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Mirena (levonorgestrel) intrauterine device
Australian Prescription Medicine Decision Summary
Sponsor
Device/Product name
Mirena
Active Ingredient
Levonorgestrel
Date of decision
Published
Submission type
Major Variation
ATC codes
G02BA03 (Intrauterine contraceptives: plastic IUD with progestogen
Decision
Approved - duration of use for contraception extended from 5 to 8 years.
What was the decision based on
The approval was based on clinical data, including a Phase 3 clinical study. Contraceptive efficacy, pharmacokinetic and safety parameters were evaluated. The Phase 3 clinical study was designed to establish the safety and efficacy of the extended use of Mirena. It was conducted in the US and covered 3 years of extended use of Mirena resulting in a total duration of Mirena use up to 8 years. It assessed extended use beyond 5 years in women 18 to 35 years of age. The study demonstrated contraceptive efficacy up to 8 years that was comparable to that observed during the initial 5 year period. The safety profile for Mirena from 6 to 8 years of dosing was essentially unchanged from the first 5 years of dosing, with the types and frequency of adverse events during this period comparable to those observed in the first 5 years. Overall, there was a favourable benefit-risk balance of Mirena for contraception for the increase in duration from 5 years to 8 years.
What steps were involved in the decision process
This submission was evaluated under the standard prescription medicines registration process.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 1 June 2023 |
| Second round evaluation completed | 16 January 2024 |
| Registration decision (Outcome) | 5 June 2024 |
| Administrative activities and registration in the ARTG completed | 7 June 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 254 |
*Statutory timeframe for standard submissions is 255 working days
Date of entry onto ARTG
Black triangle scheme
Not required
Dose forms
Mirena consists of a T-shaped polyethylene frame (T-body) with a levonorgestrel-containing cylinder around the vertical stem. The cylinder is covered with a membrane regulating the release of the hormone. The total amount of levonorgestrel in the device is 52 mg. The T-shaped frame is impregnated with barium sulfate to make the system detectable by X-ray. Brown monofilament polyethylene removal threads are attached to the lower end of the vertical arm (the loop). The vertical stem of the IUS is loaded in the insertion tube at the tip of the inserter.
Strength
Levonorgestrel 52mg.
Other ingredients
- Dimethylsiloxane / methylvinylsiloxane cross linked elastomer
- colloidal anhydrous silica,
- polyethylene,
- barium sulfate,
- iron oxide black CI77499.
Containers
Mirena is packaged in a polyethylene terephthalate glycol sachet sealed with a peelable polyethylene film.
Pack sizes
Each pack contains one intrauterine system.
Dosage
The average daily levonorgestrel release rates are approximately 20 μg/day during the first year, 15 μg/day during the first 5 years and 13 μg/day over the complete 8 year period of use.
Pregnancy category
B3:
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Mirena is not to be used during an existing or suspected pregnancy. If pregnancy occurs during Mirena use, removal of the system is recommended, since any intrauterine contraceptive device left in the uterus may increase the risk of abortion and preterm labour. Removal of Mirena or probing of the uterus may result in spontaneous abortion. Ectopic pregnancy should be excluded. The relative risk of ectopic pregnancy is increased during Mirena use.
If the intrauterine contraceptive device cannot be gently removed, termination of the pregnancy may be considered. If the pregnancy is allowed to proceed and the system cannot be withdrawn, the heightened risks and the possible consequences of premature birth to the infant should be conveyed. The course of such a pregnancy should be monitored closely. The recipient of the device should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Mirena is not to be used during an existing or suspected pregnancy. If pregnancy occurs during Mirena use, removal of the system is recommended, since any intrauterine contraceptive device left in the uterus may increase the risk of abortion and preterm labour. Removal of Mirena or probing of the uterus may result in spontaneous abortion. Ectopic pregnancy should be excluded. The relative risk of ectopic pregnancy is increased during Mirena use.
If the intrauterine contraceptive device cannot be gently removed, termination of the pregnancy may be considered. If the pregnancy is allowed to proceed and the system cannot be withdrawn, the heightened risks and the possible consequences of premature birth to the infant should be conveyed. The course of such a pregnancy should be monitored closely. The recipient of the device should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever.
What was approved
Mirena, a levonorgestrel-releasing intrauterine system is a long-acting reversible contraceptive.
The duration for use as a contraceptive has been extended from 5 years to 8 years.
What is this medicine and how does it work
Mirena is a hormonal intrauterine device (IUD), a type of birth control. The Mirena IUD is a small ‘T- shaped’ plastic device that is inserted into the uterus. Mirena releases a synthetic version of the hormone progesterone (made naturally by the ovaries) called levonorgestrel, which provides long-term contraception. A coating (membrane) on the IUD controls the slow release of levonorgestrel into the uterus.
Levonorgestrel prevents pregnancy by:
-preventing sperm from accessing and fertilising eggs by making the normal mucus in the cervical canal (opening to the uterus) thicker.
-controlling the monthly development of the uterine lining so that it is not thick enough to allow implantation of fertilised eggs.
-preventing ovulation (the release of eggs) in some women.
Levonorgestrel prevents pregnancy by:
-preventing sperm from accessing and fertilising eggs by making the normal mucus in the cervical canal (opening to the uterus) thicker.
-controlling the monthly development of the uterine lining so that it is not thick enough to allow implantation of fertilised eggs.
-preventing ovulation (the release of eggs) in some women.