Kyleena
The most frequently chosen hormonal coil: as small as Jaydess, effective for five years. Who it suits – and when another one is better.
Kyleena is the hormonal coil most often chosen in this practice – not because it is the best, but because for most women it is the most coherent compromise: as small as the smallest, and effective for almost as long as the largest. This page explains what it can do, who it is meant for and where its limits lie.
What Kyleena is
Kyleena is a T-shaped intrauterine system containing 19.5 milligrams of levonorgestrel in its hormone cylinder. It measures 28 × 30 millimetres and is inserted with an insertion tube 3.8 millimetres in diameter. It is licensed for five years of contraception. To make it easier to see on ultrasound it carries a silver-containing ring at its upper end – a detail that plays no part in everyday life but helps when the position is checked.
Hormone release begins at around 17.5 micrograms a day and falls over the time in place to about 7.4 micrograms. This decrease is accounted for: contraceptive protection remains equally reliable over the full five years.
On the Austrian market Kyleena sits between Jaydess and Mirena. That is precisely where its point lies – and why the comparison comes first.
Why it is so often the right choice
| Model | Hormone | Duration | Insertion tube | Cost per year |
|---|---|---|---|---|
| Jaydess | 13.5 mg | 3 years | 3.8 mm | €167 |
| Kyleena | 19.5 mg | 5 years | 3.8 mm | €120 |
| Mirena | 52 mg | up to 8 years | 4.4 mm | €94 |
The table shows the thinking in one line: Kyleena has the same external dimensions and the same thin insertion tube as Jaydess – the same advantage during insertion, that is – but lasts five years instead of three. Anyone choosing Jaydess accepts lying on the couch again after three years; Kyleena pushes that back by two years without insertion becoming any more unpleasant.
Compared with Mirena, Kyleena brings less than half the hormone and a noticeably thinner tube. Anyone choosing Mirena does so for a particular reason – usually because of very heavy bleeding or as the progestogen component of hormone replacement therapy. Where that reason is absent, there is little to be said for the larger coil.
How reliably it prevents pregnancy
The Pearl index of Kyleena is 0.29 in the first year, and cumulatively about 1.4 over five years. That means: of a hundred women using Kyleena for five years, a little over one becomes pregnant. For comparison: with the combined pill in typical use it is seven per year, and thus a multiple of that over five years.
This difference has nothing to do with the potency of the preparations but with everyday life. A pill can be forgotten; a coil cannot. With vomiting or diarrhoea the effect of the pill is uncertain – the coil is not affected. Antibiotics that could impair the pill's protection play no part here. Everything that goes wrong in practice cannot go wrong with a coil.
The complete comparison with all the methods is in the contraception comparison, and that of all five coils in the coil comparison.
How Kyleena works
The levonorgestrel is released directly into the uterus and acts overwhelmingly there. The level in the blood stays very low – considerably lower than under a progestogen-only pill and many times lower than under the three-monthly injection. That is why hormonal side effects are rarer with the coil than with contraceptives that distribute the same hormone through the bloodstream.
Three effects work together:
- The mucus in the cervix becomes thick and practically impenetrable to sperm – the most important mechanism.
- Sperm that do get through lose their motility.
- The lining of the uterus stays thin, so that an egg could not implant there.
Ovulation as a rule continues with Kyleena. For many women that is precisely an argument in its favour: their own cycle with its hormonal fluctuations carries on, only the bleeding becomes lighter. Anyone who does not want that but is hoping precisely for the cycle to be switched off is better advised to choose another method.
What happens to the bleeding – year by year
This question decides the choice in consultations more often than any other. The figures from the licensing studies are remarkably stable and can be summarised well.
Months one to six: irregular spotting is the rule. The number of days with bleeding and spotting is higher in the first months than before – often ten to fifteen days in the first month. This is the phase in which most women doubt their decision, and it is the phase that passes.
From month six: the days of bleeding decrease markedly, and the bleeding becomes lighter and shorter. Period pain improves noticeably in many women.
After a year: in about 23 out of a hundred women the bleeding stops altogether. In the rest it is as a rule lighter than before.
