Kyleena is a hormone-releasing intrauterine device that prevents unwanted pregnancy for up to 5 years. The system contains 1 female hormone – levonorgestrel.
Indications for use
The active component of Kyleena, levonorgestrel, has not only a contraceptive but also a therapeutic effect. Therefore, it is suitable for those women, whose unwillingness to become pregnant is combined with some gynecological problems. Since the device is thinning the endometrial layer, it can be used for endometrial hyperplasia.
This IUD is also an excellent preventive tool for endometriosis. There are unconfirmed reports that with endometriosis, this levonorgestrel-releasing system it can be not only a preventative but also a therapeutic agent. Another effect of the drug is a decrease in the volume of blood loss and a reduction in pain during menstruation. Therefore, it is used in cases of heavy menstruation accompanied by anemia, as well as with algodismenorrhea.
Besides, Kyleena is an excellent method of contraception for women in the pre-climacteric period.
Mechanism of action
Kyleena is a hormonal spiral made of a synthetic material, which takes a T-shaped configuration when introduced into the uterus.
The vertical element of the letter T is a core with a hormonal-elastomeric content of an off-white color. This content is levonorgestrel, a synthetic progestin, an analog of the natural hormone progesterone. In total, the core contains 19.5 mg of levonorgestrel.
The core is covered with a translucent membrane. Thanks to this membrane, the system releases 17.5 mcg of levonorgestrel per day into the uterine cavity. This amount is too small to cause systemic side effects in the form of various metabolic disorders. But it can provide reliable contraception. After all, levonorgestrel has a complex contraceptive effect:
- causes thickening of cervical mucus and makes difficult for sperm to enter the uterine cavity through the cervical canal;
- deprives spermatozoa of the mobility.
- slows down the peristalsis (wave-like contractions) of the fallopian tubes. For this reason, a fertilized egg is more difficult to enter the uterine cavity.
- slows down the proliferation (growth of cells) of the uterine endometrium, reduces the functional activity of its glands. It is difficult for a fertilized egg to attach to such a thin endometrium;
- slows down follicle maturation and ovulation. This effect of Kyleena IUD is auxiliary and weakly expressed.
Mode of application
Kyleena is inserted into the uterine cavity and remains effective for five years. The initial release rate of levonorgestrel in vivo is approximately 17.5 mcg per day and decreases after five years to approximately 8.5 mcg per day. The intrauterine device can be used in women receiving hormone replacement therapy in combination with oral or trenodermal estrogen preparations that do not contain gestagens. If the device was correctly installed in accordance with the instructions for use, the Perle index is approximately 0.1% per year. In the case of expulsion or perforation, the Pearl index may increase.
Insertion of Kyleena is allowed only by a gynecologist in a specialized medical institution. Another condition: the device should be stored in a sterile vacuum package. If the integrity of this package is violated, the product is considered unusable and cannot be used.
The preferred installation time is the first 7 days after menstruation. Women who have ever born children are allowed to install the IUD not earlier than 6 weeks after delivery.
After medical and spontaneous abortions, the device is inserted no earlier than 7 days after delivery. Prior to insertion, the IUD is stored in the folded state in a plastic conductor having the shape of a tube. The conductor with a spiral is inserted into the cervical canal. In this case, the vertical support arms of the system in the uterine cavity are straightened, and Kyleena takes the T-shape.
After the introduction of the helix, the conductor is discarded, the existing filamentous tendrils are cut off. With the correct administration, the procedure is painless and does not require anesthesia.
The contraceptive effect develops immediately after insertion of the device.
During the first months, levonorgestrel-releasing intrauterine devices can cause the following side effects:
- headache, dizziness;
- emotional instability;
- nausea, decreased appetite;
- pain in the lower abdomen;
- back pain;
- weight gain;
- an increase of sensitivity of mammary glands.
As a rule, all these symptoms are temporary and do not require special treatment. Some patients may experience a complete absence of menstruation (amenorrhea), which can be mistaken for pregnancy.
