Key points

  • On 1 March 2020, levonorgestrel (Kyleena) was listed on the PBS General Schedule (Restricted Benefit)
    Kyleena is a long-acting reversible contraception (LARC) progestogen-releasing intrauterine device (IUD) for contraception that delivers 19.5 mg of levonorgestrel over 5 years.
  • LARCs are the most effective reversible contraceptive methods available
    LARCs are more effective at reducing unintended pregnancy than short-term options.
  • Kyleena has a comparable safety and efficacy profile to Mirena, a LARC containing levonorgestrel 52 mg
    Kyleena has fewer progestogen-related side effects than Mirena, but a 2% higher risk of unplanned pregnancy which could be clinically significant for women.
  • Women should be given accurate, evidence-based information on the safety, efficacy, advantages and disadvantages of contraceptive methods
    Choice of contraception should be based on accurate information, personal needs and preferences, and medical suitability.

New PBS listing

On 1 March 2020, levonorgestrel 19.5 mg (Kyleena) intrauterine device (IUD) was listed on the PBS General Schedule (Restricted Benefit) for women requesting contraception.1

See the PBS website for complete details.

Kyleena may be prescribed by nurse practitioners

Authorised nurse practitioners may prescribe this medicine on the PBS. See the PBS website for more information on nurse practitioner PBS prescribing.


Why was the new listing made?

The recommendation to list Kyleena on the PBS was based on the following comparison to Mirena:2

  • acceptable cost-effectiveness based on a cost-minimisation approach
  • lower dose of levonorgestrel with comparable contraceptive effectiveness
  • lower risk of progestogen-related ovarian cysts.

What is it?

Kyleena is a progestogen-only, long-acting reversible contraceptive (LARC) intrauterine drug delivery device (IUD) containing a low dose of levonorgestrel (19.5 mg).3,4

Kyleena is effective for 5 years. It releases approximately 17.5 micrograms/day of levonorgestrel over 24 days after insertion, and has an average in vivo release rate of approximately 9 micrograms/day over 5 years.3,4


How does it compare?

At the March 2019 PBAC meeting, Mirena was accepted as the appropriate comparator for Kyleena.

Table 1: Comparison of Kyleena and Mirena2-7




Therapeutic class

A progestogen-only agent of the 19-nortestosterone class

A progestogen-only agent of the 19-nortestosterone class

Pharmacological action

Characteristic gestagenic properties, antigonadotropic action and antioestrogenic effects

Characteristic gestagenic properties, antigonadotropic action and antioestrogenic effects

Course of duration

Up to 5 years

Up to 5 years


Levonorgestrel 19.5 mg

Levonorgestrel 52 mg

Mean daily dose

9 micrograms/day over 5 years

14 micrograms/day over 5 years

TGA-approved indications

Contraception for up to 5 years


Treatment of idiopathic menorrhagia

Prevention of endometrial hyperplasia during oestrogen replacement therapy

PBS criteria



Idiopathic menorrhagia (the treatment must be for a patient for whom oral treatments are ineffective, or contraindicated)


The PBAC noted at its March 2019 meeting that women using Kyleena had a numerically higher risk of unplanned pregnancies compared with those using Mirena (2% vs 0%, respectively). Although these results did not reach statistical significance, it was noted that the outcome of an unplanned pregnancy would be clinically significant for women. Additionally, the PBAC noted that the efficacy of Kyleena may have been overestimated in the submission. However, the PBAC considered that on balance, the claim that Kyleena is non-inferior in efficacy to Mirena to be reasonable and the results indicated that Kyleena was comparable to Mirena in terms of contraceptive effectiveness.2


The PBAC accepted the claim that Kyleena was non-inferior in terms of safety to Mirena at its March 2019 meeting. The PBAC noted that women treated with Kyleena were significantly less likely to develop ovarian cysts than those treated with Mirena (risk difference –15.4%, 95% CI –21.9% to –8.6%; p<0.001).2,7

Read the Product Information for full list of risks and safety issues.


Will the changes affect current prescribing or health services?

Women seeking contraception should be given accurate, evidence-based information on the safety, efficacy, advantages and disadvantages of all contraceptive methods before making their choice.8

The listing of levonorgestrel 19.5 mg (Kyleena) offers a lower-dose LARC option for women who are seeking contraception. Given the comparable efficacy and safety of Kyleena and Mirena, the choice of LARC will be primarily driven by patient preferences, eg potential ease of insertion and impact of progestogen dose.2 Women should also be informed about the comparative potential failure rates to help them decide which LARC they will use. See Table 2.

Table 2. Considerations for discussion with patients




Risk of pregnancy over 3 years2,7

Slightly higher (2%)

Lower (0%)

Difference is not statistically significant but may be clinically significant for women.

Risk of ovarian cysts over 3 years7

Less likely (8.6%)

More likely (22%)

Difference is statistically significant.

Bleeding and spotting days over 3 years7

More likely due to lower progestogen

Less likely due to higher progestogen

Dimensions / ease of insertion and removal4,5,7

28 mm width, 30 mm height: may be easier to insert/remove due to smaller size

32 mm width, 32 mm height: may be more difficult to insert/remove due to larger size

Partial or complete expulsion over 3 years2,7

Low risk (2%)

Low risk (1.6%)


What else should health professionals know?

