Drugs List

Therapeutic Indications

Uses

Intra-uterine contraception - progestogen only

Not recommended as first line contraception in nulliparous women.

Contraindications

Cervicitis
Postpartum endometritis
Uterine cancer
Within 3 months of infected abortion
Acute hepatic disorder
Acute pelvic inflammatory disease
Cervical cancer
Cervical dysplasia
Congenital abnormality of the uterus
Female genital infection
Hepatic neoplasm
Hormone dependent neoplasm
Pregnancy
Recurrent pelvic inflammatory disease
Undiagnosed gynaecological haemorrhage
Uterine fibroids
Vaginitis

Precautions and Warnings

History of ectopic pregnancy
Severe headache
Breastfeeding
History of symptomatic functional ovarian cysts
History of uterine surgery
Jaundice
Migraine
Porphyria
Severe arterial disorder
Severe hypertension

May decrease glucose tolerance in patients with diabetes mellitus
Exclude cervical infection before treatment
Exclude endometrial abnormalities before treatment
Exclude sexually transmitted disease before treatment
Exclude perforation in cases of difficult insertion
Expulsion may occur if inserted incorrectly
Remove/replace intrauterine system by the end of the third year
Treatment to be administered by or under supervision of specialist
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
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
Irregular bleeding may mask signs of endometrial cancer
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with functional ovarian cysts/delayed follicular atresia
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 if first appearance of migraine or severe or frequent headache
Discontinue if significant rise in blood pressure occurs
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

It is recommended that this intrauterine system should only be inserted by healthcare professionals who are experienced in interuterine system (IUS) insertions and/or who have undergone specific training on the levonorgestrel 13.5mg intrauterine system.

Uterine perforation may occur with insertion of an intrauterine device or system. Important risk factors associated with uterine perforation are insertion during breastfeeding, insertion in the 36 weeks after giving birth and in women with fixed retroverted uterus. (See counselling for symptoms of perforation). 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 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.

Before insertion a physical examination must be completed including a pelvic and breast examination and a cervical smear.

Pelvic infections may occur following insertion of levonorgestrel 13.5mg intrauterine system. Before use, evaluate patients risk factors for pelvic infection (e.g. multiple sexual parters, sexually transmitted infections, prior history of pelvic inflammatory disease) and screen for pre-existing genital infections where appropriate. All infections must be treated prior to insertion. Rarely severe infection or sepsis has occurred. Bacterial examinations are indicated and monitoring is recommended, even with discrete symptoms indicative of infections.

Adverse effects reported during the insertion and removal procedure include vasovagal episodes and precipitation of a seizure in an epileptic patient.

Levonorgestrel intrauterine system 13.5mg can be distinguished from other IUSs by the visibility of the silver ring on ultrasound and the brown colour removal threads. The T-frame contains barium sulphate which makes it visible in X-ray examination.

Ectopic pregnancy has occurred with levonorgestrel 13.5mg intrauterine system. Women with a history of ectopic pregnancy, tubal surgery or pelvic infection have an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy would be considered in the case of lower abdominal pain, especially in connection with missed periods or if amenorrhoeic women start bleeding.

Levonorgestrel 13.5mg intrauterine system affects menstrual bleeding due to its mode of action. In the first few months irregular bleeding and spotting may occur, followed by a reduction in the duration and volume of menstrual bleeding. This may develop into oligomenorrhoea or amenorrhoea. Pregnancy should be considered if menstruation does not occur within 6 weeks after the onset of previous menstruation. A repeated pregnancy test is not necessary in subjects who remain amenorrhoeic unless indicated by other signs of pregnancy.

If bleeding becomes heavier and/or more irregular after time, appropriate diagnostic measures should be taken as irregular bleeding may be a symptom of endometrial polyps, hyperplasia or cancer and heavy bleeding may be a sign of unnoticed expulsion of IUS.

Pregnancy and Lactation

Pregnancy

Levonorgestrel intrauterine system is contraindicated in pregnancy.

If a women becomes pregnant while using the system ectopic pregnancy should be excluded. Timely removal of the system is recommended since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour.

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 ).

Lactation

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.

Breastfeeding increases the risk of uterine perforation on insertion.

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

Side Effects

"Spotting" bleeding
Abdominal pain
Acne
Alopecia
Amenorrhoea
Angioedema
Breast pain
Breast tenderness
Delayed follicular atresia
Depression
Dizziness
Dysmenorrhoea
Epileptic seizure on insertion
Genital infections
Headache
Hirsutism
Hypersensitivity reactions
Increased risk of ectopic pregnancy
Irregular uterine bleeding
Menstrual bleeding decreased
Menstrual bleeding increased
Menstrual disturbances
Migraine
Mood changes
Nausea
Oligomenorrhoea
Ovarian cysts
Pain or bleeding on insertion
Pelvic pain
Prolonged bleeding
Rash
Reduced libido
Seborrhoea
Sepsis
Syncope
Urticaria
Uterine perforation
Vaginal discharge
Vaginitis
Vasovagal attack on insertion
Weight gain

Presentation

Intrauterine system containing 13.5mg levonorgestrel.

Drugs List

Therapeutic Indications

Uses

Intra-uterine contraception - progestogen only

Not recommended as first line contraception in nulliparous women.

