Product information

Mirena® (52mg levonorgestrel)

 

prescribing information

Mirena® is a trusted choice for you and your patients

Over 26 years

of clinical experience1

 

More than 945 clinical trials

and over 4300 peer-reviewed publications to date2

 

An estimated 57.5 million

insertions worldwide3

 

Only intrauterine system licensed

for protection from endometrial hyperplasia during oestrogen replacement therapy in the uk4

Mirena® is a hormonal intrauterine system that provides both contraceptive protection and treatment of idiopathic heavy menstrual bleeding (HMB) for up to 5 years. It is inserted into the uterus and releases the hormone levonorgestrel in small doses (initially 20 μg/24 hours) into the uterine cavity.

Mirena® has the broadest range of indications and the longest licensed duration of action for an IUS, offering:1

 
  • 5 years of effective relief from idiopathic HMB
  • 5 years of contraceptive efficacy
  • 4 years of protection from endometrial hyperplasia during oestrogen replacement therapy

 

The local release of hormone ensures low systemic levels of levonorgestrel, meaning that the incidence of hormone-related adverse events is low.

Mirena® therapeutic indications1

 

  • Contraceptive efficacy, up to 5 years
  • Effective relief from idiopathic Heavy Menstrual bleeding, up to 5 years.
  • Protection from endometrial hyperplasia during oestrogen replacement therapy, for up to 4 years.

 

Mirena® prescribing information

Mirena® is recommended as a treatment option for idiopathic Heavy Menstrual Bleeding(HMB) by national and international guidelines1-6

*NICE and CNGOF guidelines recommend Mirena® as a first-line treatment option in idiopathic HMB 

UK Flag

NICE

National Institute for Health and Clinical Excellence

UK Flag

FSRH

Faculty of Sexual and Reproductive Healthcare

France Flag

CNGOF

French College of Obstetricians and Gynecologists

USA Flag

ACOG

American College of Obstetricians and Gynecologists

Brazil Flag

FEBRASGO

federaçao Brasileira das Associações de Ginecologia e Obstetricia

Canada Flag

SOGC

Society of Obstetricians and Gynaecologists of Canada

Mirena® opens out to a T-shaped plastic frame with a cylinder-shaped reservoir around the vertical arm of the frame. The reservoir contains the progestogen levonorgestrel.

The size of Mirena® is approximately 32 mm x 32 mm.1

 

Mirena in Uterus
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Patient Booklet for Mirena® (levonorgestrel)

A digital guide to your Mirena®. This leaflet is intended for women who have been prescribed Mirena®. Please read the patient information leaflet (PIL) included in the Mirena® box for full details.

Download Download
How small is Mirena?

Watch step-by-step video guidance on the preparation, insertion, removal and replacement of the Mirena® IUS here.

 

Watch step-by-step video guidance on the preparation, insertion, removal and replacement of the Mirena IUS

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How does Mirena® work?

The contraceptive effect of Mirena® is based on the local effect of levonorgestrel.1

 

How does Mirena® work?

 

  1. The cervical mucus is thickened making it difficult for the sperm to get through to fertilise the egg.
  2. Normal sperm movement and function inside the uterus and ovarian tubes is inhibited.
  3. The growth of the lining of the uterus (endometrium) is reduced, which also makes menstrual blood loss much lighter and shorter.

 

Due to these changes in the endometrium, many women will have spotting and irregular bleeding during the first 3-6 months following the insertion of Mirena®. Thereafter, the strong suppression of the endometrium results in shorter and lighter periods.

 

Understanding the bleeding pattern is an essential aspect of counselling and appropriate patient education has been shown to promote continuation.2,3

Mirena® has high rates of patient satisfaction

The contraceptive effect of Mirena® is based on the local effect of levonorgestrel.1

 

83%

of HMB patients are satisfied with Mirena®1

 

More information

 

95%

of first-time users of Mirena® for contraception are satisfied, rising to 99% of those on their second Mirena® IUS2

 

More information

Wendy describes the impact of heavy menstrual bleeding on her life before and after Mirena

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Mirena® Prescribing Information

 

Wendy describes the impact of heavy menstrual bleeding on her life before and after Mirena®

  • Xu L, et al. International Journal of Women’s Health. 2014;6:547–554. Return to content
  • Romer T and Linsberger D. The European Journal of Contraception and Reproductive Health Care. 2009;14(6):391–398. Return to content

Mirena®: Significantly reduces the burden of menstrual blood loss from baseline as early as three cycles.1

Mirena® Significantly reduces the blood loss in as early as three cycles (p<0.001)

 

Mirena Significantly reduces the burden of menstrual blood loss as early as three cycles

Mirena®: Frequently asked questions

Below you will find answers to some commonly asked questions, which you may find useful when assessing appropriate contraceptive options for patients or counselling patients on contraception choice and Mirena® (52 mg intrauterine delivery system levonorgestrel).

