- Medicines and Healthcare products Regulatory Agency
- 21 January 2016
- Therapeutic area:
- Endocrinology, diabetology and metabolism and Obstetrics, gynaecology and fertility
Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
Products containing 52 mg levonorgestrel
A levonorgestrel-releasing intrauterine system (IUS) has been available as the brand Mirena for a number of years. Recently, a second product called Levosert was licensed for use in the UK.
Although Mirena and Levosert both contain 52 mg levonorgestrel, they differ in 2 important ways.
Indications for use
- Mirena is licensed for 5 years’ use and Levosert is licensed for 3 years’ use in the indications of contraception or heavy menstrual bleeding. Clinical data for long-term efficacy and safety of Mirena for contraception and heavy menstrual bleeding are available for 5 years of use, whereas 3 years of data are currently available for Levosert
- Mirena is also licensed for 4 years’ use for endometrial protection as part of a hormone-replacement therapy regimen (Levosert is not licensed for this indication)
Introducer or insertion device
- Mirena and Levosert have different introducers, requiring different insertion techniques. Insertion (and removal) of any intra-uterine device (IUD) may be associated with pain, bleeding, and (in some cases) perforation of the uterus. Therefore, IUDs should only be inserted by healthcare professionals who are experienced in insertion or who have had training in the relevant insertion techniques
Product containing 13.5 mg levonorgestrel
A smaller IUS that contains 13.5 mg levonorgestrel (called Jaydess) has been marketed since 2014 and is licensed for 3 years’ use for contraception only. Note the advice for insertion above also applies to this product.
Reporting of adverse drug reactions
Suspected adverse drug reactions to these medicinal products should be reported to us, using the brand name, on a Yellow Card.
Article citation: Drug Safety Update volume 9 issue 6 January 2016: 2
Published: 21 January 2016