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Levonorgestrel (IUD)

Pronunciation

Pronunciation

(LEE voe nor jes trel)

Index Terms

  • LNg 20

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Intrauterine Device, Intrauterine:

Liletta (52 MG): 18.6 mcg/day

Mirena (52 MG): 20 mcg/24 hr

Skyla: 13.5 mg

Brand Names: U.S.

  • Liletta (52 MG)
  • Mirena (52 MG)
  • Skyla

Pharmacologic Category

  • Contraceptive
  • Progestin

Pharmacology

Pregnancy may be prevented through several mechanisms: Thickening of cervical mucus, which inhibits sperm passage through the uterus and sperm survival; inhibition of ovulation, from a negative feedback mechanism on the hypothalamus, leading to reduced secretion of follicle stimulating hormone (FSH) and luteinizing hormone (LH); altering the endometrium, which may affect implantation. Levonorgestrel is not effective once the implantation process has begun.

Distribution

Vd: ~1.8 L/kg

Metabolism

Hepatic via CYP3A4; forms inactive metabolites

Excretion

Urine (45%); feces (32%)

Duration of Action

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

Protein Binding

Highly bound to albumin (~50%) and sex hormone-binding globulin (~47%) (Fotherby 1995)

Use: Labeled Indications

Contraception: Prevention of pregnancy

Heavy menstrual bleeding: Mirena: Treatment of heavy menstrual bleeding in women who also choose to use an IUD for contraception

Contraindications

Hypersensitivity to levonorgestrel or any component of the formulation; pregnancy; postcoital contraception, congenital or acquired uterine anomaly including fibroids that distort the uterine cavity, acute pelvic inflammatory disease, 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 neoplasia, 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, undiagnosed uterine bleeding, acute hepatic disease or hepatic tumors, current or history of known or suspected carcinoma of the breast or other progestin-sensitive cancer

Canadian labeling: Additional contraindications (not in US labeling): Bacterial endocarditis, known immunodeficiency, hematologic malignancy, recent trophoblastic disease while human chorionic gonadotropin (hCG) hormone levels are elevated; cervical dysplasia

Dosing: Adult

Contraception: Females: Intrauterine device: To be inserted into uterine cavity.

Liletta: Releases levonorgestrel ~15.6 mcg per day over 3 years. Do not leave device in place for >3 years.

Skyla, Jaydess [Canadian product]: Releases levonorgestrel ~6 mcg per day over 3 years. Do not leave device in place for >3 years.

Mirena: Initially releases levonorgestrel 20 mcg per day, then rate subsequently decreases; mean release rate over 5 years is levonorgestrel ~14 mcg per day. Do not leave device in place for >5 years.

Initiation of therapy: The device may be inserted at any time in the menstrual cycle once it is determined that the woman is not pregnant. Back-up contraception is not needed if insertion is within 7 days of onset of menstruation or immediately after first trimester abortion or miscarriage. Following pregnancy or a second trimester abortion or miscarriage, insertion of the device should not take place until 6 weeks postpartum or until involution of the uterus is complete. Do not administer immediately following a septic abortion. If insertion occurs >7 days after menstrual bleeding started, an additional form of contraception must be used for 7 days unless the woman abstains from sexual intercourse (CDC 2013).

Continuation of contraception: When it is time to replace, device may be removed and replaced with a new device immediately, and at any time during menstrual cycle as long as the woman is not pregnant.

Switching from a different contraceptive to levonorgestrel IUD: The device may be inserted immediately if it is determined that the woman is not pregnant. Unless the woman abstains from sexual intercourse, a backup method of contraception is needed if it has been >7 days since menstrual bleeding has begun. When an additional method of contraception is needed, consider continuing the woman’s previous method for 7 days after insertion (CDC 2013).

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 2013).

Switching to Liletta from an injectable progestin contraceptive: May be inserted at any time. If inserted >13 weeks after the last injection, a barrier method of contraception should be used for 7 days.

Switching to Liletta from a contraceptive implant or another intrauterine system: May insert on the same day the implant or device is removed, any time during the menstrual cycle.

