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KYLEENA is a brand name for Levonorgestrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Contraception for up to 5 years.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Kyleena is inserted into the uterine cavity and is effective for up to 5 years. Insertion It is recommended that Kyleena should only be inserted by healthcare professionals who are experienced in IUS insertions and/ or have undergone training on the Kyleena insertion procedure.
Before insertion, the patient should have been carefully examined in order to detect any contraindication to IUS insertion. Exclude pregnancy before insertion. Consider the possibility of ovulation and conception before using this product.
4 under Medical examination/consultation).
Table 1:
When to insert Kyleena in women of fertile age Starting Kyleena - Kyleena should be inserted into the uterine cavity within 7 days of the onset of menstruation. In this case Kyleena provides contraceptive protection upon insertion and no back-up contraception is needed.
- If insertion within 7 days of the onset of menstruation is not possible or the woman does not experience regular menses, Kyleena may be inserted at any time during the menstrual cycle provided that the healthcare professional can reliably exclude the possibility of prior conception.
However, in this case immediate contraceptive protection upon insertion is not reliably ensured. Therefore, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for the next 7 days to prevent pregnancy.
Postpartum insertion In addition to the instructions above (Starting Kyleena):
Postpartum insertions should be postponed until the uterus is fully involuted, however should not be performed earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. Insertion after first trimester abortion Kyleena can be inserted immediately after first trimester abortion.
In this case no back-up contraception is needed. Replacing Kyleena Kyleena can be replaced by a new system at any time in the menstrual cycle. In this case no back up contraception is needed. , combined hormonal contraceptives, implant) - Kyleena can be inserted immediately if it is reasonably certain that the woman is not pregnant.
- Need for back-up contraception: If it has been more than 7 days since menstrual bleeding began, the woman should abstain from vaginal intercourse or use additional contraceptive protection for the next 7 days. Important information to consider during or after insertion In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, the possibility of perforation should be considered and appropriate steps should be taken, such as physical examination and ultrasound.
Summary of the safety profile The majority of women experience changes in menstrual bleeding pattern after insertion of Kyleena. Over time, the frequency of amenorrhoea and infrequent bleeding increases, and the frequency of prolonged, irregular and frequent bleeding decreases.
The following bleeding patterns were observed in clinical trials:
Table 3: Bleeding patterns reported with Kyleena in clinical trials Kyleena First 90 days Second 90 days End of year 1 End of year 3 End of year 5 Amenorrhoea < 1% 5% 12% 20% 23% Infrequent bleeding 10% 20% 26% 26% 26% Frequent bleeding 25% 10% 4% 2% 2% Prolonged bleeding* 57% 14% 6% 2% 1% Irregular bleeding 43% 25% 17% 10% 9% *Subjects with prolonged bleeding may also be included in one of the other categories (excluding amenorrhoea) Tabulated summary of adverse events The frequencies of Adverse Drug Reactions (ADRs) reported with Kyleena are summarized in the table below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
System Organ Class Very Common Common Uncommon Psychiatric disorders Depressed mood/Depression Decreased libido Nervous system disorders Headache Migraine Vascular disorders Dizziness Gastrointestinal disorders Abdominal/pelvic pain Nausea Skin and subcutaneous tissue disorders Acne/Seborrhoea Alopecia Hirsutism Reproductive system and breast disorders Bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent bleeding and amenorrhoea Ovarian cyst* Vulvovaginitis Upper genital tract infection Dysmenorrhoea Breast pain/discomfort Device expulsion (complete and partial) Genital discharge Uterine perforation** Investigations Increased weight * In clinical trials ovarian cysts had to be reported as AEs if they were abnormal, non- functional cysts and/or had a diameter > 3 cm on ultrasound examination.
Figure 8 Kyleena 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 Kyleena, including the signs and symptoms of perforation and the risk of ectopic pregnancy, see below.
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 of Kyleena is important in order to maximize the efficacy and reduce the risk of expulsion.
The instructions for the insertion should be followed carefully. Emphasis should be given to training in the correct insertion technique. Insertion and removal may be associated with some pain and bleeding. 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.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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After insertion, women should be re-examined after 4 to 6 weeks to check the threads and ensure that the device is in the correct position. 4). Kyleena can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the blue colour of the removal threads.
The T-frame of Kyleena contains barium sulfate which makes it visible in X-ray examination. Removal/replacement Kyleena is removed by gently pulling on the threads with forceps. The use of excessive force/sharp instruments during removal may cause breakage of the system.
After removal of Kyleena, the system should be examined to ensure that it is intact and has been completely removed. If the threads are not visible determine the location of the system via ultrasound or other method. If the system is in the uterine cavity , it may be removed using narrow forceps.
This may require dilatation of the cervical canal or other surgical intervention. The system should be removed no later than by the end of the fifth year. Continuation of contraception after removal • If the woman wishes to continue using the same method, a new system can be inserted immediately following removal of the original system.
• If the woman does not wish to continue using the same method but pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation, provided the woman is experiencing regular menses. If the system is removed at some other time during the cycle or the woman does not experience regular menses and the woman has had intercourse within a week, she is at risk of pregnancy.
To ensure continuous contraception a barrier contraceptive method should be used (such as condoms) starting at least 7 days before the removal. After removal, the new contraceptive method should be started immediately (follow the instructions for use of the new contraceptive method).
Elderly Kyleena is not indicated for use in postmenopausal women. Hepatic impairment Kyleena has not been studied in women with hepatic impairment. 3). Renal impairment Kyleena has not been studied in women with renal impairment. Paediatric population Use of this product before menarche is not indicated.
1. Method of administration To be inserted by a healthcare professional using aseptic technique. Kyleena is supplied in a sterile package within an integrated inserter that enables single handed loading. The package should not be opened until needed for insertion.
Do not resterilize. As supplied, Kyleena is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date which is stated on the carton and the blister after EXP. Any unused product or waste material should be disposed of in accordance with local requirements.
Kyleena is supplied with a patient reminder card in the outer carton. Complete the patient reminder card and give […]
4 under Perforation). In clinical trials with Kyleena that excluded breastfeeding women the frequency of perforation was "rare". Description of selected adverse reactions With the use of levonorgestrel-IUS, cases of hypersensitivity including rash, urticaria and angioedema have been reported.
4 under Ectopic Pregnancy). The removal threads may be felt by the partner during intercourse. The following ADRs have been reported in connection with the insertion or removal procedure of Kyleena: Procedural pain, procedural bleeding, insertion-related vasovagal reaction with dizziness or syncope.
The procedure may precipitate a seizure in an epileptic patient. 4 under Pelvic Infection). Paediatric population The safety profile of Kyleena is expected to be the same for adolescents under the age of 18 as for users 18 years and older.
1. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.
For long-acting products like Kyleena, please report information of when Kyleena was inserted and removed, as applicable.
In case Kyleena cannot be located in the uterine cavity, expulsion or complete perforation should be considered (see paragraph “perforation” below) and X-ray may be used. Thereafter, re-examination should be performed once a year or more frequently if clinically indicated.
Kyleena is not for use as a post-coital contraceptive. The use of Kyleena 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 Kyleena.
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. 6) per 1000 insertions in the copper IUD cohort. The study showed that both breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation (see Table 2).
Both risk factors were independent of the type of IUD inserted. 5) per 1000 insertions. Breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were confirmed as risk factors also in the subgroup that were followed up for 5 years.
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. Breast cancer A meta-analysis from 54 epidemiological studies reported that there is a slightly […]