Frequently Asked Questions (FAQs) About Kyleena^®

If you have a question that is not covered here, please contact us directly. If your patients have questions, direct them to the Kyleena Patient FAQs page.

Go to questions regarding:

Kyleena indication and usage
Size of Kyleena and insertion
Kyleena safety considerations
Kyleena costs and insurance coverage

Kyleena indication and usage

How long is Kyleena effective for?

Kyleena is indicated to prevent pregnancy for up to 5 years. The system should be replaced after 5 years if continued use is desired. Remember to check the expiration date of Kyleena prior to initiating insertion. The expiration date is etched on the carton and printed on the label. Insert Kyleena before the end of the month shown¹

Can Kyleena be used in nulliparous patients?

Yes. Kyleena has been studied in both parous and nulliparous women. Use of Kyleena before menarche is not indicated¹

Are there body mass index (BMI) parameters necessary to follow for Kyleena to be effective?

The clinical trials had no upper or lower weight or BMI limit. The weight range was 38 to 173 kg (mean weight: 68.7 kg) and mean BMI was 25.3 kg/m² (range 15.2–57.6 kg/m²)¹

What is the hormone release rate of Kyleena?

The Kyleena steroid reservoir contains a total of 19.5 mg LNG, and is intended to provide an initial release rate of approximately 17.5 mcg/day of LNG after 24 days. This rate decreases progressively to 9.8 mcg/day after 1 year and to 7.4 mcg/day after 5 years. The average in vivo release rate of LNG is approximately 12.6 mcg/day over the first year and 9.0 mcg/day over a period of 5 years¹

LNG=levonorgestrel.

Do I need to provide backup contraception when Kyleena is first inserted?

Depending on the patient’s prior method of contraception and when during the menstrual cycle Kyleena is being inserted, backup contraception may be appropriate¹
If Kyleena is inserted during the first 7 days of the menstrual cycle or immediately after a first trimester abortion, backup contraception is not needed. If Kyleena is not inserted during the first 7 days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy¹

Please see the full Prescribing Information for when backup contraception may be recommended.

Click here for more information on insertion and removal instructions.

Does Kyleena also help treat heavy menstrual bleeding (HMB)?

No, Kyleena is only indicated to prevent pregnancy for up to 5 years¹

Size of Kyleena and insertion

What is the size of the Kyleena T-body?

The Kyleena IUD is 30 mm long by 28 mm wide¹

Click here for more information about the size of Kyleena and inserter.

Can Kyleena be reloaded during insertion?

Once released, Kyleena cannot be reloaded. Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Kyleena from the inserter¹

Click here for more information about the Kyleena insertion process.

Can Kyleena be inserted on the same day as an in-office visit?

Depending on a patient's status, same day insertion could be appropriate if the provider can be reasonably certain the woman is not pregnant. Please see the full Prescribing Information for more details.

Kyleena safety considerations

What pregnancy risks are associated with Kyleena?

Risk of ectopic pregnancy¹
Evaluate women for ectopic pregnancy if they become pregnant with Kyleena in place because the likelihood of a pregnancy being ectopic is increased with Kyleena. Approximately one-half of pregnancies that occur with Kyleena in place are likely to be ectopic. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding

The incidence of ectopic pregnancy in clinical trials with Kyleena, which excluded women with a history of ectopic pregnancy, was approximately 0.2% per year. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Kyleena is unknown. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. Ectopic pregnancy may result in loss of fertility
Risks with intrauterine pregnancy¹
If pregnancy occurs while using Kyleena, remove Kyleena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Kyleena or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Kyleena, consider the following:

Septic abortion

In patients becoming pregnant with an IUS in place, septic abortion—with septicemia, septic shock, and death—may occur.

Continuation of pregnancy

If a woman becomes pregnant with Kyleena in place and if Kyleena cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Kyleena increases the risk of miscarriage, sepsis, premature labor and premature delivery. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.

IUS=intrauterine system.

Can patients with Kyleena safely receive an MRI?

Non-clinical testing has demonstrated that Kyleena is MR Conditional. A patient with Kyleena can be safely scanned in an MR system meeting the following conditions¹:
- Static magnetic field of 3.0 T or less
- Maximum spatial field gradient of 36,000 gauss/cm (360 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled Operating Mode)
Under the scan conditions defined above, the Kyleena IUS is expected to produce a maximum temperature rise of less than 2ºC after 15 minutes of continuous scanning¹
In non-clinical testing, the image artifact caused by the IUS extended up to 5 mm from the IUS when imaged with a gradient echo pulse sequence and a 3.0 T MRI system¹

IUS=intrauterine system; MR=magnetic resonance; MRI=magnetic resonance imaging.