    Women who suffer from idiopathic menorrhagia or require endometrial protection during oestrogen replacement therapy may benefit from Mirena® (52 mg intrauterine delivery system levonorgestrel), which is indicated as a contraceptive option that prevents pregnancy and as a treatment option for both conditions.1

     

    Mirena® is a long-acting reversible contraceptive device that may be particularly useful in women with idiopathic menorrhagia (also known as heavy menstrual bleeding) who also require (reversible) contraception.1

    Mirena® is indicated for contraceptive use for up to 5 years, as a treatment option for idiopathic menorrhagia for up to 5 years and as protection from endometrial hyperplasia during oestrogen replacement therapy for up to 4 years. If the patient wishes to continue using the same method, it can be replaced by a new system at any time of the cycle at the same time, in which case no additional protection is required.1

    A recent study of more than 6,000 women showed that 73% across all age ranges (18–49) would consider long-acting reversible contraception (LARC) if provided with substantial information from their healthcare professional (HCP) on this method (compared with 38% estimated by HCPs).2

     

    In general, fewer patients are uncomfortable with the idea of having a foreign device inside their bodies if they were previously aware of an LNG-IUS such as Mirena® (52 mg intrauterine delivery system levonorgestrel) vs those who were not aware. This highlights the importance of effective counselling to increase awareness and knowledge.3

     

    A patient may feel reticent to have a Mirena® (52 mg intrauterine delivery system levonorgestrel) inserted, this could be due to the following myths and misperceptions:

     

    • 'Fitting and removal will be painful'.
      • Some patients may feel pain or have some bleeding during insertion or removal1
         
    • 'The IUS will perforate and end up somewhere other than my uterus without me knowing'.
      • Perforation occurs in less than 1 in 1000 women and can be detected by severe pelvic pain and continued heavy bleeding for more than a few weeks after insertion5
         
    • 'I will suffer years of irregular bleeding'.
      • Irregular bleeding may happen during the first 3-6 months after insertion, the frequency decreases with continued use.
         

    Women have other perceptions of IUS which it is important to counsel them around:

     

    • 11% of women consider the hormone level to be very high4
    • 30% of women are opposed to having something like a hormonal coil inserted in their body4
    • 37% of women feel they don’t know enough about hormonal coils4

     

    However, a study by Whitaker et al showed that adolescents and young women report a positive attitude towards intrauterine contraceptives before and after a 3-minute educational intervention counselling tool, which included information about IUS effectiveness, insertion and removal process, risks, benefits, costs, effect on fertility, menstrual effects, length of use, similarities and differences between types of IUSs available. Attitudes before and after the education intervention were assessed by questionnaire.6

     

    Bayer-led survey of 506 women (105 LARC users) in the UK who were either using and/or considering birth control to understand consumer insights.

     

    Graph adapted from Whitaker AK et al. Contraception. 2008.

    contraception chart

     

    *women who had heard of IUD previously, n=57
    **all women, n=144

    The intrauterine device Mirena® contains levonorgestrel 52 mg. Levonorgestrel is a well-established progestogen with antioestrogenic activity.1

     

    The effect of hormonal contraceptives such as Mirena® may be reduced by medicines that increase the amounts of enzymes made by the liver. These include:1

     

    • Medicines used to treat epilepsy
    • Antifungal medicines (e.g. griseofulvin, fluconazole, itraconazole, ketoconazole, voriconazole)
    • Certain antibiotics (rifampicin & macrolides [e.g. clarithromycin, erythromycin])
    • Medicines used to treat HIV and Hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors)
    • Certain sedatives (called barbiturates)
    • Medicines used to treat chest pain (angina) and/or high blood pressure
    • Products containing St John’s Wort (a herbal remedy)

     

    For a full list of medicinal interactions with Mirena® and contraindications, refer to the Summary of Product Characteristics.

    Undesirable effects are more common during the first months after the insertion of Mirena® (52 mg intrauterine delivery system levonorgestrel) and subside during prolonged use.

     

    In less than 1 in 10 women, common side effects of Mirena® include:1

     

    • ovarian cysts
    • painful periods
    • weight gain
    • depression, nervousness
    • headache
    • migraine
    • abdominal, pelvic or back pain
    • nausea
    • acne
    • increased growth of hair on the face and body
    • reduced sex drive
    • increased vaginal discharge
    • tender, painful breasts
    • Mirena® expulsion

     

    Very common undesirable effects (occurring in more than 10% of users) include uterine/vaginal bleeding including spotting, oligomenorrhoea (infrequent periods) and amenorrhoea (an absence of periods).1

     

    For a full list of potential side effects, refer to the Summary of Product Characteristics.

