Mifepristone (Mifepristone Linepharma) followed by misoprostol (GyMiso) for terminating early pregnancy

Published in Medicine Update

Date published: About this date

Health and medicines information in this article may have changed since the date published. This information does not replace advice from a health professional.

This Medicine Update is for women who are considering medical termination of early pregnancy using mifepristone (RU486) and misoprostol.

This document has been updated since its original release. [Details]

Summary

For terminating pregnancy up to 63 days, without surgery

Mifepristone and misoprostol are two oral medicines (tablets) that can be taken in sequence up to 63 days after your last period as an alternative to surgical termination of a pregnancy.

Mifepristone (also called RU486) has recently been registered for use in Australia. As of 1 February 2015, a composite pack containing both mifepristone and misoprostol is available in Australia through the Pharmaceutical Benefits Scheme (PBS).

How is medical termination different from surgical termination?

  • Medical termination can be used up to 9 weeks of pregnancy, and surgical termination can be used up to 24 weeks (depending on State laws).
  • The failure rate with medical termination is about 7 in 100 women.
  • The failure rate with surgical termination is about 2 in 1000 women.
  • You may experience more bleeding, cramping and abdominal pain during medical termination compared with surgical termination, but the pain can usually be managed with over-the-counter pain relief medicines.
  • There is a small risk of injury to the cervix or uterus with surgical termination, but not with medical termination. There is a lower risk of infection with medical termination.

The decision to choose medical rather than surgical termination is a matter of personal preference in most cases. Discuss the risks and benefits of both methods with your doctor or another trusted health professional before making your decision.

Most of the termination will occur at home

If you choose medical termination, you will take mifepristone first, followed by misoprostol 36–48 hours later.

In most cases — where State and Territory laws permit — misoprostol may be taken at home, but you should have access to a telephone and transport to a hospital or emergency health service in case complications arise. It is recommended that you have a support person to stay with you after taking misoprostol.

Misoprostol must be taken bucally. This means you must keep each tablet between the cheek and gum for 30 minutes before swallowing any remaining fragments with water. Not taking misoprostol in this manner could lead to a higher chance of failure for pregnancies beyond 7 weeks.

After taking misoprostol, you are advised to rest at home for at least 3 hours.

Most women are able to return to their normal daily activities within 2 to 3 days of having a medical termination.

It's essential that you attend the follow-up visits scheduled with your doctor.

Continuing with a pregnancy after a failed medical termination is not advised. Always seek medical advice if you have any concerns that the medical termination has not been successful. Follow-up surgical termination may be necessary.

Who can prescribe mifepristone and misoprostol?

These medicines can only be prescribed by doctors who have had specific training and who are registered with MS Health.

Medical specialists in obstetrics or gynaecology who have registered with MS Health may also prescribe these two medicines.

Talk to your doctor or other trusted health professional if you think that mifepristone and misoprostol might be an option for you. Alternatively, you can find a doctor who is registered to prescribe these two medicines by contacting your nearest sexual health and family planning clinic, a Marie Stopes International clinic or MS Health.

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What are mifepristone and misoprostol?

Mifepristone and misoprostol are two oral medicines (tablets) that, when taken in the correct sequence, cause the termination of pregnancy (abortion). This is also called 'medical termination' of pregnancy, and is different from 'surgical termination'.

Mifepristone

The active ingredient in this medicine is mifepristone (pronounced mi-fe-PRIS-tone).

It is also known by the brand name Mifepristone Linepharma.

Mifepristone is sometimes referred to as RU486 or the 'abortion pill'; however, this medicine should not be taken by itself, and has to be followed by misoprostol to terminate a pregnancy.

Misoprostol

The active ingredient in this medicine is misoprostol (pronounced miso-PROS-tol).

It is also known by the brand name GyMiso.

The active ingredient is the chemical in the medicine that makes it work. Read more about active ingredients.

Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines are available under several different brand names.

You can find the active ingredient in your medicine by entering the brand name in the NPS Medicine Finder. You can also find brand names if you enter the active ingredient.

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What do these medicines do?

Mifepristone

This medicine interferes with the body's use of progesterone — a key hormone for maintaining a pregnancy.

When it is taken as the first step in this sequence of two medicines, mifepristone starts the medical termination by:

  • relaxing and opening the cervix (the neck of the womb)
  • making the uterus (womb) sensitive to hormones called prostaglandins, which are responsible for starting contractions.