Can women breastfeed during use of Kyleena?

Tell your patients that they may use Kyleena when they are breastfeeding. Kyleena is not likely to affect the quality or amount of breast milk or the health of the nursing baby. However, isolated cases of decreased milk production have been reported. The risk of Kyleena going into the wall of the uterus (becoming embedded) or going through the wall of the uterus is increased if Kyleena is inserted while breastfeeding
Published studies report the presence of LNG in human milk. Small amounts of progestins (approximately 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. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Kyleena and any potential adverse effects on the breastfed child from Kyleena or from the underlying maternal condition
APEX IUD was a large US retrospective cohort study to assess the impact of breastfeeding and timing of postpartum IUD insertion on uterine perforation and IUD expulsion. Breastfeeding data were available in 94,817 insertions performed in women 52 weeks or less after delivery. Women who were breastfeeding at the time of insertion were at 33% higher risk of perforation (adjusted hazard ratio [HR]=1.33, 95% confidence interval [CI]: 1.07–1.64) compared to women who were not breastfeeding at the time of insertion. Progressively lower risk of uterine perforation was observed in postpartum time windows beyond 6 weeks, in both breastfeeding and not breastfeeding women. Women who were breastfeeding were at 28% lower risk of IUD expulsion (adjusted HR=0.72, 95% CI: 0.64-0.80) compared to women who were not breastfeeding at time of insertion. For more information, please see section 6.2 Postmarketing Experience of the full Prescribing Information

IUD=intrauterine device; IUS=intrauterine system; LNG=levonorgestrel.

What bleeding changes are to be expected in patients using Kyleena?

Kyleena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea, and amenorrhea. During the first 3 to 6 months of Kyleena use, the number of bleeding and spotting days may be higher and bleeding patterns may be irregular. Thereafter, the number of bleeding and spotting days usually decreases but bleeding may remain irregular¹
In Kyleena clinical trials, amenorrhea developed by the end of the first year of use in approximately 12% of Kyleena users. A total of 81 subjects out of 1697 (4.8%) discontinued due to uterine bleeding complaints¹
If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology. Consider the possibility of pregnancy if menstruation does not occur within 6 weeks of the onset of a 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 pain¹

Click here for more information on bleeding data for Kyleena.

What is the expulsion rate for Kyleena?

In clinical trials, a 5-year expulsion rate of 3.5% (59 out of 1690 subjects) was reported¹
Partial or complete expulsion of Kyleena may occur, resulting in the loss of contraceptive protection. Expulsion may be associated with symptoms of bleeding or pain, or it may be asymptomatic and go unnoticed. Kyleena typically decreases menstrual bleeding over time; therefore, 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
The 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 the US, the risk of expulsion was lower with breastfeeding status¹
Remove a partially expelled Kyleena. If expulsion has occurred, a new Kyleena can be inserted any time the provider can be reasonably certain the woman is not pregnant¹

Kyleena cost and coverage

How much does Kyleena cost?

The wholesale acquisition cost of Kyleena before discounts is $1,156.79²
Bayer offers discount programs for providers and support programs for patients

Click here for more information on Bayer IUD support programs.

Is there a co-pay card for Kyleena?

Kyleena offers a co-pay card savings program for your patients. Eligible commercially insured patients may pay as little as $20 for the Kyleena IUD.* Other costs may still be incurred by the patient
95% of patients had coverage for a Bayer IUD with low or no out-of-pocket costs based on benefit investigation submissions to Bayer in 2017 (other products costs may apply; N=291,664)²

*Eligible patients may pay as little as $20 for the cost of the Kyleena IUD. Benefit limitations apply. For full terms and conditions please reference copayforkyleena.com. Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payers of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in the Bayer US Patient Assistance Foundation are not eligible. Bayer may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the Co-pay Savings Program for Kyleena at any time, including but not limited to this commercial co-pay assistance program.

Click here for more information on Kyleena co-pay card savings program.

IUD=intrauterine device.

Is there a patient assistance program for Kyleena?

Yes, the Bayer US Patient Assistance Foundation is a charitable organization that helps eligible patients get their Bayer prescription medicine at no cost. Please have your patient contact the program at 1-866-2BUSPAF (228-7723), Monday to Friday, 9 AM to 6 PM EST, or visit the foundation website https://www.patientassistance.bayer.us/

Is Kyleena covered by Medicaid?