Switching to Liletta from a hormonal contraceptive (oral, transdermal, vaginal): May be inserted anytime, including hormone free interval. Continue previous method for 7 days or until the end of the current 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 back-up barrier contraceptive should be used for 7 days after the device is removed unless the woman abstains from vaginal intercourse.

Treatment of heavy menstrual bleeding: Females: Intrauterine device (Mirena): Refer to dosing for long-term prevention of pregnancy

Dosing: Geriatric

Not indicated for use in postmenopausal women.

Dosing: Pediatric

Long-term prevention of pregnancy, or treatment of heavy menstrual bleeding: Females: Refer to adult dosing. Not for use prior to menarche.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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.

Administration

Intrauterine device: 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.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Storage

Liletta: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

Mirena, Skyla: Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Drug Interactions

Acitretin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Given the potential for progestin-only preparations to fail to prevent pregnancy during acitretin therapy, such products should not be relied upon. Alternative, nonhormonal forms of contraception must be employed during acitretin therapy. Consider therapy modification

Anticoagulants: Progestins may diminish the therapeutic effect of Anticoagulants. More specifically, the potential prothrombotic effects of some progestins and progestin-estrogen combinations may counteract anticoagulant effects. Management: Carefully weigh the prospective benefits of progestins against the potential increased risk of procoagulant effects and thromboembolism. Use is considered contraindicated under some circumstances. Refer to related guidelines for specific recommendations. Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Aprepitant: May decrease the serum concentration of Contraceptives (Progestins). Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. Consider therapy modification

Artemether: May decrease the serum concentration of Contraceptives (Progestins). Management: Consider the use of an alternative (i.e., non-hormonal) means of contraception in all women of childbearing potential who are using artemether. Consider therapy modification

Atazanavir: May increase the serum concentration of Contraceptives (Progestins). However, atazanavir may lead to decreased ethinyl estradiol concentrations and decreased effectiveness of oral contraceptive products. Management: Consider an alternative or additional method of contraception, particularly with combined estrogen/progestin products. Depot medroxyprogesterone acetate may be used without a need for additional contraception. Consider therapy modification

Barbiturates: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Consider therapy modification

Bexarotene (Systemic): May decrease the serum concentration of Contraceptives (Progestins). Management: Women of childbearing potential receiving bexarotene should use two reliable forms of contraception (including at least one nonhormonal form). Consider therapy modification

Bile Acid Sequestrants: May decrease the serum concentration of Contraceptives (Progestins). Management: Administer oral progestin-containing contraceptives at least 1-4 hours prior to or 4-6 hours after administration of a bile acid sequestrant. Consider therapy modification

Boceprevir: May increase the serum concentration of Contraceptives (Progestins). This has been seen specifically with norethindrone. Boceprevir may increase the serum concentration of Contraceptives (Progestins). This has been seen specifically with drospirenone. Management: Patients receiving boceprevir, ribavirin, and peginterferon alfa should use two reliable forms of contraception. Norethindrone/ethinyl estradiol may be used for one of these when norethindrone dose is at least 1 mg/day. Avoid drospirenone. Consider therapy modification

Bosentan: May decrease the serum concentration of Contraceptives (Progestins). Management: Use an alternative (i.e., non-hormonal) means of contraception for all women of childbearing potential who are using bosentan, and do not rely on hormonal contraceptives alone. Consider therapy modification

C1 inhibitors: Progestins may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy

CarBAMazepine: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Consider therapy modification

Carfilzomib: May enhance the thrombogenic effect of Contraceptives (Progestins). Management: Consider alternative, non-hormonal methods of contraception in patients requiring therapy with carfilzomib. Consider therapy modification

CloBAZam: May decrease the serum concentration of Contraceptives (Progestins). Consider therapy modification

Cobicistat: May increase the serum concentration of Contraceptives (Progestins). Management: Consider an alternative, non-hormone-based contraceptive in patients receiving cobicistat-containing products. Consider therapy modification

Dabrafenib: May decrease the serum concentration of Contraceptives (Progestins). Management: Females of reproductive potential should use an alternative, highly effective, non-hormonal means of contraception during and at least 2 weeks (dabrafenib alone) or 4 months (dabrafenib + trametinib) after discontinuation of dabrafenib treatment. Consider therapy modification

