Frequently Asked Questions

Kyleena® (19.5mg intrauterine delivery system levonorgestrel) is an intrauterine system (IUS) indicated as a contraceptive for the prevention of pregnancy for up to 5 years.​

Of the IUS with a 5 or 8 year contraception license, Kyleena® has the smallest T frame (28 x 30 mm) and narrowest insertion tube (3.8 mm).

In a multicentre study, a survey showed that 48% of women aged 18-44, and in particular young women (18-24 - 57%) forgot to take their contraceptive pill in the last 3 months. Kyleena® can be beneficial for women who struggle to adhere to contraceptive compliance, e.g. taking the pill at the same time every day.

In the same survey, 87% of women mentioned that a method not requiring daily, weekly or monthly dosing would make things easier and 80% would consider switching contraceptives to minimise oestrogen exposure.

• Kyleena® contains 19.5 mg levonorgestrel and has a mainly local progestogenic effect in the uterine cavity.

Interactions can occur with medicinal products that induce microsomal enzymes, which can result in increased clearance of sex hormones, for example:

• Medicines used to treat epilepsy (e.g. phenytoin and topiramate)​

• Sedatives (called barbiturates)​

• Anticonvulsants (e.g. primidone and carbamazepine)​

• Certain antibiotics (e.g. rifampicin and possibly also oxcarbazepine)​

• Antifungal medicines (e.g. griseofulvin)​

• Products containing St John's wort (a herbal remedy)​

It is advised that prescribing information of concomitant medications should be consulted to identify potential interactions. For a full list of medicinal interactions and contraindications, refer to the Summary of Product Characteristics.

The majority of patients experience changes in menstrual bleeding pattern after insertion of Kyleena® (19.5 mg intrauterine delivery system levonorgestrel). Women can experience shorter, lighter bleeds and can experience amenorrhoea over 5 years. Very common side effects (more than 1 in 10 women) include:

• headache​

• abdominal/pelvic pain​

• acne/greasy skin​

• bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods and absence of bleeding​

• ovarian cysts​

• inflammation of the external genital organs and vagina (vulvovaginitis)​

• Common side effects (up to 1 in 10 women) include:​

• depressed mood/depression​

• migraine​

• feeling sick (nausea)​

• upper genital tract infection​

• painful menstruation​

• breast pain/discomfort​

• device expulsion (complete and partial)​

• hair loss​

• genital discharge​

For a full list of potential side effects, refer to the Summary of Product Characteristics and Patient Information Leaflet. Educational Risk Minimisation Materials can be downloaded here to help reduce the risks associated with using Kyleena®.

If the patient does experience side effects, they should speak to a doctor, pharmacist or nurse. This includes any possible side effects not listed in the contraception package leaflet.

Weight gain has been reported as common (can occur in less than 1 in 10 women) in women fitted with Kyleena (19.5mg intrauterine delivery system levonorgestrel)

For Mirena® (52 mg intrauterine delivery system levonorgestrel), very common undesirable effects (occurring in more than 10% of users) include uterine/vaginal bleeding, such as spotting, oligomenorrhoea and amenorrhoea. Undesirable effects are more common during the first months after the insertion and subside during prolonged use.​

For Kyleena® (19.5 mg intrauterine delivery system levonorgestrel), very common undesirable effects include headaches, abdominal/pelvic pain, acne/seborrhoea, ovarian cysts, vulvovaginitis and bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent bleeding and amenorrhoea. Over time, the frequency of amenorrhoea and infrequent bleeding increases, and the frequency of prolonged, irregular and frequent bleeding decreases.​

For further information on Kyleena® and Mirena® please visit the Summary of Product Characteristics.

Effects on the menstrual bleeding pattern are expected in most users of Kyleena®.​

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.​

Patients may have bleeding and spotting between menstrual periods, especially during the first months.​

Overall, patients are likely to have a gradual reduction in the amount and number of days of bleeding each month. Some women eventually find that periods stop altogether, with 23% experiencing amenorrhoea at the end of Year 5.​

When the intrauterine system (IUS) is removed, the patient’s menstrual cycle should return to normal.

Both Mirena® and Kyleena® affect patients’ bleeding patterns.

A phase II, randomised, open-label study in 738 women compared the IUSs Jaydess®▼ (13.5mg intrauterine delivery system levonorgestel), Kyleena® and Mirena® (with initial in vitro release rates of 12 μg/d, 16 μg/d and 20 μg/d respectively) and found that the bleeding profiles were similar in all groups, although total bleeding and spotting days decreased with increasing levonorgestrel dose.

The contraceptive efficacy of Kyleena® (19.5 mg intrauterine delivery system levonorgestrel) has been evaluated in a clinical study with 1,452 women aged 18–35 including 39.5% (574) nulliparous women of whom 84.0% (482) were nulligravid using Kyleena®. The 1-year Pearl Index was 0.16 (95% confidence interval 0.02–0.58) and the 5-years Pearl Index was 0.29 (95% confidence interval 0.16–0.50). The failure rate was approximately 0.2% at Year 1 and the cumulative failure rate was approximately 1.4% at Year 5.

It is therefore, uncommon for a patient to become pregnant while using Kyleena®, however, approximately half of the pregnancies that occur during Kyleena®-use are likely to be ectopic.

The overall incidence of ectopic pregnancy in Phase II and III clinical trials with Kyleena® was 0.2 per 100  women-years.

The possibility of an ectopic pregnancy must be carefully considered and evaluated. An 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.

The use of a levonorgestrel-releasing intrauterine delivery system does not alter the course of future fertility. Upon removal of the intrauterine system, women return to their normal fertility.

It is uncommon for a woman to become pregnant while using Kyleena®, however, approximately half of the pregnancies that occur during Kyleena®-use are likely to be ectopic. If a patient does become pregnant while using Kyleena®, ectopic pregnancy should be excluded and timely removal of the system is recommended, since any intrauterine contraceptive left in situ may increase the risk of miscarriage and preterm labour.​

Women considering Kyleena® should be counselled on the signs, symptoms and risks of ectopic pregnancy on an individual basis as an ectopic pregnancy may impact future fertility. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk of ectopic pregnancy. If the patient 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 of the infant. The course of such a pregnancy should be closely monitored. The patient should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever.​

For more information and a complete list of contraindications, refer to the Kyleena® Summary of Product Characteristics

Kyleena® (19.5 mg intrauterine delivery system levonorgestrel), has a small T-frame (28 x 30 mm) placed using an inserter with narrow insertion tube (3.8 mm).​

Kyleena® may be suitable for women who would prefer a lower dose of levonorgestrel and do not require the added endometrial protection during oestrogen replacement therapy or treatment for menorrhagia. For an intrauterine delivery system that is licensed for these indications, refer to information on Mirena® (52 mg intrauterine delivery system levonorgestrel).

Kyleena® and Jaydess®▼ (13.5 mg intrauterine delivery system levonorgestrel) are smaller (28 x 30 mm) than Mirena® (32 x 32 mm). 

The IUS, Jaydess®▼, contains 13.5 mg levonorgestrel, Kyleena®, contains 19.5 mg levonorgestrel, a lower dose than Mirena®, containing 52 mg levonorgestrel.

Kyleena® is indicated as contraception for up to 5 years, compared with Jaydess®▼, which is effective for 3 years.

For more information about Bayer IUS please visit the Risk Minimisation Materials

If the patient wishes to continue using the same method, a new system can be inserted at the same time (removal should be carried out within 7 days of the onset of menstruation), in which case no additional protection is required provided the woman is experiencing regular menses.