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Welcome to Women's Health Matters, an online resource to support healthcare professionals involved in the area of Women's Health.

Mirena® (Levonorgestrel)

Up to 5 years of highly effective contraception1

Mirena® is a hormonal intrauterine system that provides both contraceptive protection and treatment of heavy menstrual bleeding (HMB) for up to 5 years. It is inserted into the uterus and releases the hormone levonorgestrel in small doses (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 HMB
  • 5 years of contraceptive efficacy
  • 4 years of endometrial protection

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

  • Contraception
  • Idiopathic menorrhagia. Mirena may be particularly useful in women with idiopathic menorrhagia requiring (reversible) contraception
  • Protection from endometrial hyperplasia during oestrogen replacement therapy

Mirena® Prescribing information

  1. Mirena® Summary of Product Characteristics.

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

  1. Bayer PLC. Mirena® product information. Bayer Australia, 2017

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

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

Steps 1 & 2

1.  Open the sterile packaging of the T-Safe® CU 380A QL.

2.   While holding the nylon threads (e) straight, place the plunger (c) into the insertion body (b) up to the lower end of the IUD stem (f). By carefully pushing the plunger up to the blue marking on the insertion tube (a), both side arms (g) of the IUD slip into the tube. The upper end of the now ready-loaded IUD must jut only 2 mm out of the insertion tube.

Steps 1 & 2

Steps 3 & 4

3.  Adjust the sliding blue flange (d) so that the length of the insertion tube above it corresponds to the depth of the uterus as previously measured by hysterometry. Ensure that the wider part of the flange is parallel to the side arms of the ready-loaded IUD as this indicates the direction in which the side arms of the IUD will open in the uterus.

4.  Carefully introduce the insertion tube with the loaded T-Safe® CU 380A QL into the uterine cavity until it touches the fundus of the uterus. The sliding blue flange must be in contact with the cervix.

Steps 3 & 4

Steps 5 & 6

5.  Holding the plunger steady, pull the insertion body downwards to the base of the plunger. The side arms of the IUD are now entirely released in the uterus.

6.   To prevent pulling the device from its fundal position, first remove the plunger while keeping the insertion body steady and only then remove the insertion body. Cut the threads leaving 2-3 cm visible outside the cervix.

Steps 5 & 6

NOTE: Due to the soft and flexible insertion tube, the side arms may twist while being pushed upwards. Please adjust the sliding blue flange as described in step 3, above. The side arms of the T-Safe® CU 380A QL must not remain bent for over five minutes within the insertion tube, or they may not bend back completely and may not return to their original 90° angle.

How does Mirena® work?

The contraceptive effect of Mirena® is based on a 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

Refer to the IUC myth busters for help in combating common patient concerns.

Go to online learning module

  1. Mirena® Product monograph, 9th edition, 2010.
  2. Peipert J, et al. Obstet Gynecol, 2011;117:1105–13.
  3. Madden T, et al. Contraception, 2013;88(2):243–249.

NICE recommends a levonorgestrel-releasing (LNG) IUS, like Mirena®, as a first-line option for heavy menstrual bleeding (HMB).1

Read the latest NICE clinical guidance on Heavy menstrual bleeding: assessment and management (2018)

Clinical Guidance

1. NICE guideline NG88. Heavy menstrual bleeding: assessment and management (November 2018).
Available at: https://www.nice.org.uk/guidance/ng88. Last accessed: October 2019.

Mirena® has high rates of patient satisfaction

83%

of HMB patients are satisfied with Mirena®.1

More info

95%

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

More info
Mirena Prescribing Information

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

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

Mirena® is a trusted choice for you and your patients

Over 26 years of

clinical experience1

More than 270 clinical trials

and over 5000 peer-reviewed publications to date2

An estimated 43.7 million

insertions worldwide3

  1. Kailasam C and Cahill D. Patient Prefer Adherence. 2008; 2:293–302.
  2. PubMed www.ncbi.nlm.nih.gov/pubmed: search result (Mirena contraceptive) . Last accessed 16 December 2019.
  3. Data on file. Mirena® Insertion data 2017. Bayer Healthcare.

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® would also be an option for a woman requiring the progestogenic component of hormone replacement therapy (HRT).

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    Mirena is indicated for contraceptive use for up to 5 years, as a treatment option for 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

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    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'.
      • The chance of irregular bleeding can happen in the first 3 - 6 months after insertion.

    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

    Mairina

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

      2. Merki-Feld GS, et al. Eur J Contracept Reprod Health Care 2018;23:183–193.

      3. Peiper FJ, et al. Obstet Gynecol 2010;120:1291–1297.

      4. PULSE survey 2018 UK.

      5. gov.uk. Intrauterine contraception: uterine perforation—updated information on risk factors [online]. Updated 26 June 2015. Available from: https://www.gov.uk/drug-safety-update/intrauterine-contraception-uterine-perforation-updated-information-on-risk-factors [Last accessed: August 2019].

