The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Bayer’s 52mg levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena® for extended use up to eight years for contraception in the UK.
The authorisation is based on the results of the Mirena Extension Trial (MET), evaluating the contraceptive efficacy and safety profile of Mirena® during extended use beyond five years and up to eight years (n=362), which demonstrated that contraceptive efficacy remains high with greater than 99% during years six to eight and showed a consistent adverse reaction profile in Years 6 through 8.
Dr Diana Mansour, Consultant in Community Gynaecology, Newcastle Hospitals, Community Health, and Past Vice President of the Faculty of Sexual and Reproductive Healthcare (FSRH), said: “Women in the UK will welcome the news that the Mirena levonorgestrel intrauterine system has now been granted an 8-year license for contraception and has a 5-year license for the treatment of heavy menstrual bleeding or, until symptoms return, up to 8 years.
“Some women may find the fitting or changing of an intrauterine device uncomfortable or embarrassing. Increasing the length of time when a device can be effective for contraception and heavy menstrual bleeding will help reduce these concerns as well as the potential risk of complications.”
The label update also includes symptom-driven extended use for the indication idiopathic menorrhagia (heavy menstrual bleeding). Mirena has a five-year license for the treatment of heavy menstrual bleeding. Should symptoms not return after five years of use, Mirena can be considered for continued use for up to eight years. The IUS should be removed or replaced after eight years at the latest.
“We are pleased to be able to offer women in the UK the extended use of Mirena in contraception, allowing a reduction in the number of IUS removal and insertion procedures for those who choose the IUS as their contraceptive method,” said Dr Joep Hufman MD, Medical Director at Bayer UK & Ireland.
“Bayer is committed to driving innovation in women’s healthcare and delivering solutions to meet women’s needs throughout key stages of their reproductive lives. We will continue to support women and their healthcare professionals to make individual decisions for a specific contraceptive method based on personal needs.”