Darunavir: May decrease the serum concentration of Contraceptives (Progestins). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate may be used without a need for additional contraception. Consider therapy modification

Efavirenz: May decrease the serum concentration of Contraceptives (Progestins). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification

Eslicarbazepine: May decrease the serum concentration of Contraceptives (Progestins). Management: Alternative, non-hormonal means of birth control should be considered for women of child-bearing potential. Consider therapy modification

Felbamate: May decrease the serum concentration of Contraceptives (Progestins). Management: Contraceptive failure is possible. Use of an alternative, nonhormonal method of contraception is recommended. Consider therapy modification

Flibanserin: Contraceptives (Progestins) may increase the serum concentration of Flibanserin. Monitor therapy

Fosamprenavir: Contraceptives (Progestins) may decrease serum concentrations of the active metabolite(s) of Fosamprenavir. Fosamprenavir may decrease the serum concentration of Contraceptives (Progestins). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate may be used without a need for additional contraception. Consider therapy modification

Fosaprepitant: May decrease the serum concentration of Contraceptives (Progestins). The active metabolite aprepitant is likely responsible for this effect. Management: Alternative or additional methods of contraception should be used both during treatment with aprepitant or fosaprepitant and for at least one month following the last aprepitant/fosaprepitant dose. Consider therapy modification

Fosphenytoin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Griseofulvin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Avoid combination

Herbs (Progestogenic Properties) (eg, Bloodroot, Yucca): May enhance the adverse/toxic effect of Progestins. Monitor therapy

LamoTRIgine: May decrease the serum concentration of Contraceptives (Progestins). Management: Women using progestin-only “minipill” products may be at risk for contraceptive failure; it is unclear if other progestin-containing products would be significantly impacted. Alternative, non-hormonal, means of contraception are recommended. Consider therapy modification

Lesinurad: May decrease the serum concentration of Contraceptives (Progestins). Management: Use of an additional, nonhormonal contraceptive is recommended in patients being treated with lesinurad who desire effective contraception. Consider therapy modification

Lixisenatide: May decrease the serum concentration of Contraceptives (Progestins). Management: Administer oral contraceptives 1 hour before or at least 11 hours after administration of lixisenatide. Consider therapy modification

Lopinavir: May decrease the serum concentration of Contraceptives (Progestins). Lopinavir may increase the serum concentration of Contraceptives (Progestins). Management: Consider using an alternative or additional means of contraception. Injected depot medroxyprogesterone acetate and etonogestrel implants may be used without a need for additional contraception. Consider therapy modification

Lumacaftor: May decrease the serum concentration of Contraceptives (Progestins). Management: Do not rely on hormone-based contraceptives with concurrent use of lumacaftor/ivacaftor; an alternative, non-hormonal, method of contraception should be used if this combination is required. Consider therapy modification

Metreleptin: May decrease the serum concentration of Contraceptives (Progestins). Metreleptin may increase the serum concentration of Contraceptives (Progestins). Monitor therapy

MiFEPRIStone: May diminish the therapeutic effect of Contraceptives (Progestins). MiFEPRIStone may increase the serum concentration of Contraceptives (Progestins). Management: Women of childbearing potential should use an effective, nonhormonal means of contraception during and 4 weeks following mifepristone treatment. Consider therapy modification

Mycophenolate: May decrease the serum concentration of Contraceptives (Progestins). Management: Use of an additional or alternative (nonhormonal) method of contraception should be considered. Consider therapy modification

Nelfinavir: May decrease the serum concentration of Contraceptives (Progestins). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification

Nevirapine: May decrease the serum concentration of Contraceptives (Progestins). Management: Instruct patients receiving nevirapine to use an alternative or additional nonhormonal contraceptive. Nevirapine product labeling however suggests that depo-medroxyprogesterone acetate may be used as a sole method of contraception. Consider therapy modification

OXcarbazepine: May decrease the serum concentration of Contraceptives (Progestins). Management: Contraceptive failure is possible. Use of an additional or alternative, nonhormonal method of contraception is recommended. Consider therapy modification