LARC methods are the most effective reversible methods available and more effective at reducing unintended pregnancy than other short-term options.9,10

While LARC options are recommended as first-line contraception for nulliparous women by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG), there are mixed positions in Australian and UK guidelines on their place in therapy. They all agree however, that discussion of contraceptive options should prioritise choice and safety11 and women should be provided with the method of contraception that is most acceptable to them as long as it is not contraindicated.12

The PBAC noted the value of Kyleena for younger and nulliparous women, who may prefer a lower hormone dose, due to potential systemic hormonal side effects with higher doses.2

Another potential benefit is Kyleena’s smaller size may facilitate easier and less painful insertion and removal compared to other IUDs.2

Kyleena should only be inserted by a health professional trained and experienced in IUD insertions.4,11

See the Product Information and instructions found in the package for complete steps on the insertion, removal and replacement of Kyleena.

Active ingredient prescribing

On 31 October 2019, the National Health (Pharmaceutical Benefits) Regulations 2017 were amended to require the inclusion of active ingredients on most PBS prescriptions. Active ingredient prescribing is part of a wider government strategy to ensure consistent and standardised medicines information.13

Active ingredient prescribing aims to:13

  • ensure the identification of active ingredient names on all PBS prescriptions
  • increase patient understanding of the medicines they are taking
  • promote the uptake of generic medicines.

Under the regulations, prescribers:13

  • are required to include the active ingredient on all PBS prescriptions (excluding handwritten prescriptions, paper-based medication charts in residential aged care settings, and medicines with four or more active ingredients or medicines listed as ‘various’ under the PBS and RPBS).
  • can include a brand after the active ingredient on a prescription, if the doctor believes the identification of a brand is necessary for the clinical treatment of their patient.

A 12-month transition period has been arranged to ensure prescribers have sufficient time to update prescribing software to versions which meet the new active ingredient prescribing requirements.13


What should patients know?

Explain the benefits, risks and side effects associated with an IUD.

It is also important for women to know about the associated costs and who can insert the IUD. A referral to a gynaecologist or advice from Family Planning may be required.

Advise patients that insertion of Kyleena may be associated with pain and may precipitate a vasovagal response (fainting).4

Irregular bleeding and spotting are common in the first months following insertion of Kyleena. If bleeding becomes heavier and/or more irregular over time, symptoms should be investigated.4

Inform patients that they should return for a pelvic examination 4–12 weeks after IUD insertion to check for pelvic tenderness and the length of the device’s threads. Follow-up should continue at least once a year, or more frequently if clinically indicated.4,14

Symptoms of partial or complete expulsion of Kyleena may include bleeding or pain. However, it is important to inform patients that IUDs can be expelled unnoticed from the uterine cavity.4 Patients should seek medical advice if they suspect expulsion or displacement of the IUD.4

Advise patients to seek medical advice immediately if they develop pelvic pain, notice a dramatic change in bleeding patterns after the initial changes have settled, or experience pain during intercourse.11

Advise patients that IUDs do not protect against sexually transmitted infections including HIV/AIDs.4 Kyleena should be used in combination with condoms to reduce the chance of contracting a sexually transmitted infection.4

Advise patients that Kyleena and Mirena are not substitutable at the pharmacist level.


More information

Family Planning Alliance Australia: See your State or Territory's family planning clinics.



  1. Pharmaceutical Benefits Scheme. Schedule of Pharmaceutical Benefits - Summary of changes 1 March 2020. Canberra: Australian Government Department of Health, 2020 (accessed 18 March 2020).
  2. Pharmaceutical Benefits Scheme. Public Summary Documents: Levonorgestrel (March 2019 PBAC Meeting). Canberra: Australian Government Department of Health, 2019 (accessed 9 July 2019).
  3. Therapeutic Goods Administration. AUSPAR for levonorgestrel. Canberra: Australian Government Department of Health, 2017 (accessed 5 March 2020).
  4. Bayer Australia Ltd. Levonorgestrel (Kyleena) product information. Sydney: Bayer Australia Ltd, 2018 (accessed 20 February 2020).
  5. Bayer Australia Ltd. Levonorgestrel (Mirena) product information. Sydney: Bayer Australia Ltd, 2018 (accessed 20 February 2020).
  6. Pharmaceutical Benefits Scheme. PBS Schedule: Levonorgestrel. Canberra: Australian Government Department of Health, 2019 (accessed 20 February 2020).
  7. Gemzell-Danielsson K, Schellschmidt I, Apter D. A randomized, phase II study describing the efficacy, bleeding profile, and safety of two low-dose levonorgestrel-releasing intrauterine contraceptive systems and Mirena. Fertil Steril 2012;97:616-22 e1-3.
  8. Family Planning Alliance Australia. Long acting reversible contraception (LARC) - Position statement. Brisbane: FPAA, 2014 (accessed 3 March 2020).
  9. Royal Australian and New Zealand College of Obstetricians and Gynaecologists. Long acting reversible contraception. Melbourne: RANZCOG, 2017 (accessed 20 February 2020).
  10. Temple-Smith M, Sanci L. LARCs as first-line contraception - What can general practitioners advise young women? Aust Fam Physician 2017;46:710-5.
  11. Expert Group for Sexual and Reproductive Health. Therapeutic Guidelines: Hormonal contraception 2014. West Melbourne: Therapeutic Guidelines Ltd, 2014 (accessed 18 March 2020).
  12. National Institute for Health and Care Excellence. Long-acting reversible contraception. London, UK: NICE, 2019 (accessed 24 February 2020).
  13. Australian Government Minister for Health. Explanatory Statement – National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019. Canberra: Australian Government Department of Health 2019 (accessed 5 February 2020).
  14. Australian Medicines Handbook. Levonorgestrel IUD. Adelaide AMH Pty Ltd, 2019 (accessed 10 July 2019).