Jaydess IUS Study

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DTB: Drug and Therapeutics Bulletin

January 2015

Jaydess should be used with caution after specialist advice, or removal should be considered in women with existing or new severe headache, migraine, jaundice, severe arterial disease such as stroke or myocardial infarction, or marked increase in blood pressure.

Abstract

In the UK, around 75% of women of reproductive age use some form of contraception. Although combined oral contraceptives and barrier contraception are the most widely used, their effectiveness is dependent on their correct and consistent use. In contrast, long-acting reversible contraceptives provide effective and reliable methods of contraception that are not reliant upon user adherence. Jaydess (Bayer) is a new long-acting reversible levonorgestrel-releasing intra-uterine delivery system (IUS) that provides contraception for up to 3 years. It was launched in April 2014, and is the second levonorgestrel IUS available in the UK. Here we discuss the evidence for its effectiveness and safety, and consider its place in therapy.

Contraindications, special warnings and precautions for use

The contraindications, special warnings and precautions for Jaydess are broadly in line with those for Mirena. Contraindications to use include pregnancy, acute or recurrent PID, acute cervicitis or vaginitis, postpartum endometritis or infected abortion, abnormal vaginal bleeding, uterine or cervical malignancy, progestogen-sensitive tumours, and congenital or acquired uterine anomalies.

Jaydess is not recommended as the first choice in nulliparous women as clinical evidence in this group is limited. The company recommends that women considering the levonorgestrel IUS should be counselled on the signs, symptoms and risks of ectopic pregnancy. As an ectopic pregnancy may affect future fertility, the company advises that the benefits and risks of using Jaydess should be carefully evaluated, especially in nulliparous women.

Jaydess should be used with caution after specialist advice, or removal should be considered in women with existing or new severe headache, migraine, jaundice, severe arterial disease such as stroke or myocardial infarction, or marked increase in blood pressure. Although low-dose levonorgestrel may affect glucose tolerance, it is not usually necessary to alter the therapeutic regimen in women with diabetes.

Conclusion

Jaydess is a new levonorgestrel-releasing intra-uterine system (IUS) licensed for the prevention of pregnancy for up to 3 years. Evidence from one study suggests that Jaydess has a failure rate of approximately 0.4% at 1 year, and a cumulative failure rate of approximately 0.9% over 3 years. This is comparable to the failure rates reported with the correct and consistent use of other established methods of LARC, including Mirena. In one study, the proportion of women with amenorrhoea at 33–36 months was lower with Jaydess than with Mirena. The overall safety profile for Jaydess is consistent with that expected for a levonorgestrel-containing intra-uterine contraceptive. Despite the lower levonorgestrel release rate it does not appear to confer any significant advantages in terms of adverse effects over Mirena. However, there have been no direct comparisons between the versions of the two products currently available.

Whilst there may be a theoretical advantage of Jaydess's smaller frame, narrower insertion tube and lower levonorgestrel release rate compared with Mirena, this needs to be balanced by its shorter lifespan. Furthermore, Jaydess is not currently recommended as the first choice in nulliparous women as clinical evidence in this group is limited. In the absence of any major advantage in terms of efficacy, safety, user acceptability or cost there seems little reason to use Jaydess in preference to Mirena.

Read Entire Abstract at BMJ

BMJ - Drug and Therapeutics Bulletin (DTB)

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