Dosage

Adults

Contraindications

Cervicitis
Postpartum endometritis
Uterine cancer
Within 3 months of infected abortion
Acute hepatic disorder
Acute pelvic inflammatory disease
Cervical cancer
Cervical dysplasia
Congenital abnormality of the uterus
Female genital infection
Hepatic neoplasm
Hormone dependent neoplasm
Pregnancy
Recurrent pelvic inflammatory disease
Undiagnosed gynaecological haemorrhage
Uterine fibroids
Vaginitis

Precautions and Warnings

History of ectopic pregnancy
Severe headache
Breastfeeding
History of symptomatic functional ovarian cysts
History of uterine surgery
Jaundice
Migraine
Porphyria
Severe arterial disorder
Severe hypertension

May decrease glucose tolerance in patients with diabetes mellitus
Exclude cervical infection before treatment
Exclude endometrial abnormalities before treatment
Exclude sexually transmitted disease before treatment
Exclude perforation in cases of difficult insertion
Expulsion may occur if inserted incorrectly
Remove/replace intrauterine system by the end of the third year
Treatment to be administered by or under supervision of specialist
Do breast & pelvic exam. before & during treatment if clinically indicated
Exclude pregnancy prior to initiation of treatment
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
Irregular bleeding may mask signs of endometrial cancer
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients with functional ovarian cysts/delayed follicular atresia
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 if first appearance of migraine or severe or frequent headache
Discontinue if significant rise in blood pressure occurs
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

It is recommended that this intrauterine system should only be inserted by healthcare professionals who are experienced in interuterine system (IUS) insertions and/or who have undergone specific training on the levonorgestrel 13.5mg intrauterine system.

Uterine perforation may occur with insertion of an intrauterine device or system. Important risk factors associated with uterine perforation are insertion during breastfeeding, insertion in the 36 weeks after giving birth and in women with fixed retroverted uterus. (See counselling for symptoms of perforation). 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 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.

Before insertion a physical examination must be completed including a pelvic and breast examination and a cervical smear.

Pelvic infections may occur following insertion of levonorgestrel 13.5mg intrauterine system. Before use, evaluate patients risk factors for pelvic infection (e.g. multiple sexual parters, sexually transmitted infections, prior history of pelvic inflammatory disease) and screen for pre-existing genital infections where appropriate. All infections must be treated prior to insertion. Rarely severe infection or sepsis has occurred. Bacterial examinations are indicated and monitoring is recommended, even with discrete symptoms indicative of infections.

Adverse effects reported during the insertion and removal procedure include vasovagal episodes and precipitation of a seizure in an epileptic patient.

Levonorgestrel intrauterine system 13.5mg can be distinguished from other IUSs by the visibility of the silver ring on ultrasound and the brown colour removal threads. The T-frame contains barium sulphate which makes it visible in X-ray examination.

Ectopic pregnancy has occurred with levonorgestrel 13.5mg intrauterine system. Women with a history of ectopic pregnancy, tubal surgery or pelvic infection have an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy would be considered in the case of lower abdominal pain, especially in connection with missed periods or if amenorrhoeic women start bleeding.

Levonorgestrel 13.5mg intrauterine system affects menstrual bleeding due to its mode of action. In the first few months irregular bleeding and spotting may occur, followed by a reduction in the duration and volume of menstrual bleeding. This may develop into oligomenorrhoea or amenorrhoea. Pregnancy should be considered if menstruation does not occur within 6 weeks after the onset of previous menstruation. A repeated pregnancy test is not necessary in subjects who remain amenorrhoeic unless indicated by other signs of pregnancy.

If bleeding becomes heavier and/or more irregular after time, appropriate diagnostic measures should be taken as irregular bleeding may be a symptom of endometrial polyps, hyperplasia or cancer and heavy bleeding may be a sign of unnoticed expulsion of IUS.

Pregnancy and Lactation

Pregnancy

Levonorgestrel intrauterine system is contraindicated in pregnancy.

If a women becomes pregnant while using the system ectopic pregnancy should be excluded. Timely removal of the system is recommended since any intrauterine contraceptive left in situ may increase the risk of abortion and preterm labour.

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 ).

Lactation

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.

Breastfeeding increases the risk of uterine perforation on insertion.

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

Counselling

Advise the patient of potential side effects and risks associated with therapy.

Advise patient to report any abnormal or irregular bleeding, abdominal or pelvic pain.

Advise patient to report signs of uterine perforation. Symptoms include severe pelvic pain after insertion (worse than period cramps), pain or heavy bleeding after insertion which continues for more a few weeks, sudden changes in period, pain during sex, not being able to feel the threads.

Advise patient partial or complete expulsion can occur without symptoms. Advise patient how to check removal threads and to contact their healthcare provider if they cannot be felt.

Advise patient about signs, symptoms and risks of ectopic pregnancy. Advise patient an ectopic pregnancy may impact future fertility.

Advise patient that the removal threads may be felt by their partner during intercourse.

Side Effects

"Spotting" bleeding
Abdominal pain
Acne
Alopecia
Amenorrhoea
Angioedema
Breast pain
Breast tenderness
Delayed follicular atresia
Depression
Dizziness
Dysmenorrhoea
Epileptic seizure on insertion
Genital infections
Headache
Hirsutism
Hypersensitivity reactions
Increased risk of ectopic pregnancy
Irregular uterine bleeding
Menstrual bleeding decreased
Menstrual bleeding increased
Menstrual disturbances
Migraine
Mood changes
Nausea
Oligomenorrhoea
Ovarian cysts
Pain or bleeding on insertion
Pelvic pain
Prolonged bleeding
Rash
Reduced libido
Seborrhoea
Sepsis
Syncope
Urticaria
Uterine perforation
Vaginal discharge
Vaginitis
Vasovagal attack on insertion
Weight gain

Overdosage

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 ).

Further Information

Last Full Review Date: May 2018

Reference Sources

Summary of Product Characteristics: Jaydess 13.5 mg intrauterine delivery system. Bayer plc. Revised June 2020.

MHRA Drug Safety Update June 2015
Available at: https://www.mhra.gov.uk
Last accessed: 02 May 2018

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 May 2018

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 17 November 2017
Last accessed: 03 May 2018