might be preferable).migraine (consider removal).
nulliparity.severe arterial disease (consider removal).
severe cervical stenosis.severe headache (consider
removal).severe primary dysmenorrhoea.severely scarred
uterus (including after endometrial resection).young age
▶With oral use for contraceptionActive trophoblastic disease
(until return to normal of urine- and plasma-
gonadotrophin concentration)—seek specialist advice.
arterial disease.functional ovarian cysts.history of
jaundice in pregnancy.malabsorption syndromes.past
ectopic pregnancy.sex-steroid dependent cancer.
systemic lupus erythematosus with positive (or unknown)
antiphospholipid antibodies
▶With oral use for emergency contraceptionActive trophoblastic
disease (until return to normal of urine- and plasma-
gonadotrophin concentration)—seek specialist advice.
past ectopic pregnancy.severe malabsorption syndromes
CAUTIONS, FURTHER INFORMATION
An intra-uterine device should not be removed in mid-
cycle unless an additional contraceptive was used for the
previous 7 days. If removal is essential post-coital
contraception should be considered.
▶Risk of infection with intra-uterine devicesThe main excess risk
of infection occurs in thefirst 20 days after insertion and is
believed to be related to existing carriage of a sexually
transmitted infection. Women are considered to be at a
higher risk of sexually transmitted infections if:
.they are under 25 years oldor
.they are over 25 years oldand
.have a new partneror
.have had more than one partner in the past yearor
.their regular partner has other partners.
In these women, pre-insertion screening (for chlamydia
and, depending on sexual history and local prevalence of
disease,Neisseria gonorrhoeae) should be performed. If
results are unavailable at the time offitting an intra-
uterine device for emergency contraception, appropriate
prophylactic antibacterial cover should be given. The
woman should be advised to attendas an emergencyif she
experiences sustained pain during the next 20 days.
▶Use as a contraceptive in co-morbidities
▶With oral useThe product literature advises caution in
patients with history of thromboembolism, hypertension,
diabetes mellitus and migraine; evidence for caution in
these conditions is unsatisfactory.
MIRENA®20MICROGRAMS/24HOURS INTRA-UTERINE
DEVICEAdvanced uterine atrophy
lINTERACTIONS→Appendix 1 : levonorgestrel
lSIDE-EFFECTS
▶Common or very common
▶With intra-uterine useBack pain.breast abnormalities.
depression.device expulsion.gastrointestinal discomfort
.headaches.hirsutism.increased risk of infection.libido
decreased.menstrual cycle irregularities.nausea.
nervousness.ovarian cyst.pelvic disorders.skin reactions
.uterine haemorrhage (on insertion).vaginal
haemorrhage (on insertion).vulvovaginal disorders.
weight increased
▶With oral useBreast tenderness.diarrhoea.dizziness.
fatigue.gastrointestinal discomfort.haemorrhage.
headaches.menstrual cycle irregularities.nausea.
vomiting
▶Uncommon
▶With intra-uterine useAlopecia.endometritis.oedema.
uterine rupture
▶Rare or very rare
▶With oral useFace oedema.pelvic pain.skin reactions
▶Frequency not known
▶With oral useCerebrovascular insufficiency.depressed
mood.diabetes mellitus.embolism and thrombosis.
neoplasms.sexual dysfunction.weight changesSIDE-EFFECTS, FURTHER INFORMATION
Breast cancerThere is a small increase in the risk of
having breast cancer diagnosed in women using, or who
have recently used, a progestogen-only contraceptive pill;
this relative risk may be due to an earlier diagnosis. The
most important risk factor appears to be the age at which
the contraceptive is stopped rather than the duration of
use; the risk disappears gradually during the 10 years after
stopping and there is no excess risk by 10 years. A possible
small increase in the risk of breast cancer should be
weighed against the benefits.
With intra-uterine useThere is no evidence of an
association between the levonorgestrel intra-uterine
system and breast cancer. The levonorgestrel intra-uterine
system should be avoided in patients with a history of
breast cancer; any consideration of it’s use should be by a
specialist in contraception and in consultation with the
patients cancer specialist.
Patients should be informed about the device that has
been inserted and when it should be removed or replaced
(including refering them to a patient information leaflet
and other sources of information).
Patients may experience irregular, prolonged or
infrequent menstrual bleeding in the 3 – 6 months
following insertion; bleeding pattern improves with time
but persists in some patients.
Progestogenic side-effects resolve with time (after the
first few months).
lPREGNANCY
▶With oral useNot known to be harmful.
▶With vaginal useIf an intra-uterine device fails and the
woman wishes to continue to full-term the device should
be removed in thefirst trimester if possible. Avoid; if
pregnancy occurs remove intra-uterine system.
lBREAST FEEDINGProgestogen-only contraceptives do not
affect lactation.
lHEPATIC IMPAIRMENT
▶With oral useManufacturer advises avoid in severe
impairment.
▶With intra-uterine useManufacturer advises avoid in severe
impairment—no information available; avoid in acute
hepatic disease.
lMONITORING REQUIREMENTS
▶With intra-uterine useGynaecological examination before
insertion, 4 – 6 weeks after insertion, then annually.
lDIRECTIONS FOR ADMINISTRATION
▶With intra-uterine useThe doctor or nurse administering (or
removing) the system should be fully trained in the technique
and should provide full counselling reinforced by the patient
information leaflet.
lPRESCRIBING AND DISPENSING INFORMATION
▶With intra-uterine useLevonorgestrel-releasing intra-
uterine devices vary in licensed indication, duration of use
and insertion technique—the MHRA recommends to
prescribe and dispense by brand name to avoid inadvertent
switching.
MIRENA®20MICROGRAMS/24HOURS INTRA-UTERINE
DEVICEWhen system is removed (and not immediately
replaced) and pregnancy is not desired, remove during the
first few days of menstruation, otherwise additional
precautions (e.g. barrier methods) should be used for at
least 7 days before removal.
JAYDESS®13.5MG INTRA-UTERINE DEVICEWhen system is
removed (and not immediately replaced) and pregnancy is
not desired, remove within 7 days of the onset of
menstruation; additional precautions (e.g. barrier
methods) should be used if the system is removed at some
other time during the cycle and there is intercourse within
7 days.
KYLEENA®19.5MG INTRA-UTERINE DEVICEWhen system is
removed (and not immediately replaced) and pregnancy is510 Contraception BNFC 2018 – 2019
Genito-urinary system7