After three years: the proportion of women with no bleeding rises further to around a third and then stays stable.
The absence of bleeding is not a sign that something is building up. Under the local action of the hormone the lining simply does not build up; there is nothing there that would have to be shed. For many women that is the most pleasant part of the method. There is nothing medically worrying about it, and after removal the cycle comes back.
Who Kyleena particularly suits
- Women who have not given birth. The thin insertion tube makes insertion considerably more bearable. The old idea that a coil is something for women who have completed their families is professionally outdated.
- After a thrombosis, with migraine with aura and for smokers over 35. Kyleena contains no oestrogen and does not increase the risk of thrombosis.
- While breastfeeding. Milk production is not impaired. It is usually inserted twelve weeks after the birth.
- Where the pill is not tolerated – headaches, low mood and loss of libido on the combined pill often improve with the coil, because the hormone level in the blood is so much lower.
- With moderate but troublesome bleeding. Mirena is licensed for the treatment of very heavy bleeding; where the burden is moderate, Kyleena is often enough.
When another choice is better
- With very heavy bleeding or endometriosis Mirena is the better choice: it is licensed for the treatment of heavy bleeding and suppresses the lining more strongly.
- In hormone replacement therapy only Mirena comes into question as the progestogen component.
- Where hormones are out of the question – as a matter of conviction or because of a history of breast cancer – the copper or gold coil remains.
- If you want a child in one or two years, the sums are worth doing: inserting a coil for five years and removing it after eighteen months is possible but expensive.
It is not inserted in pregnancy, with an acute genital infection, with unexplained bleeding, with malformations or large fibroids that distort the cavity of the uterus, or with certain liver diseases.
Kyleena or a copper coil?
This question comes up almost as often as the one about the model, and it can be answered more clearly than many expect. Both coils sit in the same place and are similarly reliable – 0.29 against 0.8 in the Pearl index. What distinguishes them is their effect on bleeding, and that goes in exactly opposite directions.
The copper coil works through copper ions, entirely without hormones. The cycle is fully preserved, ovulation takes place, the bleeding comes as before – only usually heavier, longer and more painful, above all in the first months. For women who do not want hormones or do not tolerate them, it is the method of choice. For women who bleed heavily anyway, it is almost always the wrong one.
Kyleena does the opposite: lighter, shorter, less painful bleeding, and in just under a quarter none at all. The price for that is a small amount of progestogen, which stays predominantly local, and the unsettled early phase.
In practice this means: anyone whose main objection is to contraception with hormones takes copper. Anyone whose main objection is to the bleeding takes Kyleena. Anyone who wants both – no hormones and no heavy bleeding – has to weigh up two aims, and that is what the conversation is for. Both stand side by side with price, duration and effect in the coil comparison.
What Kyleena does not do
It does not protect against sexually transmitted infections – for that the condom remains irreplaceable. It does not treat a disturbance of the cycle whose cause lies elsewhere: where polycystic ovary syndrome, a thyroid disorder or iron deficiency anaemia is suspected, that cause belongs clarified first. And it does not replace screening: the cervical smear and the yearly check continue independently of contraception – what is due when is shown by the screening planner.
The procedure: two appointments
The first appointment is about the conversation and the preliminary examination: history, bleeding pattern, family planning, then ultrasound to assess the size and position of the uterus, a wet mount and swabs. At the end it is settled which model fits and that there is no infection that could be carried upwards during insertion.
At the second appointment it is inserted. The procedure takes a few minutes: the cervix is prepared, the coil is introduced in its tube and released, the threads are trimmed, the position is confirmed by ultrasound. A convenient time is at the end of or shortly after a period – the cervix is then somewhat softer of its own accord, and pregnancy is ruled out.
That the two do not take place on the same day is deliberate. The separation is the reason why the second appointment is short: there is nothing left to discuss, nothing to wait for and nothing to rule out.
What insertion feels like
Unpleasant – that belongs said honestly. Expect a short, strong cramping pain at the moment when the insertion tube passes the cervix, and after that a dragging sensation like strong period pain which eases over hours. A painkiller an hour beforehand makes sense. Some women take the rest of the day off; many go back to work.
