KYLEENA® FAQs
What was the demonstrated contraceptive efficacy (Pearl Index and Kaplan-Meier failure rate) of KYLEENA®?*
The Pearl Index at 1 year was 0.16 and at 5 years it was 0.29. KYLEENA® provided more than 99% efficacy for each year of use; contraceptive failure rate with KYLEENA® was <0.5% for each year of use. A high level of efficacy was shown over 5 years in the pivotal trial.2,3*
| Time point | Number of women | Number of pregnancies | Kaplan-Meier failure rate (%) | Failure rate 95 % CI | Contraceptive efficacy (%) |
|---|---|---|---|---|---|
| Year 1 | 1,452 | 2 | 0.178 | 0.044–0.709 | 99.8% |
| Year 2 | 1,206 | 4 | 0.371 | 0.139–0.988 | 99.6% |
| Year 3 | 1,010 | 4 | 0.423 | 0.159–1.123 | 99.6% |
| Year 4 | 773 | 1 | 0.147 | 0.021–1.038 | 99.8% |
| Year 5 | 636 | 2 | 0.333 | 0.083–1.324 | 99.7% |
| 5 years (Cumulative) | 1,452 | 13 | 1.445 | 0.823–2.531 | 98.5% |
Adapted from KYLEENA® Product Monograph.2
What is the hormone in KYLEENA® and its release rate?
The progestin levonorgestrel (LNG) is the only hormone in KYLEENA®. Estimated average in vivo release rate of LNG over 5 years was 9.0 mcg/24 hours.2†
Based on its pharmacodynamic profile, with the use of KYLEENA®, what are the trends in bleeding patterns?†
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. In most women, there is a trend over time towards less frequent and shorter episodes of bleeding.2†
The duration and volume of menstrual bleeding increases initially; with continued use, bleeding patterns vary from regular menstruation in some women, to irregular or prolonged bleeding in other women, and amenorrhea in others.‡
Because irregular bleeding is common during the first months of therapy with all IUSs, including KYLEENA®, it is recommended to exclude endometrial pathology before insertion of KYLEENA®. Irregular bleeding patterns in users of KYLEENA® could mask the signs and symptoms of cervical or endometrial cancer. If bleeding irregularities develop after prolonged use, appropriate diagnostic measures should be undertaken.
It is also important to counsel women about how their bleeding pattern may change after insertion of KYLEENA®. The instructions for insertion should be followed carefully. The patient should be re-examined 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
What is the mechanism of action of KYLEENA®?†
KYLEENA® is a long-acting reversible contraceptive (LARC). After insertion in the uterus, LNG is immediately released from the IUS into the uterine cavity. More than 90% of the released levonorgestrel is systemically available. KYLEENA® releases LNG continuously for up to 5 years. Intrauterine administration allows a very low daily dosage of progestin (average over 5 years of 9.0 mcg per 24 hours), as the hormone is released directly to the target organ.2†
KYLEENA® has mainly local progestogenic effects in the uterine cavity.2†
In the phase III pivotal trial, how did the investigators rate the insertion procedure?
In an open-label, phase III pivotal trial the insertion procedure was evaluated by the study investigators as easy:2*
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89.7% of all women
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84.3% of nulliparous women
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93.2% of parous women
The study included 1452 women aged 18–35 including 39.5% (574) nulliparous women.2*
What is the size of the KYLEENA® T-body and the diameter of the insertion tube?
KYLEENA® has a small T-body (size 28 X 30 mm). The narrow insertion tube has an outer diameter of 3.8 mm.2,4†
What data supports KYLEENA®’s reversibility?†
The use of KYLEENA® does not alter the course of future fertility; upon removal of KYLEENA®, women return to their normal fertility. In a 5-year study, 71.2% (116/163) of women who discontinued because of the wish for pregnancy, and with follow-up information available, became pregnant during the 12-month follow-up.2†
What was the incidence of expulsion?
According to the KYLEENA® Product Monograph, in clinical trials with KYLEENA®, the incidence of expulsion was 3.5% (59 of 1,690 subjects over 5 years) and in the same range as that reported for other IUDs and IUSs.
In a large, retrospective, cohort study (mean observation time of 2 years) in LNG IUS and copper IUD users (N=326,658 women), the overall incidence of expulsion was 2.74 per 100 IUS/IUD insertions.
The risk of expulsion may be increased when the uterus is not completely involuted at the time of insertion.2
Symptoms of the partial or complete expulsion of KYLEENA® may include bleeding or pain. However, partial or complete expulsion can occur without the woman noticing it, resulting in the loss of efficacy. As KYLEENA® typically decreases menstrual bleeding over time, an increase of menstrual bleeding may be indicative of an expulsion. A partially expelled KYLEENA® should be removed. A new system can be inserted at that time provided pregnancy has been excluded.2
What was the rate of perforation?
According to the KYLEENA® Product Monograph, during initial clinical trials, perforation occurred rarely, at a rate between 0.1 and 1 per 1,000 insertions. Breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation. The risk of perforation may be increased in women with abnormal uterine anatomy or with fixed retroverted uterus.
These clinical trials with KYLEENA® excluded breastfeeding women.§ Delayed detection of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforation and obstruction, abscesses and erosion of adjacent viscera. The number of uterine perforations is linked to the experience of the person inserting the system.
When should KYLEENA® be inserted?
In women of fertile age, KYLEENA® should be inserted within 7 days of the onset of menstruation. When inserted within 7 days of the onset of menstruation, no backup contraception is needed. For more information on insertion, please see Insertion, Removal and Replacement in the Dosing and Administration section of the product monograph. KYLEENA® can be inserted any time during the cycle if the healthcare professional can be reasonably certain (as defined by the World Health Organization) that the woman is not pregnant.
Results from a multi-centre international, open-label, randomized clinical study for 3 years with an extension to 5 years in 1,452 women aged 18–35 evaluating the contraceptive efficacy of KYLEENA® (levonorgestrel-releasing intrauterine system [19.5 mg]).
Clinical significance has not been established.
Menstrual bleeding patterns were recorded by all women throughout their participation in clinical trials with KYLEENA®, starting from the day of insertion. Menstrual bleeding patterns were assessed using the WHO 90-day reference period method. Data reported for each reference period reflect the number of women actually enrolled in trials during that specific reference period and for whom valid bleeding diaries were returned.2,5
In a separate study, incidence of perforation was assessed in both breastfeeding and non-breastfeeding women. Incidences of perforation/1,000 insertions over 1 year were as follows: with insertion ≤36 weeks after delivery, 5.6 (95% CI 3.9–7.9; n=6,047 insertions) in breastfeeding women and 1.7 (95% CI 0.8–3.1; n=5,927 insertions) in non-breastfeeding women. When insertion was after 36 weeks, the corresponding rates were 1.6 (95% CI 0.0–9.1; n=608 insertions) and 0.7 (95% CI 0.5–1.1; n=41,910-insertions), respectively.
