levonorgestrel intrauterine delivery system
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Kyleena. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you using Kyleena against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet and the card describing the date of insertion, batch number, and latest date of removal in a safe place. You may need to read it again.
WHAT KYLEENA IS USED FOR
Kyleena consists of a small T-shaped frame made from a plastic called polyethylene. This carries 19.5 mg levonorgestrel, a hormone used in many contraceptive pills. The hormone is contained within a substance called dimethylsiloxane/methylvinylsil oxane cross linked elastomer and is surrounded by a membrane (skin) also made of the same elastomer.
This structure provides a system for releasing the hormone gradually into the uterus (womb).
There are two fine threads, made of blue pigment and polyethylene, attached to the bottom of the frame. These allow easy removal and allow you or your doctor to check that the system is in place.
Kyleena is used for the prevention of pregnancy. It is placed inside the womb where it slowly releases the hormone over a period of five years or until it is removed.
The hormone in Kyleena prevents pregnancy by:
- controlling the monthly development of the womb lining so that it is not thick enough to support a pregnancy
- making the normal mucus in the cervical canal (opening to the womb) thicker, so that the sperm cannot get through to fertilise the egg
- there are also local effects on the lining of the womb caused by the presence of the T-shaped frame – since Kyleena is an intrauterine system (IUS)
- affecting the movement of sperm inside the womb, preventing fertilisation.
Kyleena is not an emergency contraceptive.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
BEFORE YOU USE KYLEENA
Not all women can use Kyleena. All products have benefits and risks. If you are unsure if Kyleena is suitable for you, discuss this with your doctor.
When you must not use it
Do not use Kyleena if you have an allergy to:
- levonorgestrel, the active ingredient in Kyleena
- any of the inactive ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty in breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not use this medicine if you are pregnant.
Do not give it to a child.
Do not use Kyleena and speak to your doctor if you have or have had any of the following medical conditions:
- if you have pelvic inflammatory disease or have had recurrent pelvic inflammatory disease in the past (infection of the female reproductive organs)
- if you have conditions associated with an increased risk of developing pelvic infections
- if you have a lower genital tract infection that has not been successfully treated by your doctor
- an infection of the womb following childbirth or after an abortion in the last three months
- infection or cell abnormalities in the cervix
- tumours in the cervix or womb
- progestogen dependent tumours
- undiagnosed vaginal bleeding
- abnormal cervix or womb, or fibroids which distort the cavity of the womb
- liver disease or liver tumours
Do not use this medicine after the expiry date printed on the pack. If it has expired or is damaged, return it to your pharmacist for disposal. The expiry date is printed on the carton and sachet after “To be inserted before” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month by which it should be inserted.
Do not use this medicine if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you start to use it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Before insertion, your doctor will inform you of the benefits and risks of Kyleena. A physical examination including pelvic examination, examination of the breasts and a Pap smear should be performed.
Your doctor should also rule out pregnancy and sexually transmitted infections (STIs), and any genital infections should be treated successfully before insertion.
Your doctor will also need to do a gynaecological examination to determine the position and the size of your womb.
Your doctor may consider removal of the system if any of the following conditions exist or arise for the first time. Kyleena should be used with caution after specialist consultation.
- migraine with visual disturbances or other symptoms which may be signs of a temporary blockage of blood supply to the brain
- severe headaches
- jaundice (yellowing of the skin and eyes)
- increase of blood pressure
- stroke or heart attack
- blood clots in the legs (deep vein thrombosis), the lungs (pulmonary embolism) or other parts of the body.
Tell your doctor if you have any of the following conditions, Kyleena may be used with caution:
- if you were born with heart disease (congenital) or valvular heart disease
- diabetes, there is generally no need to alter your diabetic medication while using Kyleena but this may need to be checked by your doctor
Pelvic infections have been reported with the use of intrauterine delivery systems such as Kyleena. You have an increased risk of pelvic infections if you or your partner have multiple sexual partners, STIs or a history of pelvic inflammatory disease. Pelvic infections may impair fertility and increase the risk of ectopic pregnancy.
Pain, bleeding or dizziness may occur when Kyleena is placed or removed. If you have epilepsy, tell your doctor because seizures can occur during placement or removal.
If you have not told your doctor about any of the above, tell them before you start using Kyleena.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Kyleena may interfere with each other. These include:
- medicines to treat high blood pressure, chest pain and/or irregular heartbeats such as verapamil, diltiazem
- medicines used to treat epilepsy such as phenytoin, barbiturates, primidone, carbamazepine
- rifampicin for the treatment of tuberculosis
- macrolide antibiotics (e.g. clarithromycin, erythromycin)
- herbal medicines containing St John’s Wort
- medicines used to treat HIV such as ritonavir or nevirapine
- some medicines used to treat Hepatitis C Virus (HCV) such as boceprevir, telaprevir
- medicines used to treat fungal infections such as ketoconazole, itraconazole, voriconazole, fluconazole
- grapefruit juice
These medicines may be affected by Kyleena or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
HOW TO USE KYLEENA
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions given, ask your doctor or pharmacist for help.