How severe it turns out to be depends considerably on how carefully things are prepared and how much time is allowed. The diameter of the tube also plays a part – 3.8 against 4.4 millimetres sounds like little and is not. That is exactly why Kyleena is so often the recommendation for women who have not given birth.
Checks and everyday life
A check takes place four to six weeks after insertion, and yearly after that. Ultrasound shows whether the coil is in the right place; it can move or be expelled, most likely in the first months and most likely during a period. This happens in about two to five out of a hundred women.
In everyday life there are hardly any restrictions. Sport, sauna and swimming are possible without restriction, and so are tampons. With a menstrual cup the suction should be deliberately released before removing it, so that it does not pull on the threads. In the first week after insertion, baths, swimming pools and tampons are advised against, because the cervix is still slightly open.
Side effects and risks
The commonest unwanted effects are the spotting of the first months already described, together with headaches, breast tenderness, acne and mood swings in some women. They are considerably rarer than with preparations that distribute the same hormone through the bloodstream, but they do occur. Functional cysts on the ovary occur somewhat more often; they are mostly harmless and disappear by themselves.
More serious events are rare. Perforation of the wall of the uterus during insertion is of the order of one in a thousand and, if recognised in time, mostly without consequences; it is commoner shortly after a birth and while breastfeeding. An ascending infection is somewhat more likely in the first three weeks after insertion and not afterwards – the cause is not the coil but an infection already present that is carried upwards. It is precisely against this that the consultation appointment with its swabs protects. Fever, increasing lower abdominal pain or foul-smelling discharge during this time belong investigated the same day.
Costs in Vienna
The insertion appointment with Kyleena costs €600 at this private practice. That includes the examination, the ultrasound, a pregnancy test, the wet mount, the medical preparation, the insertion and the coil itself. The preceding contraception consultation with swabs is charged at €250.
Calculated over five years that is €120 a year, or ten euros a month – less than most packets of pills cost, with considerably greater reliability. You submit the invoice to your health insurance fund, which reimburses 80 per cent of the corresponding public tariff. Contraceptives themselves are not covered by public insurance in Austria. All the amounts are on the page fees.
If you are insured outside Austria, the practical route is the same: you pay at the practice and receive an itemised invoice in a form your insurer can process. What is reimbursed and at what rate is a matter between you and your insurer; the practice cannot settle directly with foreign funds. Details on this are on the page health insurance and reimbursement.
After five years
Once the licensed duration has expired, Kyleena has to be changed – protection is no longer assured after that. The change and the new insertion take place in one appointment: the old one out, the new one in. Removal takes seconds and hurts considerably less than insertion.
If instead you want to conceive: fertility returns immediately. Unlike after the three-monthly injection there is no delay; pregnancy is possible in the very first cycle afterwards. Folic acid should be started four weeks before the planned conception and not afterwards – the ovulation calculator helps with the planning.
What happens next
Whether Kyleena, Jaydess or Mirena is the right one is decided by your history, your bleeding pattern and your family planning – not by a table. The next step is therefore the contraception consultation. Arranging an appointment, or compare beforehand: coil comparison, Jaydess and the hormonal coil in overview.
Patient information leaflet, Kyleena 19.5 mg
This is a translation. Below is the manufacturer's patient information leaflet for Kyleena 19.5 mg intrauterine delivery system (levonorgestrel), Bayer, rendered into English for convenience. The authoritative text is the German original, which is reproduced word for word on the German version of this page and enclosed with the product. This translation replaces neither that leaflet nor the conversation at the practice.
Package leaflet: information for the user. Kyleena 19.5 mg intrauterine delivery system (levonorgestrel)
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you personally. Do not pass it on to others.
- If you get any side effects, talk to your doctor or the healthcare staff. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Kyleena is and what it is used for
- What you need to know before you use Kyleena
- How to use Kyleena
- Possible side effects
- How to store Kyleena
- Contents of the pack and other information
1. What Kyleena is and what it is used for
Kyleena is used to prevent pregnancy (contraception) for a period of up to five years. Kyleena is a T-shaped intrauterine delivery system (IUS) which, after insertion into the uterus, slowly releases a small amount of the hormone levonorgestrel.
