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Mirena (levonorgestrel) intrauterine device
Australian Prescription Medicine Decision Summary
Published
Product name
Mirena
Active ingredient
Levonorgestrel
Submission type
Major Variation
Decision
Approved - duration of use for contraception extended from 5 to 8 years.
Decision date
Registration date
What this medicine was approved for
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.
How this medicine works
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.
Why the TGA approved or did not approve this medicine
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.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
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Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.