How to use it
Kyleena is inserted by a professional, experienced in the insertion of IUSs.
When to use it
The system should be inserted within seven days from the beginning of your period. If you already have the system and it is time to replace it with a new one, you do not need to wait for your period.
Kyleena can be inserted immediately after a first trimester abortion. It should not be used until the womb has returned to normal size after giving birth and no earlier than 6 weeks after delivery.
WHILE USING KYLEENA
You should be protected from pregnancy as soon as Kyleena is placed. The current recommendation is to wait about 24 hours after having the Kyleena inserted before having sexual intercourse.
You may feel faint after Kyleena is placed. This is normal and your doctor will tell you to rest for a while. In rare cases, part or all of the system could penetrate the wall of the womb. If this happens, Kyleena needs to be removed.
You should have Kyleena checked usually 4-12 weeks after it is placed and then once a year until it is removed. It can stay in place for five years.
Your doctor can remove the system at any time and removal is usually easy. Kyleena should be removed before the seventh day of the menstrual cycle unless another form of contraception is used in the week leading up to the removal. Intercourse during this week could lead to pregnancy after Kyleena is removed.
Kyleena does not protect against HIV infection (AIDS) and other STIs. Additional methods should be used (i.e. condoms) to prevent transmission of STIs.
The removal threads may be felt by the partner during sexual intercourse.
Magnetic resonance imaging (MRI)
The vertical stem of the IUS contains a silver ring. Before you have an MRI, tell any other doctors who treat you that you are using Kyleena, an intrauterine system. Kyleena can be scanned with MRI only under specific conditions.
Expulsion
If the system comes out either partially or completely you may not be protected against pregnancy. It is rare but possible for this to happen without you noticing during your menstrual period. The muscular contractions of the womb during menstruation may sometimes push the IUS out of place or expel it. This is more likely to occur if you are overweight or have heavy periods.
Possible symptoms of an expulsion are pain and increased amount of bleeding. If you have signs indicative of an expulsion or you cannot feel the threads, you should either avoid intercourse or use another contraceptive (e.g. condoms) and consult your doctor.
After each menstrual period or once a month, you should feel for the two thin threads attached to the lower end of the system. Your doctor will show you how to do this. Do not pull on the threads because you may accidentally pull it out. If you cannot feel the threads, go to your doctor.
You should see your doctor if you can feel the lower end of the system itself or you or your partner feel pain or discomfort during sexual intercourse.
If Kyleena is expelled, speak to you doctor immediately to receive guidance surrounding ongoing contraception and also what to do with the expelled system.
Bleeding patterns
Many women have frequent spotting or light bleeding in addition to their periods for the first 3-6 months after they have had Kyleena inserted. Overall, you are likely to have a gradual reduction in the number of bleeding days and in the amount of blood loss. Some women eventually find that their periods stop altogether.
Tell your doctor if bleeding remains heavy or irregular.
Perforation
Kyleena can perforate the wall of the womb (most often during placement). The risk of perforation increases in breastfeeding women and in postpartum (after giving birth) insertions. The risk may also be increased in women with a fixed retroverted uterus (tilted womb). If this happens the IUS must be removed as soon as possible. If you experience excessive pain or bleeding during or after insertion, or any time while you are using Kyleena, tell your doctor immediately.
Ectopic pregnancy
It is very rare to become pregnant while using Kyleena. However if you become pregnant while using Kyleena, the risk of an ectopic pregnancy (where the foetus is carried outside of your womb) is increased.
The risk of an ectopic pregnancy happening is lower than for women using no contraception.
Although the rate of pregnancy is low, if you suspect you are pregnant, you should see your doctor straight away.
Ectopic pregnancy can cause internal bleeding, infertility, and death. It is a serious condition that requires immediate medical attention.
The following symptoms could mean that you may have an ectopic pregnancy and you should see your doctor immediately:
- your menstrual periods cease and then you start having persistent bleeding or pain
- you have vague or very bad pain in your lower abdomen
- you have normal signs of pregnancy but you also have bleeding and feel dizzy
There are also risks if you get pregnant while using Kyleena and the pregnancy is in the womb. Miscarriage and premature delivery can occur with pregnancies that continue with an intrauterine device or system (IUD/IUS). Because of this, your doctor may try to remove Kyleena, even though removing it may cause a miscarriage. If Kyleena cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy, and possible effects of the hormone on the developing baby.