Kyleena works by reducing the monthly growth of the lining of the uterus and thickening the cervical mucus. This prevents sperm and egg cells from coming into contact with one another, which prevents fertilisation of the egg by the sperm.
2. What you need to know before you use Kyleena
General information
Before you can use Kyleena, your doctor will ask you some questions about your personal medical history. This leaflet describes various situations in which Kyleena has to be removed or in which the reliability of Kyleena may be reduced. In such situations you should either not have sexual intercourse or use a condom or another barrier method.
Like other hormonal contraceptives, Kyleena does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Kyleena is not suitable for emergency contraception (as a post-coital contraceptive).
Do not use Kyleena:
- if you are pregnant (see the section “Pregnancy, breastfeeding and fertility”).
- if you currently have pelvic inflammatory disease (PID; an infection of the female reproductive organs) or have had this condition repeatedly in the past.
- if you have an illness associated with an increased susceptibility to pelvic infections.
- if you have an infection of the lower genital tract (an infection of the vagina or the cervix).
- if you have had an infection of the uterus after the birth of a child, a termination or a miscarriage in the last 3 months.
- if you currently have cell changes of the cervix.
- if you have cancer of the cervix or of the uterus, or such cancer is suspected in you.
- if you have a tumour whose growth is sensitive to progestogen, for example breast cancer.
- if you have unexplained vaginal bleeding.
- if you have a malformation of the cervix or of the uterus, including fibroids, which distorts the cavity of the uterus.
- if you have acute liver disease or a liver tumour.
- if you are allergic to levonorgestrel or to any of the other ingredients of this medicine listed in section 6.
Warnings and precautions
Talk to your doctor before using Kyleena if you
- have diabetes. It is generally not necessary to change your diabetes medication while using Kyleena, but this may have to be reviewed by your doctor.
- suffer from epilepsy. A seizure may occur during insertion or removal.
- have previously had an ectopic or extrauterine pregnancy (a pregnancy outside the uterus).
Also talk to your doctor if one of the following conditions is present before using Kyleena or occurs for the first time while using Kyleena:
- migraine with visual disturbance or other symptoms suggesting transient cerebral ischaemia (a temporary interruption of the blood supply to the brain)
- exceptionally severe headache
- jaundice (yellowing of the skin, the whites of the eyes and/or the nails)
- a marked rise in blood pressure
- severe vascular disease such as stroke or heart attack
The following signs and symptoms may indicate an extrauterine pregnancy, which is why you must see your doctor immediately (see also the section “Pregnancy, breastfeeding and fertility”):
- Your periods have stopped and you have persistent bleeding or pain.
- You have severe or persistent lower abdominal pain.
- You have the normal signs of pregnancy but also have bleeding and feel dizzy.
- A pregnancy test you have carried out is positive.
Contact your doctor immediately if you experience the following (see section 4):
- severe pain (like period cramps) or heavy bleeding after insertion, or if you have pain or bleeding lasting longer than a few weeks. This may be a sign of an infection or a perforation, for example, or an indication that Kyleena is not in the correct position.
- if you can no longer feel the threads in your vagina. This may indicate expulsion or perforation. You can check this by carefully introducing a finger into your vagina and feeling for the threads at the end of your vagina near the opening of the uterus (the cervix). Do not pull on the threads, as you could pull Kyleena out by accident. Avoid sexual intercourse or use barrier methods (such as a condom) until your doctor has checked whether the IUS is still in the correct position.
- if you or your partner can feel the lower end of Kyleena. Avoid sexual intercourse until your doctor has checked that the IUS is correctly in place.
- if your partner feels the removal threads during sexual intercourse.
- if you think you are pregnant.
- if you have persistent abdominal pain, fever or unusual discharge from the vagina; this may be a sign of an infection. Infections have to be treated immediately.
- if you have pain or discomfort during sexual intercourse; this may be a sign of an infection or an ovarian cyst, for example, or an indication that Kyleena is not in the correct position.
