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FAQs about Kyleena

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  • Expiration date is etched on the carton and printed on the label. Insert Kyleena before the end of the month shown.

Risk of Ectopic Pregnancy

  • 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 Pregnancy

  • 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. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.

  • 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 conditions:

    • 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 scanning.

  • 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 system.

  • MR=magnetic resonance; IUS=intrauterine system

  • Once you have determined that Kyleena is an appropriate option for your patient, Kyleena can be inserted at any time that you can be reasonably certain that your patient is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product.

  • If Kyleena is inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion, back up contraception is not needed.

  • If Kyleena is not inserted during the first seven days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for seven days to prevent pregnancy.

  • For more information, please visit Insertion & Removal instructions.

  • The removal threads are contained within the insertion tube and handle. Once Kyleena has been placed, the inserter is discarded.

  • By pushing the slider on the Inserter forward, Kyleena loads into its proper position inside in the insertion tube. Do not move the slider downward at this time, as this may prematurely release the threads of Kyleena. Once the slider is moved below the mark, Kyleena cannot be reloaded. For more information on the Kyleena inserter, including full insertion instructions and an instructional video, please visit Insertion & Removal.

  • Kyleena can alter the bleeding pattern and result in spotting, irregular bleeding, heavy bleeding, oligomenorrhea, and amenorrhea. During the first 3-6 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 irregular.

  • 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 complaints. Please see Bleeding Data for more information.

  • Because irregular bleeding/spotting is common during the first months of Kyleena use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Kyleena in women with persistent or uncharacteristic bleeding. 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 six 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 pain.

  • No, Kyleena is only indicated to prevent pregnancy for up to 5 years.

  • Clinical trials with Kyleena excluded breast-feeding women. A large postmarketing safety study conducted in Europe over a 1-year observational period reported that lactation at the time of insertion of an IUD/IUS was associated with an increased risk of perforation. For users of another LNG-releasing IUS, the incidence of uterine perforation was reported as 6.3 per 1,000 insertions for lactating women, compared to 1.0 per 1,000 insertions for non-lactating women.

  • Tell your patients that she can breastfeed if more than 6 weeks have passed since delivery. 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 among women using progestin. The risk of Kyleena becoming attached to (embedded) or going through the wall of the uterus is increased if Kyleena is inserted while she is breastfeeding.

  • Risk Summary

  • 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 another 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.

  • LNG=levonorgestrel; IUS=intrauterine system; IUDs=intrauterine devices

  • Kyleena has been studied in both parous and nulliparous women.

MRI=magnetic resonance imaging