     

    If the patient does experience side effects, they should speak to a doctor, pharmacist or nurse. This includes any possible side effects not listed in the contraception package leaflet.

    Reporting adverse events and quality complaints

    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bayer plc.

     

    If you want to report an adverse event or quality complaint, reports can be directed to: Tel: 01182063500 or email: pvuk@bayer.com

     

    Further information is available on the “contact” tab at www.bayer.co.uk.

    Weight gain has been reported as common (can occur in 1 in 100 or more but less than 1 in 10 women) in women fitted with Mirena® (52 mg intrauterine delivery system levonorgestrel).1

    Depression has been reported in 1 in 100 or more but less than 1 in 10 women fitted with Mirena® (52 mg intrauterine delivery system levonorgestrel).1

     

    There is no clear data to establish whether there is an increased risk of suicidal thoughts and behaviour associated with the use of hormonal contraceptives. Depressed mood and depression are well-known undesirable effects of hormonal contraceptive use. Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide. Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment.7

    Mirena® (52 mg intrauterine delivery system levonorgestrel) will affect the patient’s menstrual cycle.8

     

    Patients fitted with the Mirena® coil may experience lighter bleeding or some spotting (light bleeding in between periods) and irregular bleeding during the first 3–6 months after it is fitted.1

     

    Some patients may have prolonged or heavy bleeding or an increase in the frequency of bleeding, usually in the first 2–3 months, before a reduction in blood loss is achieved.1

     

    However, overall patients are likely to have fewer days bleeding in each month and might eventually have no periods at all. This is due to the effect of the hormone (levonorgestrel) on the lining of the womb.1

     

    For women with menorrhagia (n=25), Mirena resulted in lighter periods and decreased blood loss by 90% (AR-110 mL) at 3 cycles and 96% (AR 117 mlL) at 6 cycles.8

     

    Study: Randomised, open-label phase 3 trial involving 51 women with objective menorrhagia to compare the efficacy and tolerability of Mirena with oral mefenamic acid.

    Fertility is restored immediately and conception can occur from the first cycle following removal of the system.11

     

    Studies have suggested that in women who discontinue Mirena® (52 mg intrauterine delivery system levonorgestrel) for planned pregnancy the pregnancy rate at one year is similar to those who do not use contraception.1

    If a patient becomes pregnant while Mirena® (52 mg intrauterine delivery system levonorgestrel) is in place, ectopic pregnancy should be excluded, the system must be removed and termination of the pregnancy should be considered.1

     

    Removal of the intrauterine device (IUD) Mirena® or probing of the uterus may result in spontaneous miscarriage. If the patient wishes to continue the pregnancy and the system cannot be withdrawn, she should be informed about the increased risks and the possible consequences of premature birth to the infant. Such pregnancies should be closely monitored. The patient should be instructed to report all symptoms that suggest complications of the pregnancy, like cramping abdominal pain with fever.1

     

    For more information and a complete list of contraindications, refer to the Mirena® Summary of Product Characteristics.

    In women of fertile age, Mirena® (52 mg intrauterine delivery system levonorgestrel) is inserted into the uterine cavity within 7 days of the onset of menstruation. It can be replaced by a new system at any time of the cycle.

     

    Mirena® should be inserted during the patient’s menstrual cycle or within 7 days from the beginning of the period.1

     

    Some patients may find the fitting of a Mirena® coil uncomfortable.1 Managing your patient’s expectations with regards to pain is important and many healthcare professionals have found that talking to the patient throughout the fitting helps to reduce anxiety and make them more comfortable. However, it is important to check with your patient if this would be helpful.

     

    The National Institute for Health and Care Excellence (NICE) guidelines for long-acting reversible contraceptives (LARC) recommends: 'insertion of an intrauterine device/intrauterine system may cause pain and discomfort for a few hours and light bleeding for a few days, and they should be informed about appropriate pain relief'.12

    Some patients may feel pain or have some bleeding during insertion or removal of Mirena®.1

     

    Clinical guidance from the Faculty of Sexual and Reproductive Healthcare states that there is no evidence from current trials to support the use of topical lidocaine, misoprostol or non-steroidal inflammatory drugs (NSAIDs) for improving ease of insertion or reducing pain during insertion of intrauterine devices.10

    Reporting adverse events and quality complaints

    Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Bayer plc.

     

    If you want to report an adverse event or quality complaint, reports can be directed to: Tel: 011820‍63500 or email: pvuk@bayer.com

     

    Further information is available on the “contact” tab at www.bayer.co.uk.