Perampanel: May decrease the serum concentration of Contraceptives (Progestins). Management: Patients should use an alternative, non-hormonal based form of contraception for the duration of concurrent perampanel. Both oral and non-oral progestin-based contraceptives are likely to be impacted by this interaction. Consider therapy modification

Phenytoin: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Pomalidomide: Progestins may enhance the thrombogenic effect of Pomalidomide. Management: Canadian pomalidomide labeling recommends caution with use of hormone replacement therapy and states that hormonal contraceptives are not recommended. US pomalidomide labeling does not contain these specific recommendations. Consider therapy modification

Primidone: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Use of alternative, nonhormonal contraceptives is recommended. Consider therapy modification

Prucalopride: May decrease the serum concentration of Contraceptives (Progestins). Consider therapy modification

Retinoic Acid Derivatives: May diminish the therapeutic effect of Contraceptives (Progestins). Retinoic Acid Derivatives may decrease the serum concentration of Contraceptives (Progestins). Management: Two forms of effective contraception should be used in patients receiving retinoic acid derivatives. Particularly, microdosed progesterone-only preparations may be inadequately effective. Exceptions: Adapalene; Bexarotene (Topical); Tretinoin (Topical). Consider therapy modification

Rifamycin Derivatives: May decrease the serum concentration of Contraceptives (Progestins). Contraceptive failure is possible. Management: Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Saquinavir: May decrease the serum concentration of Contraceptives (Progestins). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification

Selegiline: Contraceptives (Progestins) may increase the serum concentration of Selegiline. Monitor therapy

St John's Wort: May diminish the therapeutic effect of Contraceptives (Progestins). Contraceptive failure is possible. Management: Consider using a product other than St John's wort. Contraceptive failure is possible. Use of an alternative, nonhormonal contraceptive is recommended. Consider therapy modification

Sugammadex: May decrease the serum concentration of Contraceptives (Progestins). Management: Patients receiving any hormonal contraceptive (oral or non-oral) should use an additional, nonhormonal contraceptive method during and for 7 days following sugammadex treatment. Consider therapy modification

Telaprevir: May decrease the serum concentration of Contraceptives (Progestins). Management: Two different nonhormonal forms of contraception are required for women of childbearing potential taking telaprevir. Hormonal contraceptives may be less effective during concurrent telaprevir and for up to 2 weeks after telaprevir discontinuation. Consider therapy modification

Thalidomide: Contraceptives (Progestins) may enhance the thrombogenic effect of Thalidomide. Monitor therapy

Tipranavir: May increase the serum concentration of Contraceptives (Progestins). Management: Use an alternative or additional method of contraception due to possibly decreased contraceptive effectiveness. Injected depot medroxyprogesterone acetate does not appear to participate in this interaction. Consider therapy modification

Topiramate: May decrease the serum concentration of Contraceptives (Progestins). Management: Caution patients that this combination may be associated with reduced contraceptive effectiveness. Consider adding an additional (non-hormonal) contraceptive method. Consider therapy modification

Tranexamic Acid: Contraceptives (Progestins) may enhance the thrombogenic effect of Tranexamic Acid. Avoid combination

Ulipristal: May diminish the therapeutic effect of Progestins. Progestins may diminish the therapeutic effect of Ulipristal. Management: Ulipristal for uterine fibroids (Canadian indication): avoid progestins within 12 days of stopping ulipristal; as emergency contraceptive (U.S. indication): avoid progestins within 5 days of stopping ulipristal. Avoid combination

Vitamin K Antagonists (eg, warfarin): Contraceptives (Progestins) may diminish the anticoagulant effect of Vitamin K Antagonists. In contrast, enhanced anticoagulant effects have also been noted with some products. Management: When possible, concomitant hormonal contraceptives and coumarin derivatives should be avoided in order to eliminate the risk of thromboembolic disorders. Consider using an alternative, nonhormonal contraceptive. Consider therapy modification

Voriconazole: May increase the serum concentration of Contraceptives (Progestins). Contraceptives (Progestins) may increase the serum concentration of Voriconazole. Monitor therapy

Adverse Reactions

Frequency not always defined.