If you have any disturbing symptoms, you should consult a doctor who has inserted the IUD.
Hormonal intrauterine devices are not suitable for every woman. It does not protect against genitourinary infections. Moreover, the device can promote the vaginal infection deep into the cervix and into the uterine cavity. Therefore, any acute infectious inflammatory diseases of the vagina, cervix, lower parts of the urinary tract, pelvic organs will be contraindications to the use of Kyleena. After successful treatment of these diseases, the insertion of the IUD is allowed but not earlier than 3 months after it.
- long-lasting chronic inflammatory gynecological diseases that are difficult to treat;
- dysplasia of the cervix;
- uterine fibroids;
- malignant tumors of the gynecological sphere;
- breast cancer;
- congenital anomalies of the uterine structure;
- HIV, acute viral and chronic hepatitis, cirrhosis of the liver.
Some somatic non-gynecological diseases are relative contraindications to the use of Kyleena:
- hypertonic disease;
- heart attacks and strokes in the past;
- thrombophlebitis of lower extremities;
With these diseases, the question of the IUD’s safety is decided individually. Therefore, before inserting the hormonal system, the woman goes through all the necessary research with expert advice.
The method of introducing levonorgestrel via the intrauterine device into the body does not imply the possibility of an overdose.
When combined with estrogen-containing drugs (most often in women in the pre-menopausal and menopausal period), the patients using hormone-releasing intrauterine devices gradually lose their periods.
Some anticonvulsants (phenobarbital), as well as a number of antibiotics (rifampicin, etc.) accelerate the processing of levonorgestrel by the body, although the loss of contraceptive effect of Kyleena has not been recorded anywhere.
Levonorgestrel is absorbed into the blood in insignificant quantities, therefore it enters the breast milk in insignificant quantity. For this reason, Kyleena can be used for birth control in lactating women who are not allowed to take oral hormonal preparations because of the possible negative effects on the child.
Prior to the insertion of the IUD, pathological processes in the endometrium should be excluded since irregular bleeding / spotting are often observed in the first months of use. Also, it is necessary to exclude pathological processes in the endometrium in the event of bleeding after the initiation of estrogen replacement therapy in a woman who continues to use Kyleena, previously prescribed for contraception. Appropriate diagnostic measures must also be taken when irregular bleeding develops during prolonged treatment.
Hormone-releasing intrauterine devices are not used for postcoital contraception.
The preparation should be used with caution in women with congenital or acquired valvular heart disease (the risk of septic endocarditis). When inserting or removing the IUD, these patients should be prescribed antibiotics for the purpose of prevention.
Levonorgestrel in low doses can affect glucose tolerance, and therefore its concentration in the blood plasma should be regularly monitored in women with diabetes who are using intrauterine devices. As a rule, correction of the dose of hypoglycemic drugs is not required.
Some manifestations of polyposis or endometrial cancer can be masked by irregular bleeding. In such cases, an additional examination is needed to clarify the diagnosis.
Kyleena does not belong to first-line drugs for young women who have never been pregnant. Women in the postmenopausal period with severe atrophy of the uterus are also not recommended to use this preparation.
The available data indicate that the use of the IUD does not increase the risk of developing breast cancer in postmenopausal women under the age of 50 years.
Oligomenorrhea and amenorrhea:
Oligomenorrhoea and amenorrhea in women of childbearing age develop gradually, approximately in 57% and 16% of cases by the end of the first year of using the IUD, respectively. If periods are absent within 6 weeks, pregnancy should be excluded. Repeated pregnancy tests for amenorrhea are not required unless there are other signs of pregnancy.
When Kyleena is used in combination with a permanent estrogen replacement therapy, most women develop amenorrhea gradually during the first year.
Inflammatory diseases of the pelvic organs:
The tube-conductor helps to protect the system from infection during the insertion, and the device is specially designed to minimize the risk of infection. Inflammatory diseases of the pelvic organs in patients using the IUD are often referred to as sexually transmitted diseases. The presence of multiple sexual partners is a risk factor for pelvic infections.
