected abortion within past 3 months; known or suspected uterine or cervical malignancy; untreated acute cervicitis or vaginitis (including bacterial vaginosis, known chlamydial or gonococcal cervical infection) or other lower genital tract infections until infection is controlled; conditions which increase susceptibility to pelvic infections; unremoved IUD; uterine bleeding of unknown etiology; acute hepatic disease or hepatic tumors (benign or malignant); current or history of known or suspected breast cancer or other hormone-sensitive cancer.
Canadian labeling: Additional contraindications (not in US labeling): Bacterial endocarditis; recent trophoblastic disease while human chorionic gonadotropin (hCG) hormone levels are elevated; cervical dysplasia; known immunodeficiency or hematologic malignancy (Mirena)
Concerns related to adverse effects:
• Bleeding irregularities: Menstrual bleeding patterns may be altered, especially during the first 3 to 6 months with use of the intrauterine device (IUD) and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea, and amenorrhea; the possibility of pregnancy should be considered if menstruation does not occur within 6 weeks of the previous menstrual period. If significant bleeding irregularities continue with prolonged use, conduct diagnostic tests to assess possible endometrial pathology (polyps or cancer). An increase in menstrual bleeding may indicate a partial or complete expulsion of the IUD (see dosage form specific issues). Unexplained vaginal bleeding should be evaluated prior to insertion (CDC [Curtis 2016b]). Exclude endometrial polyps or cancers in patients with persistent or unexplained vaginal bleeding.
• Bradycardia/syncope: Bradycardia or syncope may occur during insertion or removal of the IUD; use with caution in patients predisposed to these conditions.
• Ectopic pregnancy: Use caution in patients with previous ectopic pregnancy. Patients with history of ectopic pregnancy were excluded from clinical trials; patients with previous ectopic pregnancy, tubal surgery, or pelvic infection may be at increased risk for ectopic pregnancy. The possibility of ectopic pregnancy should be considered in patients with lower abdominal pain, especially in association with missed periods or new-onset vaginal bleeding in patients with prior amenorrhea. Ectopic pregnancy may result in loss of fertility.
• Ovarian cysts: May occur during IUD use; most are asymptomatic and disappear spontaneously within 2 to 3 months. Evaluate if persistent.
• Pelvic inflammatory disease: An increased incidence of group A streptococcal sepsis, pelvic inflammatory disease (PID) or endometritis (may be asymptomatic), and actinomycosis has been reported with use. Using aseptic technique during insertion is essential to minimizing the risk of serious infections. PID occurs more frequently within the first year and most often within the first month after insertion; risk is increased with multiple sexual partners. Patients with a history of PID or endometritis are at increased risk. If PID is diagnosed, treat according to current guidelines and reassess in 48 to 72 hours. If there is no clinical improvement, continue antibiotics and consider removal of device (CDC [Curtis 2016a]). Patients with symptomatic actinomycosis should have the device removed and be treated with the appropriate antibiotics. Remove IUD in cases of recurrent endometritis or PID, or if an acute pelvic infection is severe or does not respond to treatment.
• Seizure: Insertion or removal may be associated with seizure, especially in patients predisposed to seizures.
Disease-related concerns:
• Cervical or endometrial cancer: Patients diagnosed with cervical or endometrial cancer prior to IUD insertion should not use an IUD for pregnancy prevention (may have in increased risk of bleeding or infection when the device is inserted). Patients diagnosed after insertion of an IUD may continue; however, the IUD will most likely need to be removed during treatment (CDC [Curtis 2016b]).
• Depression: Use with caution in patients with depression; may be more susceptible to recurrence of depressive episodes; consider removal of IUD for serious recurrence. Depression is not a contraindication to use of the IUD (CDC [Curtis 2016b]).
• Gestational trophoblastic disease: Patients with gestational trophoblastic disease are at increased risk of adverse events if pregnancy occurs; use of the levonorgestrel IUD may be appropriate for prevention of pregnancy in some situations with close medical supervision. However, patients with persistently elevated beta-hCG concentrations or malignant disease with evidence or suspicion of intrauterine disease should not initiate therapy with a levonorgestrel IUD due to risks of infection, hemorrhage, or perforation. Consider benefits of effective contraception versus risks of continuation/removal in patients who have a levonorgestrel IUD already in place (CDC [Curtis 2016b]).
• Sepsis: The levonorgestrel IUD should not be inserted in patients with postpartum sepsis or immediately following a septic abortion (CDC [Curtis 2016b]).
• Sexually transmitted disease: Use of the levonorgestrel IUD should not be initiated in patients with purulent cervicitis, chlamydial, or gonococcal infection. The IUD does not need to be removed if diagnosis occurs with the IUD in place, as long as there is treatment with appropriate antibiotics, symptoms resolve, and consideration is given to personal risk factors and patient preference (CDC [Curtis 2016a]; CDC [Curtis 2016b]).
