Levonorgestrel intrauterine 19.5mg
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Intrauterine system containing 19.5mg levonorgestrel.
Intra-uterine contraception - progestogen only
The device will be effective for up to 5 years after which the device may be removed and if the women wishes to continue using the same method immediately replaced with a new system.
Levonorgestrel intrauterine 19.5mg system may be inserted into the uterine cavity at one of the following times:
Within 7 days of the onset of menstruation.
Immediately after first trimester termination.
Can be replaced by a new system at any time in the cycle.
Postpartum insertions should be postponed until the uterus is fully involuted, however not earlier than six weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum.
If pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation, provided the woman is still experiencing regular menses. If the system is removed at some other time during the cycle or the women does not experience regular menses and the woman had has intercourse within a week, she is at risk of pregnancy. To ensure continuous contraception a new system should be immediately inserted or an alternative contraceptive method should have been initiated.
Within 3 months of infected abortion
Acute hepatic disorder
Acute pelvic inflammatory disease
Congenital abnormality of the uterus
Female genital infection
Recent trophoblastic disorder
Recurrent pelvic inflammatory disease
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
History of ectopic pregnancy
History of pelvic inflammatory disease
History of symptomatic functional ovarian cysts
Severe arterial disorder
May decrease glucose tolerance in patients with diabetes mellitus
Assess family medical history prior to commencing treatment
Exclude cervical infection before treatment
Exclude endometrial abnormalities before treatment
Exclude sexually transmitted disease before treatment
Treatment to be prescribed under the supervision of a specialist
Aseptic technique should be used throughout
Exclude perforation in cases of difficult insertion
Expulsion may occur if inserted incorrectly
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
Perform a complete physical and gynaecological examination before therapy
Abnormal and/or irregular bleeding should be investigated
Examine patient six weeks after insertion
Exclude pregnancy if retrieval threads are not visible at cervix
If pregnancy occurs possibility of ectopic pregnancy should be considered
Monitor blood glucose closely in patients with diabetes mellitus
Advise patient of potential side effects and risks associated with therapy
Consider ectopic pregnancy if abdominal and menstrual disturbances occur
Discontinue at first signs of jaundice
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if first appearance of migraine or severe or frequent headache
Discontinue if significant rise in blood pressure occurs
Discontinue if symptoms due to endometriosis are exacerbated
Remove if partial expulsion-cervical/uterine perforation-intractable pain
Remove if pelvic inflammatory disease resistant to treatment
Female: Not suitable for use as post-coital contraception
Advise patient to report signs of uterine perforation
Changes in menstrual bleeding patterns should be expected
Give patient package leaflet and patient reminder card
Treatment does not protect against risk of sexually transmitted disease
Uterine perforation may occur with insertion of an intrauterine device or system. The most important risk factors associated uterine perforation are insertion during breastfeeding and insertion in the 36 weeks after giving birth. Consider partial perforation if severe pain occurs after insertion, even if the threads are visible.
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. Physical examination alone may not be sufficient to exclude partial perforation, which may have occurred even if the threads are still visible. Levonorgestrel intrauterine system 19.5 mg can be distinguished from other IUSs by the visibility of the silver ring on ultrasound and the blue colour of the removal threads. The T-frame contains barium sulphate which makes it visible in X-ray examination.
Pregnancy and Lactation
Levonorgestrel intrauterine system is contraindicated in pregnancy.
If a women becomes pregnant while using the system 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 abortion and preterm labour.
Removal of the system or probing of the uterus may result in spontaneous abortion. If the women 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.
Because of the intrauterine administration and the local exposure to levonorgestrel, the possible occurrence of virilizing effects in a female foetus should be taken into consideration. Clinical experience of the outcomes of pregnancies under levonorgestrel treatment is limited due to the high contraceptive efficacy. Women should be informed that, to date, there is no evidence of birth defects caused by a levonorgestrel-releasing intrauterine system use in cases where pregnancy has continued to term with the system in place.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Levonorgestrel intrauterine system is considered safe for use in breastfeeding.
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.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Pain or bleeding on insertion
Vasovagal attack on insertion
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: February 2018
Summary of Product Characteristics: Kyleena 19.5 mg intrauterine delivery system. Bayer plc. Revised June 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 February 2018
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