      6. Whitaker A, et al. Contraception 2008;78:211–217.

    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.

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    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
    • inflammation of the vulva and vagina
    • 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.

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    Report Adverse Events
    Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk. Adverse events should also be reported to Bayer plc Tel: 01182063500, Fax: 01182063703, Email: pvuk@bayer.com.

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

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    Depression has been reported in fewer 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

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

      7. European Medicines Agency. PRAC assessment on the use of combined hormonal contraception and suicidality [online]. Available from: https://www.ema.europa.eu/documents/prac-recommendation/prac-recommendations-signals-adopted-1-4-october-2018-prac-meeting_en.pdf [Last accessed: August 2019].

    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, Mirena® usually results in lighter periods and can decrease blood loss by up to 94% at 3 cycles and 88% at 6 cycles.8

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

      8. Reid PC and Virtanen-Kari S. BJOG 2005;112:1121–1125.

    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

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    11. Andersson K, et al. Contraception 1992;45:575–584.

    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

    Accordingly, removal of the intrauterine device (IUD) Mirena® or probing of the uterus may also 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.

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    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

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    12. NICE. Contraception - IUS/IUD [online]. Updated May 2019. Available from: https://cks.nice.org.uk/contraception-iusiud [Last accessed: August 2019].

    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 methods.10

      1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].

    10. Faculty of Sexual and Reproductive Healthcare. Clinical guideline. Intrauterine contraception clinical effectiveness unit [online]. Updated October 2015. Available from: https://www.fsrh.org/standards-and-guidance/documents/ceuguidanceintrauterinecontraception/ [Last accessed: August 2019].

    Recommendations

    Counselling patients

    Read more

    Kyleena® (19.5 mg intrauterine delivery system levonorgestrel)

    Read more

    References

    1. Bayer Plc. Mirena® (52 mg intrauterine delivery system levonorgestrel): Summary of Product Characteristics [online]. Updated 17 October 2019. Available from: https://www.medicines.org.uk/emc/product/1132/smpc [Last accessed: August 2019].
    2. Merki-Feld GS, et al. Eur J Contracept Reprod Health Care 2018;23:183–193.
    3. Peiper FJ, et al. Obstet Gynecol 2010;120:1291–1297.
    4. PULSE survey 2018 UK.
    5. gov.uk. Intrauterine contraception: uterine perforation—updated information on risk factors [online]. Updated 26 June 2015. Available from: https://www.gov.uk/drug-safety-update/intrauterine-contraception-uterine-perforation-updated-information-on-risk-factors [Last accessed: August 2019].
    6. Whitaker A, et al. Contraception 2008;78:211–217.
    7. European Medicines Agency. PRAC assessment on the use of combined hormonal contraception and suicidality [online]. Available from: https://www.ema.europa.eu/documents/prac-recommendation/prac-recommendations-signals-adopted-1-4-october-2018-prac-meeting_en.pdf [Last accessed: August 2019].
    8. Reid PC and Virtanen-Kari S. BJOG 2005;112:1121–1125.
    9. NICE clinical guideline [CG30]. Long-acting reversible contraception [online]. Updated September 2014. Available from: https://www.nice.org.uk/guidance/cg30 [Last accessed: August 2019].
    10. Faculty of Sexual and Reproductive Healthcare. Clinical guideline. Intrauterine contraception clinical effectiveness unit [online]. Updated October 2015. Available from: https://www.fsrh.org/standards-and-guidance/documents/ceuguidanceintrauterinecontraception/ [Last accessed: August 2019].
    11. Carr BR, et al. Return of fertility in nulliparous and parous women after levonorgestrel 52 mg intrauterine system discontinuation [ASRM abstract O-104]. Fertil Steril. 2018;110(45 suppl):e46.
    12. NICE. Contraception - IUS/IUD [online]. Updated May 2019. Available from: https://cks.nice.org.uk/contraception-iusiud [Last accessed: August 2019].

    Report Adverse Events
    Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk. Adverse events should also be reported to Bayer plc Tel: 01182063500, Fax: 01182063703, Email: pvuk@bayer.com.


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    • PP-PF-WHC-GB-0484 July 2020

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    Bayer plc

    This website is intended for UK healthcare professionals only. Women’s Health Matters is organised and funded by Bayer and contains promotional content.

    Prescribing Information (PI) can be found via the links below:
    Mirena® (52 mg intrauterine delivery system Levonorgestrel)
    Kyleena® (19.5 mg intrauterine delivery system Levonorgestrel)
    Jaydess® (13.5 mg intrauterine delivery system Levonorgestrel)
    Qlaira® (estradiol valerate/dienogest)
    Microgynon® (levonorgestrel/ethinylestradiol)

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