• Tuberculosis: The levonorgestrel IUD may be inserted in patients with nonpelvic tuberculosis; do not initiate treatment in cases of pelvic infection and consider removal when pelvic infection occurs with the IUD in place (CDC [Curtis 2016b]).
Special populations:
• Body weight: Clinical trials did not exclude patients based on BMI (CDC [Curtis 2016a]).
• Smoking: The risk of cardiovascular side effects increases in patients using estrogen containing combined hormonal contraceptives and who smoke cigarettes, especially those who are >35 years of age. This risk relative to progestin-only contraceptives has not been established. Patients who take combination hormonal contraceptives should be advised not to smoke. Smoking is not a contraindication to use of the IUD (CDC [Curtis 2016b]).
Dosage form specific issues:
• Consent form: Some products provide a consent form; a copy of the form and lot number should be kept with the patient's medical record.
• Expulsion: Partial or complete expulsion may occur; may be associated with symptoms of bleeding or pain or may be asymptomatic and go unnoticed. An increase in menstrual bleeding may indicate a partial or complete expulsion of the IUD. If the IUD is not found in the uterus, consider further testing to confirm expulsion (eg, sonography, X-ray). The risk of expulsion may be increased when inserted immediately after delivery or after second-trimester abortion. If expulsion occurs, remove device; may replace device any time the health care professional assesses that the patient is not pregnant.
• MRI: Only under specific conditions may an IUD be scanned safely by MRI (refer to manufacturer's labeling for requirements). Image quality may also be impaired if area of interest is relatively close to the device.
• Perforation: Total or partial perforation may occur, most often during insertion but can occur at any time during use. Perforation may include penetration/embedment in the uterus or cervix; risk of perforation is increased in patients who are lactating, ≤6 weeks postpartum, or when the uterus is fixed, retroverted, or not completely involuted when the device is inserted. Perforation may reduce contraceptive efficacy and result in pregnancy. If perforation occurs, locate and remove IUD; delayed detection or removal in cases of perforation may result in migration of IUD outside of uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera.
Other warnings/precautions:
• Appropriate use: IUD: Insertion should be done by a trained health care provider. Insertion and removal may be associated with pain and/or bleeding; consider analgesics prior to insertion. Removal of the device may be necessary for the following reasons: pelvic infection or disease, endometritis, symptomatic genital actinomycosis, uterine or cervical cancer, uterine or cervical perforation, partial expulsion, and pregnancy. Use with caution if any of the following conditions exist and consider removal if any of them arise during use: Coagulopathy or are receiving anticoagulants; marked increase of blood pressure; severe arterial disease, such as stroke or MI; exceptionally severe headache; and migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia. In addition, consider removal if jaundice occurs during use.
• HIV infection protection: Intrauterine devices do not protect against HIV infection or other sexually transmitted diseases (CDC [Curtis 2016b]).
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May diminish the therapeutic effect of Levonorgestrel (IUD). CYP3A4 Inducers (Strong) may decrease the serum concentration of Levonorgestrel (IUD). Risk C: Monitor therapy
Ulipristal: May diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Risk X: Avoid combination
Evaluate pregnancy status prior to insertion.
The device may be inserted into the uterine cavity at any time during the menstrual cycle once it is determined that the patient is not pregnant. The device may be inserted immediately following a first trimester-induced or spontaneous abortion. Following pregnancy or a second trimester induced or spontaneous abortion, insertion of the device may be done following removal of the placenta, or should not take place for at least 6 weeks or until involution of the uterus is complete. Insertion postpartum (immediate insertion within 10 minutes of placental delivery or interval insertion during the 6-week postpartum period) or following an abortion are safe despite a higher risk of expulsion immediately postpartum and following a second trimester abortion and may be offered regardless of breastfeeding status to help prevent rapid repeat and unintended pregnancies (ACOG 2017; CDC [Curtis 2016b]).
All available forms of contraception, including the levonorgestrel IUD, can be considered for patients on gender-affirming testosterone therapy after evaluating the appropriateness of the method based on the patient's preferences and medical conditions (Bonnington 2020; Krempasky 2020).
Following removal of the device, ~71% to 85% of patients who wished to conceive became pregnant within 12 months.
Use during pregnancy or a suspected pregnancy is contraindicated.
Patients who become pregnant with an IUD in place risk spontaneous or septic abortion; septicemia, septic shock, and death may occur. In addition, the likelihood of ectopic pregnancy is increased; miscarriage, sepsis, premature labor, and premature delivery may occur if pregnancy is continued. Removal of the device is recommended if strings are visible or removal can be done safely from the cervical canal. However, removal or manipulation of IUD or probing of the uterus may result in pregnancy loss. Use of an ultrasound should be considered to determine location of IUD prior to removal (CDC [Curtis 2016a]).
Virilization of the female fetus has been observed following exposure to the levonorgestrel IUD.