State Medicaid programs offer coverage for contraceptives. However, state Medicaid program eligibility guidelines may vary and could restrict access to Kyleena for some women. As with private payers, offices should verify coverage prior to treatment. Among women enrolled in Medicaid managed care organizations (Medicaid MCOs), coverage will be based on the specific Medicaid MCOs’ policies for Kyleena

Request a Rep

Stay up to date with clinical information and virtual trainings for Kyleena.

Cost and Coverage Information

Review helpful information for ordering Kyleena.

Important Safety Information

View Important Safety Information for Kyleena.

Expand Collapse

INDICATION FOR KYLEENA^®

Kyleena 19.5 mg is indicated for the prevention of pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired.

IMPORTANT SAFETY INFORMATION

Who is not appropriate for Kyleena: Use of Kyleena is contraindicated in women with: known or suspected pregnancy and cannot be used for post-coital contraception; congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity; known or suspected breast cancer or other progestin-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; liver disease, including tumors; untreated acute cervicitis or vaginitis, including lower genital tract infections (e.g., bacterial vaginosis) until infection is controlled; postpartum endometritis or infected abortion in the past 3 months; unexplained uterine bleeding; current IUD; acute pelvic inflammatory disease (PID) or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of Kyleena.

Clinical considerations for use and removal of Kyleena

Use Kyleena with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; exceptionally severe headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing the intrauterine system if these or the following arise during use: uterine or cervical malignancy or jaundice. If the threads are not visible or are significantly shortened they may have broken or retracted into the cervical canal or uterus. If Kyleena is displaced (e.g., expelled or perforated the uterus), remove it. Kyleena can be safely scanned with MRI only under specific conditions.

Pregnancy related risks with Kyleena

If pregnancy should occur with Kyleena in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with Kyleena. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

Educate her about PID

Kyleena is contraindicated in the presence of known or suspected PID or in women with a history of PID unless there has been a subsequent intrauterine pregnancy. IUDs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Promptly examine users with complaints of lower abdominal pain or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores. Inform women about the possibility of PID and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death. PID is often associated with sexually transmitted infections (STIs). Kyleena does not protect against STIs, including HIV. PID may be asymptomatic but still result in tubal damage and its sequelae.

In clinical trials with Kyleena PID occurred more frequently within the first year and most often within the first month after insertion.

Expect changes in bleeding patterns with Kyleena

Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation.

If a significant change in bleeding develops during prolonged use, take appropriate diagnostic measures to rule out endometrial pathology.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUDs like Kyleena are sepsis, perforation and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of a LNG-releasing IUS. Aseptic technique during insertion of Kyleena is essential in order to minimize serious infections, such as GAS.

Perforation (total or partial, including penetration/embedment of Kyleena in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. The risk of uterine perforation is increased in women who have recently given birth, and in women who are breastfeeding at the time of insertion. In a large US retrospective, postmarketing safety study of IUDs, the risk of uterine perforation was highest when insertion occurred within ≤6 weeks postpartum, and also higher with breastfeeding at the time of insertion. The risk of perforation may be increased if inserted when the uterus is fixed, retroverted or not completely involuted. If perforation occurs, locate and remove Kyleena. Surgery may be required. Delayed detection or removal of Kyleena in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. In addition, perforation may reduce contraceptive efficacy and result in pregnancy.

Partial or complete expulsion of Kyleena may occur resulting in the loss of contraceptive protection. The 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 the same postmarketing study, the risk of expulsion was lower with breastfeeding status. Remove a partially expelled IUD. If expulsion has occurred, a new Kyleena can be inserted any time the provider can be reasonably certain the woman is not pregnant.

Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic pain or dyspareunia. Evaluate persistent enlarged ovarian cysts.

In clinical trials with Kyleena the most common adverse reactions (≥5%) were vulvovaginitis (24%), ovarian cyst (22%), abdominal/pelvic pain (21%), headache/migraine (15%), acne/seborrhea (15%), dysmenorrhea/uterine spasm (10%), breast pain/breast discomfort (10%), and increased bleeding (8%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of Kyleena and then yearly or more often if clinically indicated.

For important information about Kyleena, please see the Full Prescribing Information.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

BAYER, the Bayer Cross, Kyleena, Mirena, and Skyla are registered trademarks of Bayer.

Site Last Modified: 06/2024

Frequently Asked Questions (FAQs) About Kyleena®