Inflammatory diseases of the pelvic organs can have serious consequences: they are capable of disrupting the childbearing function and increasing the risk of ectopic pregnancy.
Severe infection or sepsis (including group A streptococcal sepsis) can develop after the IUD insertion, although such cases are extremely rare.
With relapsing endometritis or inflammatory diseases of the pelvic organs, as well as with severe or acute infections resistant to treatment for several days, Kyleena should be removed. If you have constant pain in the lower abdomen, chills, fever, pain associated with sexual intercourse (dyspareunia), prolonged or profuse bleeding from the vagina, changing the nature of vaginal discharge, you should immediately consult a doctor. Severe pain or fever, which occurs soon after the IUD insertion, may indicate a severe infection that must be treated immediately.
Possible signs of a partial or complete expulsion of any IUD are bleeding and pain. Contractions of the uterus during menstruation sometimes causes a displacement of the system or expulsion from the uterus, which stops the contraceptive effect. Partial expulsion may decrease the effectiveness of the drug. Since the intrauterine device reduces menstrual blood loss, its increase may indicate an expulsion of the IUD. A woman is recommended to check the threads with her fingers, for example, during showering. If a woman has detected signs of displacement or prolapse of the IUD, sexual intercourse or other methods of contraception should be avoided, and a doctor should be consulted as soon as possible.
If the position is incorrect, the IUD should be removed. At the same time, a new system can be inserted. A doctor should explain to a woman how to check the threads of Kyleena.
Perforation and penetration:
Perforation or penetration of the body or cervix of the IUD occurs rarely, mainly during the insertion, and may decrease the effectiveness of the hormonal system. In these cases, the device should be removed. If the diagnosis of perforation and migration of the IUD is delayed, a woman can experience complications such as adhesions, peritonitis, intestinal obstruction, intestinal perforation, abscesses or erosion of adjacent internal organs. The risk of uterine perforation is elevated in breastfeeding women. The risk of perforation during IUD insertion is increased in women with fixed uterine bend and in women who have given a birth to a child.
Women with an ectopic pregnancy in the anamnesis are at higher risk of ectopic pregnancy. This group also includes those who have undergone operations on the fallopian tubes or had an infection of the pelvic organs. The possibility of an ectopic pregnancy should be considered in case of abdominal pain, especially if it is combined with the cessation of menstruation, or when a woman with amenorrhea starts bleeding. The frequency of ectopic pregnancy with Kyleena is approximately 0.1% per year. The absolute risk of ectopic pregnancy in women using hormone-releasing intrauterine devices is low. However, if a woman with an inserted Kyleena drug becomes pregnant, the relative probability of an ectopic pregnancy is higher.
Loss of threads:
If gynecological examination of the thread for removal of the IUD cannot be detected in the cervical region, pregnancy should be excluded. Threads can be drawn into the uterine cavity or the cervical canal and become visible again after another menstrual period. If pregnancy is excluded, the location of the strands can usually be determined by careful probing with the appropriate instrument. If it is not possible to detect the threads, it is possible that the IUD has expelled from the uterine cavity. To determine the correct location of the system, you can conduct an ultrasound. If it is unavailable or unsuccessful, an X-ray examination is performed to determine the location of Kyleena.
Since the contraceptive effect of the hormone-releasing intrauterine device is due mainly to its local action, women of fertile age usually observe ovulatory cycles with follicle rupture. Sometimes atresia of the follicles is delayed, and their development can continue. Such enlarged follicles are clinically impossible to distinguish from ovarian cysts. About ovarian cysts as an adverse reaction was reported in approximately 7% of women who used the intrauterine device. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during sexual intercourse. As a rule, the ovarian cysts disappear on their own for two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound and resort to medical and diagnostic measures. In rare cases, it is necessary to undergo surgical intervention.
The ancillary substances contained in Kyleena include barium sulfate, which becomes visible during X-ray examination.
Levonorgestrel-releasing system does not protect against HIV infection and other sexually transmitted diseases.
Impact on the ability to drive vehicles and control mechanisms: