Kyleena

/ Bayer

Placement of Kyleena: Placement of Kyleena will be done by a physician who has undergone training on the insertion procedure and after a gynaecological examination.
Kyleena can either be placed:
• within 7 days from the start of your menstrual bleed (your monthly period).
• immediately after a first trimester abortion provided that there are no genital infections.
• after giving birth only after the womb has returned to its normal size, and not earlier than 6 weeks after delivery.
Examination by the doctor before placement may include:
• a cervical smear test (Pap smear).
• examination of the breasts.
• other tests, e.g. for infections, including sexually transmitted diseases, as necessary. The doctor will also do a gynaecological examination to determine the position and size of the womb.
After a gynaecological examination:
• an instrument called a speculum is placed into the vagina, and the cervix may be cleansed with an antiseptic solution.
Kyleena is then placed into the womb using a thin, flexible plastic tube (the placement tube). Local anaesthesia may be applied to the cervix prior to placement.
• some women feel dizzy or faint during placement or after Kyleena is placed or removed.
• patient may experience some pain and bleeding during or just after placement.

Follow-up examination: You should have your Kyleena checked 4-6 weeks after placement, and thereafter regularly, at least once a year.
Your doctor may determine how often and what kinds of check-ups are required in your particular case. If you received a patient reminder card from your doctor bring this with you to every scheduled appointment.
Removal of Kyleena: Kyleena should be removed no later than the end of the
fifth year of use.
Kyleena can be easily removed at any time by your doctor, after which pregnancy is possible. Some women feel dizzy or faint during or after Kyleena is removed. You may experience some pain and bleeding during removal of Kyleena.
If pregnancy is not desired, Kyleena should not be removed after the seventh day of the menstrual cycle (monthly period) unless you use other methods of contraception (e.g. condoms) for at least 7 days before the IUS removal.
If you have irregular periods (menses) or no periods, you should use a barrier method of contraception for 7 days before removal.
A new Kyleena can also be placed immediately after removal, in which case no additional protection is needed.
If you have further questions regarding use of the medicine, consult the doctor or pharmacist.

Contraception for up to 5 years.

• Pregnancy;
• Acute or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections;
• Acute cervicitis or vaginitis;
• Postpartum endometritis or infected abortion during the past three months;
• Cervical intraepithelial neoplasia until resolved;
• Uterine or cervical malignancy;
• Progestogen-sensitive tumours, e.g. breast cancer;
• Abnormal uterine bleeding of unknown etiology;
• Congenital or acquired uterine anomaly including fibroids which would interfere with insertion and / or retention of the intrauterine system (i.e. if they distort the uterine cavity);
• Acute liver disease or liver tumour;
• Hypersensitivity to the active substance or to any of the excipients.

This medicinal product should be used with caution after specialist consultation, or removal of the system should be considered if any of the following conditions exist or arise for the first time:
• migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
• exceptionally severe headache
• jaundice
• marked increase of blood pressure
• severe arterial disease such as stroke or myocardial infarction
Low-dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Kyleena. However, there is generally no need to alter the therapeutic regimen in diabetics using levonorgestrel- IUS.
Medical examination/consultation
Before insertion, a woman must be informed of the benefits and risks of this IUS, including the signs and symptoms of perforation and the risk of ectopic pregnancy. A physical examination including pelvic examination and examination of the breasts should be conducted. Cervical smear should be performed as needed, according to healthcare professional’s evaluation. Pregnancy and sexually transmitted diseases should be excluded. Genital infections should be successfully treated prior to insertion. The position of the uterus and the size of the uterine cavity should be determined. Fundal positioning is important in order to maximize the efficacy and reduce the risk of expulsion.
Insertion and removal may be associated with some pain and bleeding. The procedure may precipitate a vasovagal reaction (e.g. syncope, or a seizure in an epileptic patient).
A woman should be re-examined 4 to 6 weeks after insertion to check the threads and ensure that the system is in the correct position. Vaginal ultrasound examination may be considered to ascertain the correct position of the system. In case Kyleena cannot be located in the uterine cavity, expulsion or complete perforation should be considered and X-ray may be used. Thereafter, re-examination should be performed once a year or more frequently if clinically indicated.
This medicinal product is not for use as a post-coital contraceptive.
The use for the treatment of heavy menstrual bleeding or protection from endometrial hyperplasia during estrogen replacement therapy has not been established. Therefore, it is not recommended for use in these conditions.
Perforation
Perforation or penetration of the uterine corpus or cervix by an intrauterine contraceptive may occur, most often during insertion, although it may not be detected until sometime later, and may decrease the effectiveness of this IUS. In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound. In some of these cases, the device may be located outside of the uterine cavity. Such a system must be removed; surgery may be required. The risk of perforations may be increased in women with fixed retroverted uterus. Re-examination after insertion should follow the guidance given under the heading “Medical examination/consultation” including the consideration to use vaginal ultrasound examination to ascertain the correct position of the system 4 to 6 weeks thereafter which may be adapted as clinically indicated in women with risk factors for perforation.
Lost threads
If the removal threads are not visible at the cervix on follow-up examinations, unnoticed expulsion and pregnancy must be excluded. The threads may have been drawn up into the uterus or cervical canal and may reappear during the next menstrual period. If pregnancy has been excluded, the threads may usually be located by gently probing the cervical canal with a suitable instrument. If they cannot be found, the possibility of expulsion or perforation should be considered. Vaginal ultrasound examination may be used to ascertain the position of the system. If ultrasound is not available or is not successful, X-ray may be used to locate Kyleena.
Ectopic pregnancy
Women should be counselled on the signs, symptoms and risks of ectopic pregnancy. For women who become pregnant while using Kyleena, the possibility of an ectopic pregnancy must be considered and evaluated.
Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially in connection with missed periods or if an amenorrhoeic woman starts bleeding. Because an ectopic pregnancy may impact future fertility the benefits and risks should be carefully evaluated on an individual woman basis.
Effects on the menstrual bleeding pattern
Effects on the menstrual bleeding pattern are expected in most users. Those alterations are a result of the direct action of levonorgestrel on the endometrium and may not correlate with the ovarian activity.
Irregular bleeding and spotting are common in the first months of use. Thereafter, the strong suppression of the endometrium results in the reduction of the duration and volume of menstrual bleeding. Scanty flow frequently develops into oligomenorrhoea or amenorrhoea.
Pregnancy should be considered if menstruation does not occur within 6 weeks of the onset of previous menstruation. A repeated pregnancy test is not necessary in subjects who remain amenorrhoeic unless indicated by other signs of pregnancy.
If bleeding becomes heavier and/or more irregular over time, appropriate diagnostic measures should be taken as irregular bleeding may be a symptom of endometrial polyps, hyperplasia or cancer and heavy bleeding may be a sign of unnoticed expulsion of the IUS.
Pelvic infection
Pelvic infection has been reported during use of any IUS or IUD. While this IUS and the inserter are sterile they may, due to bacterial contamination during insertion, become a vehicle for microbial transport in the upper genital tract.
Patients should be fully evaluated for risk factors associated with pelvic infection (e.g. multiple sexual partners, sexually transmitted infections, prior history of PID). Pelvic infections such as PID may have serious consequences and may impair fertility and increase the risk of ectopic pregnancy.
As with other gynecological or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) can occur following IUD insertion, although this is extremely rare.
If a woman experiences recurrent endometritis or pelvic inflammatory disease or if an acute infection is severe or does not respond to treatment, Kyleena must be removed.
Bacteriological examinations are indicated and monitoring is recommended, even with discrete symptoms indicative of infections.
Expulsion
In clinical trials, the incidence of expulsion was low (<4% of insertions). Symptoms of partial or complete expulsion of Kyleena may include bleeding or pain. However, the system can be expelled from the uterine cavity without the woman noticing it, leading to loss of contraceptive protection. As Kyleena decreases menstrual flow, increase of menstrual flow may be indicative of an expulsion.
Risk of expulsion is increased in
– Women with history of heavy menstrual bleeding
– Women with greater than normal BMI at the time of insertion; this risk increases gradually with increasing BMI
Women should be counselled on possible signs of expulsion and how to check the threads of this IUS. A barrier contraceptive (such as a condom) should be used until the location of this IUS has been confirmed.
Partial expulsion may decrease the effectiveness. A partially expelled IUS should be removed. A new system can be inserted at the time of removal, provided pregnancy has been excluded.
Ovarian cysts/enlarged ovarian follicles
Since the contraceptive effect is mainly due to its local effects within the uterus, there is generally no change in ovulatory function, including regular follicular development, oocyte release and follicular atresia in women of fertile age. Sometimes atresia of the follicle is delayed and folliculogenesis may continue. These enlarged follicles cannot be distinguished clinically from ovarian cysts. Ovarian cysts (including haemorrhagic ovarian cysts and ruptured ovarian cysts) have been reported in clinical trials. Most of these cysts are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases, the enlarged follicles resolve spontaneously over two to three months observation. Should an enlarged follicle fail to resolve spontaneously, continued ultrasound monitoring and other diagnostic/ therapeutic measures may be appropriate. Rarely, surgical intervention may be required.
Psychiatric disorders
Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.
Precautions at time of removal
The use of excessive force/sharp instruments during removal may cause breakage of the system. After removal, the system should be examined to ensure that it is intact and has been completely removed.
See prescribing information for full details.

Very common: Headache, abdominal/pelvic pain, acne/seborrhoea, bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent bleeding, amenorrhoea, ovarian cyst, and vulvovaginitis.
Common: Depressed mood/depression, decreased libido, migraine, dizziness, nausea, alopecia, upper genital tract infection, dysmenorrhoea, breast pain/discomfort, device expulsion (complete and partial), genital discharge, and increased weight.
See prescribing information for full details.

Effects of other medicinal products on Kyleena
Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones.
Substances increasing the clearance of levonorgestrel, e.g.: Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin, and products containing St. John’s wort.
The influence of these medicinal products on the contraceptive efficacy of this IUS is not known, but it is not believed to be of major importance due to the local mechanism of action.
Substances with variable effects on the clearance of levonorgestrel, e.g.: When co-administered with sex hormones, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of the progestin.
Substances decreasing the clearance of levonorgestrel (enzyme inhibitors): Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g. fluconazole, itraconazole, ketoconazole, voriconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentrations of the progestin.
Magnetic resonance imaging (MRI)
Non-clinical testing of another levonorgestrel-IUS with the same size silver ring and T-body has demonstrated that a patient can be scanned safely after placement of Kyleena (MR conditional) under the following conditions:
• Static magnetic field of 3-Tesla or less,
• Spatial gradient field of 36000 Gauss/cm (360 T/m) or less
• Maximum whole body averaged specific absorption rate (SAR) of 4 W/kg in the First Level Controlled mode for 15 minutes of continuous scanning
In non-clinical testing, the aforementioned levonorgestrel-IUS produced a temperature rise of equal to or less than 1.8°C at a maximum whole body averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR scanning at 3 T using a transit/receive body coil.
A small amount of imaging artifact may occur if the area of interest is in the same area or relatively close to the position of Kyleena.

Pregnancy:
The use during a pregnancy is contraindicated.
If the woman becomes pregnant while using Kyleena the system should be removed as soon as possible, since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour. Removal of the IUS or probing of the uterus may also result in spontaneous abortion.
Ectopic pregnancy should be excluded.
If the woman wishes to continue the pregnancy and the system cannot be withdrawn, she should be informed about the risks and the possible consequences of premature birth to the infant. The course of such a pregnancy should be closely monitored. The woman should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever.
In addition, an increased risk of virilising effects in a female foetus because of the intrauterine exposure to levonorgestrel cannot be excluded. There have been isolated cases of masculinisation of the external genitalia of the female foetus following local exposure to levonorgestrel during pregnancy with an LNG-IUS in place.
Lactation:
In general, there appears to be no deleterious effect on infant growth or development when using any progestogen-only method after 6 weeks postpartum. A levonorgestrel-releasing intrauterine system does not affect the quantity or quality of breast milk. Small amounts of progestogen (about 0.1% of the levonorgestrel dose) pass into the breast milk in nursing mothers.  

The product is supplied in a sterile package which should not be opened until required for insertion. Each system should be handled with aseptic precautions.