Misoprostol

This medicine mimics the natural hormones (prostaglandins) produced by the body, which are responsible for starting contractions. When it is taken as the second step in this sequence of two medicines, misoprostol continues the process of medical termination by:

  • further relaxing and opening the cervix
  • causing contractions of the uterus so that its contents are expelled through the vagina.

Read more about the effects of these two medicines on the body.

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Who can take mifepristone/misoprostol?

Mifepristone and misoprostol are available on the PBS and approved for use in women who are seeking to terminate a pregnancy, are no more than 9 weeks pregnant (i.e. it has been no more than 63 days since your last period), and who would like an alternative to surgical termination.

To use these medicines, you will need to:

  • have a medical examination (usually including an ultrasound) to confirm that your pregnancy is 9 weeks or less and to exclude the possibility of an ectopic pregnancy (a pregnancy occurring outside the uterus, e.g. in the fallopian tubes)
  • follow through with all required doses, rest, and clinic attendance, including follow-up visits
  • have access to a telephone and transport to a medical facility in case of emergency. It is also preferable to have a support person with you after taking the second medicine (misoprostol)
  • be prepared to undergo a surgical termination if the effect of mifepristone/misoprostol is incomplete or unsuccessful. Up to 7 in 100 medical terminations are unsuccessful, and follow-up surgical termination may be needed.

Talk with your health professional about all the options for terminating a pregnancy.

Who can't take mifepristone/misoprostol?

You should not take these medicines if one or more of the following apply:

  • your pregnancy has not been confirmed by a medical examination (usually including an ultrasound) or if there is uncertainty about whether your pregnancy is 9 weeks or less
  • your doctor suspects an ectopic pregnancy
  • you have an intrauterine device (IUD or 'coil') in place
  • you are breastfeeding
  • you've had an allergic reaction to mifepristone or misoprostol in the past.

These medicines may not be suitable for you if one or more of the following apply:

  • you have certain bleeding disorders or problems with your adrenal glands
  • you are already taking regular corticosteroid medicines (e.g. preventer medicines for asthma, such as fluticasone or budesonide inhalers)
  • you are taking an anticoagulant medicine (e.g. warfarin, rivaroxaban).

Talk to your doctor if you aren't sure whether you should take mifepristone/misoprostol.

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Where is mifepristone/misoprostol available?

Mifepristone and misoprostol can be prescribed by:

  • doctors who have completed training and registered with MS Health
  • specialists in obstetrics or gynaecology who have registered with MS Health.

Mifepristone/misoprostol can be dispensed by a pharmacy that has registered with MS Health.

Medical termination with these medicines is legally available throughout Australia, but the conditions and restrictions on performing the procedure may vary depending on the legislation of each State or Territory. Your doctor will provide information relevant to where you live.

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How to take mifepristone/misoprostol — the dosing process

Day 1: Mifepristone

You will be given 1 mifepristone 200 milligram (mg) tablet, which you will be asked to swallow with water in the presence of your doctor at the surgery or clinic.

What to expect

Vaginal bleeding — similar to a menstrual period — will usually start 1 to 2 days after taking mifepristone, although some women may start bleeding earlier than this. In most cases, bleeding at this stage can be managed with regular sanitary pads.

A small number of women (around 3 in 100) will have a complete termination at this stage, before they take the misoprostol tablets. A complete termination happens when the embryo and placenta have been expelled from the uterus and out through the vagina with any blood. If you suspect that this has happened to you, return to your doctor immediately for a follow-up examination so that the possibility of complications can be ruled out.

Many women are able to continue with their usual daily activities during this time. However, depending on the way this medicine affects you (i.e. if you experience nausea or vomiting as a side effect of mifepristone), you may feel like resting.

After 36–48 hours: Misoprostol

You will need to take misoprostol 36–48 hours after taking mifepristone. The usual dose is 800 micrograms (4 tablets) of misoprostol.

Misoprostol must be taken bucally. This means you must keep each tablet between the cheek and gum for 30 minutes before swallowing any remaining fragments with water. Not taking misoprostol in this manner could lead to a higher chance of failure for pregnancies beyond 7 weeks.

There are a few different ways of taking this medicine; your doctor will provide advice about how you should take it. For example, you can take all 4 misoprostol tablets at once, or you can take them in two separate lots of 2 tablets, 2 hours apart.