- if sudden changes occur in your periods (for example if you have little or no bleeding and begin to have persistent bleeding or pain, or begin to bleed heavily); this may indicate, for example, that Kyleena is not in the correct position or has been expelled.
The use of sanitary towels is recommended. If you use tampons, change them carefully and do not pull on the threads of Kyleena.
Psychiatric disorders
Some women using hormonal contraceptives such as Kyleena report depression or depressed mood. Depression can be serious and may occasionally lead to suicidal thoughts. If you experience mood changes and depressive symptoms, seek medical advice from your doctor as soon as possible.
Children and adolescents
Kyleena is not indicated for use before the first menstrual period (menarche).
Other medicines and Kyleena
Tell your doctor if you are taking or using, have recently taken or used, or intend to take or use any other medicines.
Pregnancy, breastfeeding and fertility
Pregnancy
Kyleena must not be used during pregnancy.
In some women periods may stop while using Kyleena. An absent period is not necessarily a sign of pregnancy. If you do not have your period and have other signs of pregnancy, you should see your doctor for examination and carry out a pregnancy test.
If you have not had a period for six weeks and are worried, consider a pregnancy test. If it is negative, no further test needs to be carried out unless you have other signs of pregnancy.
If you become pregnant with Kyleena in place, contact your doctor immediately so that Kyleena can be removed. There is a risk of spontaneous miscarriage if Kyleena is removed during pregnancy.
If you leave Kyleena in place during pregnancy, the risk of miscarriage, infection or premature labour is increased. Talk to your doctor about the risks of continuing the pregnancy.
If you want to become pregnant, you must contact your doctor so that Kyleena can be removed.
Extrauterine pregnancy (pregnancy outside the uterus)
It is unusual to become pregnant while using Kyleena. If, however, you do become pregnant while using Kyleena, the risk of a pregnancy outside the uterus (an extrauterine or ectopic pregnancy) is increased. Women who have already had an extrauterine pregnancy, an operation on the fallopian tubes or a pelvic infection are at greater risk of such a pregnancy. An extrauterine pregnancy is a serious condition and must be treated medically without delay (see section 2, “Warnings and precautions, signs and symptoms”) and can lead to infertility.
Breastfeeding
You can use Kyleena while breastfeeding. Levonorgestrel (the active substance in Kyleena) has been detected in small amounts in the breast milk of breastfeeding women. However, no adverse effects on the growth and development of the infant or on the amount or quality of the breast milk have been observed.
Fertility
After Kyleena is removed, your fertility returns to its normal level.
Driving and using machines
Kyleena has no influence on the ability to drive or to use machines.
3. How to use Kyleena. Insertion of Kyleena
Kyleena can be inserted:
- within seven days of the start of your period,
- immediately after a termination of pregnancy in the first trimester (the first three months of a pregnancy), provided there is no genital infection (an infection of the reproductive organs),
- after a birth, but only once the uterus has returned to its normal size, and not earlier than 6 weeks after delivery (see section 4, “Possible side effects – perforation”).
The examination by your doctor before insertion may include:
- a smear from the cervix (Pap test),
- an examination of the breasts,
- other tests as required, for example for infections including sexually transmitted diseases. Your doctor will also carry out a gynaecological examination in order to determine the position and size of your uterus.
After a gynaecological examination the following happens:
- An instrument called a speculum is introduced into the vagina and the cervix may be cleaned with an antiseptic solution. Kyleena is then introduced into the uterus through a thin, flexible plastic tube (the inserter). Before insertion the cervix may be anaesthetised locally.
- Some women feel dizzy or faint during or after the insertion, or during the removal, of Kyleena.
- During or shortly after insertion you may experience slight bleeding.
After Kyleena has been inserted, your doctor should give you a patient card as a reminder for the follow-up examinations. Bring it to each of your appointments.
Follow-up examinations:
You must have your Kyleena checked 4 to 6 weeks after insertion and regularly thereafter, but at least once a year. Your doctor will decide how often and which follow-up examinations are necessary in your particular case. If you have been given a patient card as a reminder by your doctor, bring it to every check-up.