Cardiovascular: Edema (<5%), hypertension (<5%)

Central nervous system: Headache (≤12%), migraine (≤10%), depression (4% to 6%), mood changes (≤6%), nervousness (<5%), bipolar mood disorder (exacerbation), suicidal tendencies

Dermatologic: Acne vulgaris (6% to 15%), seborrhea (1% to 15%), alopecia (<5%), eczema (<5%), pruritus (<5%), skin rash (<5%), urticaria (<5%)

Endocrine & metabolic: Amenorrhea (≤38%, increases with duration of treatment), intermenstrual bleeding (23%), ovarian cyst (3% to 13%; includes symptomatic and asymptomatic cysts), hypermenorrhea (6% to 8%), decreased libido (<5%), hirsutism (<5%), weight gain (<5%), ectopic pregnancy

Gastrointestinal: Abdominal pain (≤23%), nausea (≤8%), vomiting (≤8%), abdominal distension (<5%)

Genitourinary: Abnormal uterine bleeding (52%), vulvovaginitis (≤20%), vaginal infection (14%), pelvic pain (≤23%), mastalgia (3% to 9%), dysmenorrhea (≤9%), breast tenderness (≤7%), dyspareunia (≤7%), vaginal discharge (4% to 5%), cervicitis (<5%; Papanicolaou smear normal/class II), endometritis (≤2%), uterine spasm (≤2%), genitourinary tract infection (upper, 1%), pelvic inflammatory disease

Hematologic & oncologic: Anemia (<5%)

Infection: Vulvovaginal infection (13%)

Neuromuscular & skeletal: Back pain (<5%)

Miscellaneous: Device expulsion (3% to 5%), ovarian follicle stimulation

<1% (Limited to important or life-threatening): Arterial thromboembolism, breakage of IUD, cerebrovascular accident, cervical perforation, hypersensitivity reaction, jaundice, malignant neoplasm of breast, myocardial infarction, sepsis (including Group A streptococcal sepsis), uterine hemorrhage, uterine perforation, venous thromboembolism

Warnings/Precautions

Concerns related to adverse effects:

• Bleeding irregularities: Menstrual bleeding patterns may be altered during the first 3 to 6 months with use of the intrauterine device (IUD); the possibility of pregnancy should be considered if menstruation does not occur within 6 weeks of the previous menstrual period. If bleeding irregularities continue with prolonged use, appropriate diagnostic measures should be taken to rule out endometrial pathology. An increase in menstrual bleeding may indicate a partial or complete expulsion of the IUD (see dosage form specific issues).

• Bradycardia/syncope: Bradycardia or syncope may occur during insertion or removal of the intrauterine device.

• Breast cancer: Breast cancer is a hormonal sensitive tumor. Use is contraindicated in women with (or history of) breast cancer.

• Ectopic pregnancy: Use caution in patients with previous ectopic pregnancy. Women with history of ectopic pregnancy were excluded from clinical trials; women 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 vaginal bleeding in women with prior amenorrhea. Ectopic pregnancy may result in loss of fertility.

• Ocular effects: IUD may need removed (temporarily or permanently) if ophthalmic problems or discomfort occur, including issues related to contact lenses.

• Ovarian cysts: May occur during IUD use; most are asymptomatic and disappear spontaneously within 2 to 3 months. Evaluate if persistent

Disease-related concerns:

• 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 intrauterine device (CDC 2010).

• Hepatic impairment: Use of the IUD is contraindicated with acute hepatic disease or hepatic tumors.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Obesity: Liletta: Body weight was not found to influence contraceptive efficacy in overweight, obese, or morbidly obese women.

• Pediatric: Not for use prior to menarche.

• Postmenopausal women: Not indicated for use in postmenopausal women.

• Smokers: The risk of cardiovascular side effects increases in women 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. Women who take contraceptives should be advised not to smoke. Smoking is not a contraindication to use of the intrauterine device (CDC 2010).