Contact your doctor immediately if you have forgotten to take your misoprostol and it is more than 48 hours after you have taken mifepristone.

What to expect

Your doctor will give you written information about the medical termination process, including what to expect. You will also be given information about what to do, where to go, who to contact if you have any concerns or you experience any complications, and which side effects and symptoms you need to report to the doctor.

After taking mifepristone, vaginal bleeding will start (if it hasn't already) or reach its heaviest at this stage and will be accompanied by cramps or abdominal pain. This is when the embryo is expelled from the uterus. Most women are very aware when this has happened. You may notice clotting or small pieces of tissue but you are unlikely to recognise the embryo, as it is less than 2 cm long at this stage. You should stay at home and rest until this process is complete.

The termination will be complete when the embryo, placenta and all accompanying blood and tissue are expelled from the uterus. This will usually take place within 4 hours of taking the misoprostol and usually takes about 30 minutes.

Bleeding

Bleeding can usually be managed with sanitary pads designed for heavy flow (e.g. thicker 'overnight' pads). You may need to change them frequently for a day or so. If this is not adequate, or if you continue to bleed heavily for more than 2 days, talk to your doctor.

Managing pain

Pain due to abdominal cramping and contractions can usually be managed with over-the-counter (OTC) pain relief medicines (e.g. ibuprofen, paracetamol with codeine, naproxen). Discuss pain relief with your doctor before taking mifepristone/misoprostol, and talk to your doctor again if you feel your pain is not being controlled by OTC pain medicines during the medical termination.

Support and assistance

It is important for you to have a support person who has also been informed about the medical termination process and who can stay with you until the termination is complete. Your support person should know exactly who to contact in an emergency and how to contact them. You should choose emergency services that you would be comfortable attending (e.g. which particular doctor or hospital emergency department) if you need to do so.

Alternatively, you may choose to be at a clinic for this part of the process. Talk to your health professional about your options and your preference.

Days 14–21: Follow-up examination

It's essential that you return to your doctor for a follow-up examination 14–21 days after taking the first medicine (mifepristone) to ensure the termination is complete and that there are no complications. Some doctors may ask you to return for a follow-up examination sooner than this.

What to expect

Your doctor may examine you, and take blood samples for testing, or conduct an ultrasound. A formal medical follow-up is essential because if the medical termination is not complete, it can result in serious, sometimes life-threatening complications such as infection.

If you notice any signs that concern you or that may indicate a complication at any time during your medical termination, you should see your doctor immediately, or go to your nearest emergency department.

Your follow-up visit is a good time to ask your health professional about your options for ongoing contraception and about resuming sexual activity.

Talk to your health professional if you have concerns about how to take these medicines.

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Important side effects to consider

The side effects of mifepristone and misprostol are similar, but misoprostol is more likely than mifepristone to cause nausea, vomiting, diarrhoea and headache. After taking these medicines, you may experience one or more of the common or very common side effects listed below, or you may not experience any of them:

  • nausea
  • vomiting
  • diarrhoea
  • dizziness
  • abdominal cramps, pain or discomfort
  • headache
  • fatigue
  • chills and fever (a temperature of 37.5°C or higher)
  • fainting
  • breast tenderness
  • hot flushes, skin rashes or itching.

Talk to your health professional about possible side effects from these medicines before taking them.

If any of these side effects — or any other unexpected effects — concern you during the medical termination process, speak to your health professional.

Vaginal bleeding and abdominal pain and cramping are the expected effects of these medicines and, although unpleasant, they indicate that the termination is progressing as it should.

If you don't experience vaginal bleeding, abdominal cramps and contractions of the uterus within 4 hours of taking misoprostol (the second medicine), this may indicate that the medical termination has failed. If this happens to you, visit a doctor urgently.

Signs of more-serious complications

If you experience a serious complication, you should be prepared and willing to access emergency medical help.

The following serious complications have been known to occur after termination of pregnancy with mifepristone/misprostol.

Persistent bleeding

Vaginal bleeding that is not heavy can continue for 10–16 days after a medical termination. If you continue to have bleeding after this, or if you are concerned about the amount or nature of bleeding at any time after having a medical termination, see your doctor.

If you experience heavy vaginal bleeding for more than 2 days after a medical termination, see a health professional immediately. Up to 4 in 1000 women will experience severe bleeding that requires a blood transfusion.