Removal of Kyleena
Kyleena must be removed at the latest at the end of the fifth year of use. Kyleena can be removed easily by your doctor at any time; pregnancy is possible afterwards. Some women feel dizzy or faint during or after Kyleena is removed. You may have pain and bleeding when Kyleena is removed.
If pregnancy is not desired, Kyleena must not be removed after the seventh day of the menstrual cycle unless you use other contraceptives (for example condoms) for at least seven days before Kyleena is removed.
If your periods are irregular or absent, use a barrier method for at least seven days before removal. A new Kyleena can also be inserted immediately after removal. In that case no additional protection is necessary.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor immediately if you notice any of the following symptoms:
allergic reactions including rash, hives (urticaria) and angioedema (sudden swelling of, for example, the eyes, mouth or throat). See also section 2 on when to contact your doctor immediately.
What follows is a list of possible side effects ordered by frequency:
Very common side effects: may affect more than 1 in 10 people
- headache
- abdominal/pelvic pain
- acne/oily skin
- changes in bleeding including increased and decreased menstrual bleeding, spotting, infrequent periods and absent bleeding (see also the section below on irregular and infrequent bleeding)
- ovarian cyst (see also the section below on ovarian cysts)
- inflammation of the external genitals and the vagina (vulvovaginitis)
Common side effects: may affect up to 1 in 10 people
- depressed mood/depression
- migraine
- nausea
- infections of the upper genital tract
- painful periods
- breast pain/discomfort
- expulsion of the IUS (complete and partial) – see the section below on expulsion
- hair loss
- genital discharge
Uncommon side effects: may affect up to 1 in 100 people
- excessive body hair
- perforation of the uterus (see also the section below on perforation)
Description of selected side effects. Irregular or infrequent bleeding
It is likely that Kyleena will affect your menstrual cycle. It may change your periods, so that you experience spotting (a small amount of blood), irregular, shorter or longer periods, lighter or heavier bleeding, or no bleeding at all.
You may have bleeding and spotting between periods, particularly in the first 3 to 6 months. Sometimes the bleeding is heavier than usual at first.
Overall it is likely that the amount of bleeding and the number of days of bleeding will gradually decrease each month. In some women the periods eventually stop altogether.
Because of the action of the hormone, the monthly thickening of the lining of the uterus may not occur, which is why there is nothing that could be shed as a period. This does not necessarily mean that you have reached the menopause or are pregnant. Your own hormone levels usually remain normal.
After the system is removed, your periods should soon return to normal.
Pelvic infection
The Kyleena inserter and Kyleena itself are sterile. Nevertheless the risk of a pelvic infection (infections of the lining of the uterus or of the fallopian tubes) is increased at the time of insertion and in the first 3 weeks afterwards.
In users of an IUS, pelvic infections are often connected with existing sexually transmitted diseases. The risk of infection is increased if you or your partner have several sexual partners or if you have previously had pelvic inflammatory disease (PID).
Pelvic infections must be treated without delay.
Pelvic inflammation such as PID can have serious consequences and impair fertility as well as increasing the risk of a future extrauterine pregnancy (a pregnancy outside the uterus).
In extremely rare cases a serious infection or sepsis (a very serious general infection which can be fatal) can occur shortly after insertion.
With recurrent PID, or with a severe infection or one that does not respond to treatment, Kyleena must be removed.
Expulsion
The muscular contractions of the uterus during a period can sometimes cause the IUS to move or be expelled. It is rare but possible for Kyleena to slip out during your period without your noticing.
It is also possible for Kyleena to be partly expelled from the uterus, that is, for it to have moved but not been expelled completely (you and your partner may notice this during sexual intercourse). If Kyleena has been expelled completely or partly, you are not protected against pregnancy.
Perforation
Penetration or perforation of the wall of the uterus can occur when Kyleena is inserted, although the perforation may only be noticed later. If Kyleena passes outside the cavity of the uterus, it cannot effectively prevent pregnancy and must be removed as soon as possible. An operation may be necessary in order to remove Kyleena.
The risk of perforation is increased in breastfeeding women and in women in whom Kyleena is inserted up to 36 weeks after a birth, and may be increased in women whose uterus is fixed and tilted backwards (a fixed retroverted uterus). If you suspect a perforation, see a doctor immediately and tell them that you have a Kyleena in place, particularly if it is not the same doctor who inserted it.