If you continue your pregnancy, see your doctor regularly. Call your doctor right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection. It is not known if Kyleena can cause long-term effects on the foetus if it stays in place during a pregnancy.
Pelvic infections
The Kyleena system and insertion technique have been designed to minimise the risk of infections. Despite this, there is an increased risk of pelvic infection immediately after and during the first month after insertion. Pelvic infections can occur with contamination of the IUS. You have an increased risk of pelvic infections if you or your partner has multiple sexual partners, STIs or a history of pelvic inflammatory disease. When having sex with anybody who is not a long-term partner, a condom should be used to minimise the risk of infection with HIV, hepatitis B and other STIs.
Pelvic infections must be treated promptly. Pelvic infections may impair fertility and increase the risk of ectopic pregnancy.
Kyleena must be removed if there are recurrent pelvic infections or if an infection does not respond to treatment within a few days. Tell your doctor immediately if you have persistent lower abdominal pain, fever, pain during sexual intercourse or abnormal bleeding.
As with other gynaecological or surgical procedures, severe infections or sepsis can occur following IUD insertions.
Ovarian Cysts
Ovarian cysts or enlarged group of cells (follicles) have been reported with the use of Kyleena and may cause pelvic pain or pain during intercourse. You may not experience any symptoms with ovarian cysts or follicles. In most cases, the follicles resolved spontaneously. Your doctor will monitor you while you are using Kyleena. Keep all of your doctor’s appointments.
Breast cancer
Breast cancer has been detected slightly more often in women who use combined oral contraceptives (the Pill) compared to women of the same age who do not use the Pill. It is not known whether the difference is caused by the Pill or whether cancers were detected earlier in Pill users. The evidence is not conclusive for progestogen-only presentations such as Kyleena. Should breast cancer be diagnosed, your doctor may consider removal of Kyleena.
If you are breastfeeding
There is a small amount of the progestogen hormone levonorgestrel, which will be absorbed by babies who are breastfeeding when Kyleena is used. This is an equivalent amount to that received by babies when the mother is using the minipill (a progestogen only contraceptive). There has been extensive experience with the minipill during breastfeeding, indicating no harmful effects to breastfed babies.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Kyleena.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
During placement or removal of Kyleena, the following side effects have been reported: pain, bleeding, dizziness and fainting.
Side effects are most common during the first months after the system is placed and decrease as time goes on. It is normal to experience changes in menstrual patterns during the use of Kyleena. The changes may include spotting, shorter or longer menstrual periods, irregular bleeding, prolonged periods of no bleeding at all, heavy flow and menstrual pain.
Tell your doctor or pharmacist if you notice any of the following, particularly if they worry you:
- headache
- abdominal/pelvic pain
- acne, oily skin
- bleeding changes including increased or decreased menstrual bleeding, spotting, infrequent or light periods, absence of bleeding
- itching, redness and/or swelling of the vagina
- depressed mood/depression
- migraine
- nausea
- hair loss or excessive hairiness
- vaginal infections and discharge
- menstrual pain
- breast pain or discomfort
- expulsion of the IUS
This list above includes the more common side effects of your medicine.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
- signs of allergy such as rash, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing
- excessive pain or bleeding, which may indicate perforation of the womb
- fever, chills or generally feeling unwell
You may need urgent medical attention or hospitalisation if you experience the above side effects. These side effects are rare.
Cases of allergic reactions such as rash, hives and swelling have been reported with the use of IUSs.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
STORAGE
Keep it where children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.
Store Kyleena in a cool dry place where the temperature stays below 30°C. Do not leave it in the car.
Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.
Do not open the package before giving it to the doctor.
PRODUCT DESCRIPTION
What it looks like
Kyleena is a small, white coloured T-shaped plastic system. Two blue removal threads are attached to the lower end of the vertical arm. The vertical stem contains a silver ring located close to the horizontal arms, which is visible under ultrasound examination.
The T-shaped frame also contains barium sulfate so that it can be seen on X-rays.
Kyleena is contained within an insertion device and is provided in a sterile package for insertion by a doctor experienced in the insertion of IUSs.
Ingredients
Active ingredient:
- Kyleena – 19.5 mg of levonorgestrel per IUS
Inactive ingredients:
- dimethylsiloxane/methylviny lsiloxane cross linked elastomer
- colloidal anhydrous silica
- polyethylene
- polypropylene
- barium sulfate
- pigment blue 15
- silver
Supplier
Made in Finland for:
Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073
Australian Registration Number
Kyleena – AUST R 270517
Date of preparation
March 2021
See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.
® Registered trademark of the Bayer Group, Germany
© Bayer Australia Ltd
All rights reserved.
Published by MIMS May 2021