Infection

Infection of the organs or tissues in the pelvic region is an uncommon but serious complication that may occur in fewer than 1 in 100 women after a medical termination. If you have an infection, you may have some or all of the following symptoms:

  • fever (37.5°C or higher)
  • malaise (generally feeling unwell)
  • lethargy
  • nausea
  • vomiting
  • persistent abdominal pain or tenderness
  • offensive-smelling vaginal discharge.

Failure of the procedure

There is a chance (about 7 in 100 women) that taking mifepristone/misoprostol will not result in a successful termination of pregnancy. About 2 in every 100 of these women will need further medicines prescribed by their doctor to complete the termination, and about 5 in every 100 women will need to have a surgical termination if the medical termination fails.

Not taking misoprostol bucally, as instructed by your doctor, could lead to a higher chance of failure for pregnancies beyond 7 weeks.

Continuing with a pregnancy if the medical termination has failed is strongly not advised because the developing embryo may have been harmed or deformed.

Unsuccessful termination can also lead to serious complications, so it's important to get medical help urgently if you think this has happened. Ongoing bleeding, with or without signs of an infection, may suggest an unsuccessful termination. However, it's essential to have a follow-up visit with your doctor 14–21 days after the treatment — or sooner if requested by your doctor — even if you don't have any signs of a complication.

Visit your doctor, go to your nearest emergency department, or call for an ambulance if you experience any of the symptoms of serious complications described above during or after your medical termination.
For a more-complete list of possible side effects, see the consumer medicine information (CMI) for Mifepristone Linepharma (mifepristone) and for GyMiso (misoprostol), available from your doctor, MS Health or through the NPS Medicine Finder.

If a side effect is described as very common, this means that in clinical trials at least 10 out of 100 people experienced that side effect.

If a side effect is described as common, this means that in clinical trials, more than 1, but fewer than 10 out of 100 people experienced that side effect.

A clinical trial is a research study conducted with patients that compares one treatment with one or more other treatments, to assess its effectiveness and safety.

Ask your health professional about the possible side effects of a medicine before you take it. Always tell your health professional about any changes to your condition.

If you have a question about the side effects of your medicine call Medicines Line on 1300 MEDICINE (1300 633 424). To report possible side effects call the Adverse Medicine Events (AME) Line on 1300 134 237. Both these services are available Monday to Friday, 9am to 5pm AEST.

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What else you should know about mifepristone/misoprostol

Mifepristone and corticosteroids

Mifepristone (the first medicine) may reduce the effect of any inhaled or oral corticosteroid medicines for up to 4 days after taking it.

Tell your health professional if you are taking any corticosteroid medicines (e.g. fluticasone or budesonide inhalers, which are used to prevent and treat asthma) and are planning a medical termination. Your health professional may consider temporarily increasing your dose of corticosteroids and monitoring you carefully, or they may advise against medical termination.

An interaction is when another medicine, food or drink (including alcohol) changes how well a medicine works, or changes its side effects in some way. The interaction may be with a food or food supplement, another prescription or over-the-counter medicine, or a natural or herbal remedy.

Use a medicines list to help keep track of the medicines you are taking. Take it with you each time you visit your health professional, or if you go into hospital. The NPS Medicines List is available for order, print or download and as a smartphone app.

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How to decide between medical and surgical termination

Surgical termination of pregnancy

Surgical termination of pregnancy (abortion) is another option for women who are considering a medical termination. You will need to compare both options before making your decision. You may find it helpful to talk this decision through with your health professional.

Surgical termination is generally performed as a 'day procedure', after a doctor has assessed you, and your pregnancy has been confirmed by an ultrasound scan. The procedure is usually performed after you have been given a sedative, making you calm, relaxed and sleepy, but a general anaesthetic may be used if necessary. In most cases, gentle suction is then used to perform the procedure.

Medical termination with mifepristone/misoprostol Surgical termination
Advantages/benefits
  • no surgery or anaesthetic involved
  • no risk of injury to the cervix or uterus
  • most of the termination can take place at home
  • lower risk of infection compared with surgical termination.
  • can be used up 24 weeks of pregnancy (depending on State laws)
  • quicker procedure compared with medical termination
  • takes place in a clinic or hospital
  • you are less aware of the procedure
  • generally less bleeding compared with medical termination.
Disadvantages/risks
  • can't be used for women who are more than 9 weeks pregnant
  • bleeding, cramps, and some pain, and possibly side effects such as nausea and diarrhoea
  • medical termination fails in about 7 in 100 women, and you may need to have a surgical termination
  • you will need to make more than one visit to the clinic or doctor.
  • an invasive procedure
  • small risk of injury to the cervix or uterus
  • risk of post-operative infection
  • possible side effects from the anaesthetic
  • surgical termination fails in about 2 in 1000 women.