Ovarian cyst
Because the contraceptive effect of Kyleena rests mainly on its local action in the uterus, ovulation generally continues to take place while Kyleena is being used. An ovarian cyst may sometimes develop. In most cases this causes no symptoms. An ovarian cyst may require medical treatment or, less often, a medical procedure; in most cases, however, it disappears by itself.
Reporting of side effects
If you get any side effects, talk to your doctor or the healthcare staff. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the
Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen)
Traisengasse 5
1200 Vienna
Fax: + 43 (0) 50 555 36207
Website: http://www.basg.gv.at/
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Kyleena
This medicine requires no special storage conditions. Keep this medicine out of the sight and reach of children.
Do not open the blister. The pack may only be opened by your doctor or the healthcare staff.
Do not use this medicine after the expiry date stated on the outer carton and on the blister pack after “Use by”. The expiry date refers to the last day of the month stated.
6. Contents of the pack and other information
What Kyleena contains
The active substance is levonorgestrel. The intrauterine delivery system contains 19.5 mg of levonorgestrel.
The other ingredients are:
- polydimethylsiloxane elastomer
- colloidal anhydrous silica
- polyethylene
- barium sulphate
- polypropylene
- copper phthalocyanine
- silver
What Kyleena looks like and contents of the pack
Kyleena is a T-shaped intrauterine delivery system (IUS). The vertical arm of the white T-body contains a drug reservoir with levonorgestrel. Two blue removal threads are attached to the loop at the lower end of the vertical arm. In addition the vertical stem contains a silver ring near the horizontal arms, which is visible on ultrasound examination.
Pack size:
- 1 x 1 intrauterine delivery system.
- 5 x 1 intrauterine delivery system.
Not all pack sizes may be marketed. Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Bayer Austria Ges.m.b.H.
1160 Vienna
Manufacturer:
Bayer Oy
Pansiontie 47
20210 Turku
Finland
Authorisation no.: 137280
Frequently asked questions
How quickly does Kyleena work?
If it is inserted in the first seven days of the cycle, immediately. At a later point additional protection with a condom for seven days makes sense.
Do you put on weight with Kyleena?
In the licensing studies the development of weight did not differ substantially from that without hormonal contraception. Individual women report otherwise; in case of doubt it helps to compare your weight before insertion and six months afterwards rather than relying on an impression.
Can Kyleena move without my noticing?
Yes, which is why there is a check after four to six weeks and yearly after that. You can also feel for the threads yourself from time to time; if they can no longer be found or have become noticeably longer, make an appointment.
What is the difference between Kyleena and Mirena in everyday life?
Mirena reduces bleeding more strongly and stays in place longer, but is larger and contains more than twice the amount of hormone. Kyleena is smaller and lower in hormone with almost the same reliability. Anyone coming because of very heavy bleeding gets Mirena; anyone wanting contraception mostly gets Kyleena.
Does Kyleena still make sense at 40?
Yes. Contraception remains necessary until the end of the menopause. Anyone who additionally wants hot flushes treated should talk about Mirena: it can serve as the progestogen component of hormone replacement therapy, Kyleena cannot.
Does Kyleena protect against sexually transmitted infections?
No. For that the condom is the only method – with changing partners, therefore, in addition.
Sources
- Summary of product characteristics for Kyleena, Bayer Austria, as at 2025.
- Gemzell-Danielsson K et al.: A randomised phase II study of two low-dose levonorgestrel-releasing intrauterine systems. Human Reproduction 2012;27(4):1131–1139.
- Faculty of Sexual & Reproductive Healthcare: Intrauterine Contraception. FSRH Clinical Guideline, London 2023.
- Trussell J: Contraceptive failure in the United States. Contraception 2011;83(5):397–404.
- World Health Organization: Medical eligibility criteria for contraceptive use. 5th edition, Geneva 2015.
This text is general information and cannot replace a consultation: it does not know your history and cannot examine you. If something about your situation differs from what is described here, that difference is what matters.
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