BNF for Children (BNFC) 2018-2019

JAYDESS®13.5MG INTRA-UTERINE DEVICE

Contraception
▶BY VAGINA
▶Females of childbearing potential:Insert into uterine
cavity within 7 days of onset of menstruation, or any
time if replacement, or immediately afterfirst-
trimester termination; postpartum insertions should
be delayed until at least 6 weeks after delivery
( 12 weeks if uterus involution is substantially delayed);
effective for 3 years

KYLEENA®19.5MG INTRA-UTERINE DEVICE

Contraception
▶BY INTRA-UTERINE ADMINISTRATION
▶Females of childbearing potential:Insert into uterine
cavity within 7 days of onset of menstruation, or any
time if replacement, or immediately afterfirst-
trimester termination; postpartum insertions should
be delayed until at least 6 weeks after delivery and not
before uterus is fully involuted; effective for 5 years

LEVOSERT®20MICROGRAMS/24HOURS INTRA-UTERINE
DEVICE

Contraception|Menorrhagia
▶BY INTRA-UTERINE ADMINISTRATION
▶Females of childbearing potential:Insert into uterine
cavity within 7 days of onset of menstruation, or any
time if replacement, or immediately afterfirst-
trimester abortion; postpartum insertions should be
delayed until at least 6 weeks after delivery and not
before uterus is fully involuted; effective for 4 years

MIRENA®20MICROGRAMS/24HOURS INTRA-UTERINE DEVICE

Contraception|Menorrhagia
▶BY INTRA-UTERINE ADMINISTRATION
▶Females of childbearing potential:Insert into uterine
cavity within 7 days of onset of menstruation, or any
time if replacement, or any time if reasonably certain
woman is not pregnant and there is no risk of
conception (additional precautions (e.g. barrier
methods) necessary for next 7 days), or immediately
afterfirst-trimester termination by curettage;
postpartum insertions should be delayed until at least
4 weeks after delivery; effective for 5 years

Prevention of endometrial hyperplasia during oestrogen
replacement therapy
▶BY INTRA-UTERINE ADMINISTRATION
▶Females of childbearing potential:Insert during last days
of menstruation or withdrawal bleeding or at any time
if amenorrhoeic; effective for 4 years

DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶When used orally as an emergency contraceptive, the
effectiveness of levonorgestrel is reduced in women
taking enzyme-inducing drugs (and for up to 4 weeks
after stopping); a copper intra-uterine device should
preferably be used instead. If the copper intra-uterine
device is undesirable or inappropriate, the dose of
levonorgestrel should be increased to a total of 3 mg
taken as a single dose; pregnancy should be excluded
following use, and medical advice sought if pregnancy
occurs.
▶There is no need to increase the dose for emergency
contraception if the patient is taking antibacterials that
are not enzyme inducers.
▶With the progestogen-only intra-uterine device,
levonorgestrel is released close to the site of the main
contraceptive action (on cervical mucus and
endometrium) and therefore progestogenic side-effects
and interactions are less likely; in particular, enzyme-
inducing drugs are unlikely to significantly reduce the
contraceptive effect of the progestogen-only intra-
uterine system and additional contraceptive
precautions are not required.

lUNLICENSED USEgDose for emergency contraception

in patients with body-weight over 70 kg or BMI over

26 kg/m^2 differs from product licence. Use for emergency

contraception between^72 –^96 hours after coitus differs

from product licence.h

▶With oral useConsult product literature for licensing status

of individual preparations.

▶With vaginal useNot licensed for use in women under

18 years.

IMPORTANT SAFETY INFORMATION

MHRA/CHM ADVICE (JUNE 2015) INTRA-UTERINE

CONTRACEPTION: UTERINE PERFORATION—UPDATED

INFORMATION ON RISK FACTORS

Uterine perforation most often occurs during insertion,

but might not be detected until sometime later. The risk

of uterine perforation is increased when the device is

inserted up to 36 weeks postpartum or in patients who

are breastfeeding. Before inserting an intra-uterine

contraceptive device, inform patients that perforation

occurs in approximately 1 in every 1000 insertions and

signs and symptoms include:

.severe pelvic pain after insertion (worse than period

cramps);

.pain or increased bleeding after insertion which

continues for more than a few weeks;

.sudden changes in periods;

.pain during intercourse;

.unable to feel the threads.

Patients should be informed on how to check their

threads and to arrange a check-up if threads cannot be

felt, especially if they also have significant pain. Partial

perforation may occur even if the threads can be seen;

consider this if there is severe pain following insertion

and perform an ultrasound.

lCONTRA-INDICATIONS

▶With intra-uterine useActive trophoblastic disease (until

return to normal of urine- and plasma-gonadotrophin

concentration.acute cervicitis.acute malignancies

affecting the blood (use with caution in remission).acute

vaginitis.distorted uterine cavity.history of breast cancer

but can be considered for a woman in long-term remission

who has menorrhagia and requires effective contraception

.increased risk factors for pelvic infections.infected

abortion during the previous three months.not suitable

for emergency contraception.pelvic inflammatory disease

.postpartum endometritis.unexplained uterine bleeding.

unresolved cervical intraepithelial neoplasia.uterine or

cervical malignancy

▶With oral useAcute porphyrias p. 603

▶With oral use for contraceptionHistory of breast cancer but

can be used after 5 years if no evidence of disease and non-

hormonal contraceptive methods unacceptable.severe

arterial disease.undiagnosed vaginal bleeding

lCAUTIONS

GENERAL CAUTIONSRisk factors for ectopic pregnancy

(including previous ectopic pregnancy, tubal surgery or

pelvic infection)

SPECIFIC CAUTIONS

▶With intra-uterine useDisease-induced immunosuppression

(risk of infection—avoid if marked immunosuppression).

acute venous thromboembolism (consider removal).

anaemia.anticoagulant therapy (avoid if possible).

diabetes.drug-induced immunosuppression (risk of

infection—avoid if marked immunosuppression).

endometriosis.epilepsy (risk of seizure at time of

insertion).fertility problems.history of pelvic

inflammatory disease.increased risk of expulsion if

inserted before uterine involution.jaundice (consider

removal).marked increase of blood pressure (consider

removal).menorrhagia (progestogen intra-uterine system

BNFC 2018 – 2019 Contraception, oral progestogen-only 509

Genito-urinary system

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