Research has not shown any link between terminating a pregnancy — either medically or surgically — and future infertility, ectopic pregnancy or breast cancer.

It is not known whether having a medical or surgical termination increases your chance of having a miscarriage, preterm birth, or other complications with future pregnancies.

Recovery time is similar in both methods, and most women are able to return to their normal daily activities within 2–3 days of either a medical or a surgical termination. However, this doesn't include the 36–48 hours between taking the first and second medicine in the case of medical termination, making a medical termination a longer process overall.

Your health professional will advise you of the risks and benefits of both medical and surgical termination. You should consider which option is best for you. Apart from the advantages and disadvantages described in the table above, you may have personal preferences such as:

  • being at home during most of the medical termination or having a procedure in a clinic or hospital
  • having a procedure under sedation or anaesthetic versus managing your own pain relief
  • managing the bleeding at home.

The decision to choose a medical or a surgical termination is an individual one. Discuss your options and the advantages and disadvantages of each method with your health professional before making a choice that best suits you.

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Mifepristone and misoprostol are PBS listed

Mifepristone and misoprostol are listed on the Pharmaceutical Benefits Scheme (PBS) in Australia for medically terminating pregnancy up to 63 days (9 weeks), making them available to eligible women at a reduced cost. However, there are still restrictions on the availability of these medicines in Australia, meaning that they can't be prescribed by every doctor, nor can they be dispensed by every pharmacy.

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Find out more about terminating pregnancy and other pregnancy and contraceptive options

To discuss your options regarding terminating a pregnancy, contraception, or other pregnancy and fertility issues, you can contact:

  • your doctor (or another trusted health professional if you prefer)
  • your nearest Women's Health Centre (centres in NSW, QLD, SA, TAS, VIC, WA).

Marie Stopes International

The Marie Stopes organisation — incorporating the Dr Marie Clinics and MS Health — is a not-for-profit organisation that specialises in providing sexual and reproductive health information and services, including confidential counselling, surgical and medical termination and 24-hour aftercare.

MS Health

MS Health (a not-for-profit pharmaceutical company; part of Marie Stopes International) is the supplier of mifepristone (Mifepristone Linepharma) and misoprostol (GyMiso) in Australia. It is responsible for providing training for doctors who wish to prescribe these medicines and also for keeping a register of the doctors and pharmacists who are authorised to prescribe and dispense them.

  • MS Health (licensee of mifepristone/misoprostol in Australia).

Sexual Health and Family Planning clinics

Not-for-profit sexual health and family planning organisations provide information, confidential counselling and support for women about their sexual health, reproduction, contraception and terminating a pregnancy, and the possible alternatives.

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Where to find more information about mifepristone and misoprostol

Read the consumer medicine information (CMI) for mifepristone and misoprostol for important details about:

  • who should not use the medicines
  • how to take the medicines
  • most of the possible side effects
  • other ingredients.

You can get the CMI for mifepristone and for misoprostol from:

  • NPS Medicinewise
  • MS Health, the licencee of mifepristone and misoprostol in Australia (or phone 1300 515 883)
  • your doctor or pharmacist.

Information over the phone

NPS MedicineWise works with healthdirect Australia to provide consumers with information on medicines.

To get information about Mifepristone Linepharma (mifepristone) or GyMiso (misoprostol) call the NPS Medicines Line on 1300 MEDICINE (1300 633 424) from anywhere in Australia. Service is available Monday–Friday, 9am–5pm EST except NSW public holidays.

To report a side effect with mifepristone and/or misoprostol

Call the Adverse Medicines Event (AME) Line on 1300 134 237 (Monday–Friday, 9am–5pm EST).

The AME Line lets you report and discuss side effects that might be related to your medicine. Medicine-related side effects are then reported to the Therapeutic Goods Administration (TGA) for assessment and contribute to national medicine safety efforts. Your personal information will remain confidential and your privacy maintained.


More about using medicines wisely

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Revision history

Updated February 2015 to reflect changes to the PBS listing.

First release: September 2013.

References