Levonorgestrel is present in breast milk.
Two studies evaluated levonorgestrel breast milk concentrations following IUD insertion among patients 4 to 6 weeks postpartum (Heikkilä 1982; Shikary 1987). In 1 study, there was no correlation between dose and maternal serum or milk concentrations, although the authors calculated the infants received a relative dose of 1.2% of the maternal dose (Heikkilä 1982). In both studies, the milk/plasma ratio increased over time during the 4- and 12-week study periods (Heikkilä 1982; Shikary 1987). Levonorgestrel was also detected in the serum of breastfeeding infants (Shikary 1987).
Concentrations of levonorgestrel and fat content in breast milk are similar 4 to 8 weeks after initial IUD insertion regardless if placement occurs immediately after delivery or at the first postpartum visit (4 to 8 weeks after delivery) (Hopelian 2021). The onset of lactogenesis and the duration of breastfeeding were not found to be influenced by the time of initial IUD placement (immediately after delivery or 4 to 8 weeks postpartum) (Turok 2017).
In general, no adverse effects on the growth or development if the infant have been observed. Isolated cases of decreased milk production have been reported.
Maternal plasma concentrations of levonorgestrel are dependent upon sex hormone binding globulin capacity, which is influenced by concomitant administration with estrogen or the postpartum status (Orme 1983). Risk of perforation with IUD is increased in patients who are lactating. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the patient.
Following pregnancy, insertion of the device may be done following removal of the placenta, or should not take place for at least 6 weeks postpartum or until involution of the uterus is complete. Levonorgestrel IUD may be inserted immediately postpartum in patients who are breastfeeding, including patients who had a cesarean delivery. The risk of infection is not increased; the risks of expulsion may be increased and this risk should be considered along with the need for effective contraception and patient access to placement at a later time (CDC [Curtis 2016b]).
Prior to insertion: Assessment of pregnancy status; bimanual examination and cervical inspection; weight (optional; BMI at baseline may be helpful to monitor changes during therapy); STD screen (unless already screened according to CDC STD Treatment guidelines) (CDC [Curtis 2016a]). Complete medical and social history which may determine conditions influencing an IUD use for contraception.
Following insertion: Transvaginal ultrasound may be used to check placement. Changes in health status (including medications) should be assessed at routine follow-up visits (CDC [Curtis 2016a]). Re-examine following insertion (4 to 6 weeks Kyleena, Liletta, Mirena, Skyla; 4 to 12 weeks Jaydess [Canadian product]) and then yearly or more frequently if necessary. Threads should be visible; if length of thread has changed device may have become displaced, broken, perforated the uterus, or expelled. Monitor for significant changes in menstrual bleeding during prolonged use, Pap smear, blood pressure, serum glucose in patients with diabetes. Patients presenting with lower abdominal pain should be evaluated for ovarian cysts and ectopic pregnancy. Signs of infection. Monitor for signs/symptoms of thromboembolism in patients who require surgery with prolonged immobilization.
Endometrial hyperplasia, treatment (off-label use): Endometrial sampling every 3 to 6 months, although most appropriate frequency has not been determined (ACOG 2015; Trimble 2012).
Kyleena: Plasma concentrations range from 175 ± 74 pg/mL (7 days following insertion) to 90 ± 35 pg/mL (after 5 years).
Liletta: Plasma concentrations range from a peak of 252 ± 123 pg/mL (7 days following insertion) to 93 ± 45 pg/mL (after 6 years).
Mirena: Plasma concentrations range from 150 to 200 pg/mL.
Skyla, Jaydess [Canadian product]: Plasma concentrations range from a peak of 192 pg/mL (2 days following insertion) to 59 to 61 pg/mL (after 3 years).
Pregnancy may be prevented through several mechanisms: Thickening of cervical mucus, which inhibits sperm passage through the uterus; inhibition of sperm survival; alteration of the endometrium. Inhibition of ovulation may also occur in some patients.
Duration: Prevention of pregnancy: Kyleena: Up to 5 years; Liletta: Up to 6 years; Mirena: Up to 7 years; Skyla, Jaydess [Canadian product]: Up to 3 years.
Distribution: Vd: ~1.8 L/kg.
Protein binding: Highly bound to albumin (~50%) and sex hormone-binding globulin (~47%) (Fotherby 1995).
Metabolism: Hepatic via CYP3A4; forms inactive metabolites.
Excretion: Urine (~45%); feces (~32%).
Intrauterine Device (Kyleena Intrauterine)
19.5 mg (per each): $1,259.09
Intrauterine Device (Liletta (52 MG) Intrauterine)
19.5 mcg/day (per each): $1,014.12
Intrauterine Device (Mirena (52 MG) Intrauterine)
20 mcg/24 hrs (per each): $1,259.09
Intrauterine Device (Skyla Intrauterine)
13.5 mg (per each): $1,048.40
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