Dosage form specific issues:

• Intrauterine device (IUD):

- Infection: An increased incidence of group A streptococcal sepsis, pelvic inflammatory disease or endometritis (may be asymptomatic), and actinomycosis have been reported with use. Using aseptic technique during insertion is essential to minimizing the risk of serious infections. Pelvic inflammatory disease (PID) occurs more frequently within the first year and most often within the first month after insertion; risk is increased with multiple sexual partners. Women with a history of PID or endometritis are at increased risk. If PID is diagnosed, treat according to current guidelines and reassess in 24 to 48 hours. Remove IUD 24 to 48 hours after beginning antibiotics if there is no clinical improvement or if the woman wishes to discontinue use (CDC 2013). Women with symptomatic actinomycosis should have the device removed and be treated with the appropriate antibiotics.

- Perforation: Total or partial perforation may occur, most often during insertion, and may include penetration/embedment in the uterus or cervix; risk of perforation is increased in lactating women and when the uterus is fixed retroverted or not completely involuted during the postpartum period. Pregnancy may result if perforation occurs; delayed detection of perforation may result in migration of IUD outside of uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. Perforation may decrease effectiveness and lead to difficult removal.

- Expulsion: Partial or complete expulsion may occur. An increase in menstrual bleeding may indicate a partial or complete expulsion of the IUD. The risk of expulsion may be increased when the uterus is not completely involuted. If expulsion occurs, device may be replaced within 7 days of a menstrual period once pregnancy is ruled out.

- Magnetic resonance imaging (MRI): Only under specific conditions may Skyla or Jaydess [Canadian product] be scanned safely by MRI. Image quality may also be impaired if area of interest is relatively close to the device. Liletta is MRI safe.

- Consent form: Some products provide a consent form; a copy of the form and lot number should be kept with the woman’s medical record.

Special handling:

• Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH 2014 [group 2]).

Other warnings/precautions:

• Appropriate use: Intrauterine device: Insertion should be done by a trained health care provider. Insertion may be associated with pain bleeding, vasovagal reactions (eg, diaphoresis, syncope, bradycardia); especially in patient’s predisposed to these conditions, or seizure in an epileptic patients. Removal of the device may be necessary for the following reasons: pelvic infection, symptomatic genital actinomycosis, endometrial or cervical cancer, uterine or cervical perforation, and pregnancy. Use the intrauterine system 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 uterine or cervical malignancy or jaundice occurs during use. Not effective for emergency contraception.

• HIV infection protection: Hormonal contraceptives do not protect against HIV infection or other sexually-transmitted diseases (CDC 2013).

• Laboratory changes: The use of estrogens and/or progestins may change the results of some laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). The dose, route, and the specific estrogen/progestin influences these changes. In addition, personal risk factors (eg, cardiovascular disease, smoking, diabetes, age) also contribute to adverse events; use of specific products may be contraindicated in women with certain risk factors.

Monitoring Parameters

Prior to insertion: Assessment of pregnancy status; cervical examination; 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, 2013). 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, 2013). Re-examine following insertion (4 to 6 weeks 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 women who require surgery with prolonged immobilization.

Pregnancy Considerations

Use during pregnancy is contraindicated. Pregnancy should be ruled out prior to insertion. Women who become pregnant with an IUD in place risk septic abortion; septicemia, septic shock and death may occur. Hysterectomy may be required in cases of severe infection. Removal of the device is recommended, however, removal or manipulation of IUD may result in pregnancy loss. In addition, miscarriage, sepsis, premature labor, and premature delivery may occur if pregnancy is continued with IUD in place. Following pregnancy, the manufacturer recommends that insertion of the device should not take place until at least 6 weeks postpartum or until involution of the uterus is complete. The device may be inserted immediately following a first trimester abortion. Following removal of the device, ~77% to 87% of women who wished to conceive became pregnant within 12 months.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience acne, vomiting, or nausea. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), angina, dizziness, abdominal pain, pelvic pain, abnormal vaginal bleeding, vaginitis, chills, lump in breast, breast soreness or pain, device complication, painful intercourse, severe headache, bruising, bleeding, jaundice, mood changes, depression, or genital sores (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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