MIFEPRISTONE

Drugs in Pregnancy and Lactation.

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Name: MIFEPRISTONE
Class: Antiprogestogen
Risk Factor:    X

Fetal Risk Summary

Mifepristone (RU 38486; RU 486) is an orally active, synthetic antiprogestogen that has been primarily used for the termination of pregnancy. At higher doses, the drug also has antiglucocorticoid effects. The mechanism of action of mifepristone, which exerts its antiprogestogen effect at the level of the receptor, and the physiologic effects it produces in both animals and humans have been studied and reviewed in a number of References (1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 and 16). A 1993 review summarized the drug's antiprogestin and other pharmacologic effects in humans (17).

Mifepristone rapidly crosses the placenta to the fetus in both monkeys (18) and humans (19,20). The fetal:maternal ratio decreased from 0.31 to 0.18 in monkeys between the 2nd and 3rd trimesters (18). In 13 women undergoing 2nd-trimester abortions, a single 100-mg oral dose produced fetal cord blood concentrations of mifepristone ranging from 20 ng/mL (30 minutes) to 400 ng/mL (18 hours) (19). The peak maternal concentration (1500 ng/mL) was attained in 1–2 hours, and the average fetal:maternal ratio was approximately 0.33. In contrast to a simple diffusion process observed in monkeys (18), an active transport mechanism was suggested because the fetal concentration increased exponentially (19). In the second human study, a lower mean fetal:maternal ratio (0.11) was measured at 17.2 ± 8.6 hours in six women treated with 600 mg of mifepristone for 2nd-trimester abortion (20). Maternal plasma concentrations of aldosterone, progesterone, estradiol, or cortisol did not change significantly 4 hours after mifepristone, but a significant increase in fetal aldosterone occurred at this time, rising from 999 pmol/L to 1699 pmol/L. Mean changes in the fetal levels of the other three steroids were not significant.

A large number of studies have investigated the use of mifepristone as an abortive agent, either when given alone (21,22,23,24,25,26,27,28,29,30,31,32,33,34,35 and 36), or when combined with a prostaglandin analogue (24,30,37,38,39,40,41,42,43,44,45,46,47,48,49,50 and 51). The drug has also been studied for labor induction after 2nd trimester intrauterine death (52,53), as a cervical ripening agent in the 1st trimester (54,55,56,57,58 and 59), in the 2nd trimester (60), and at term (61,62 and 63). Although mifepristone, especially when combined with a prostaglandin analogue, is an effective abortive agent, it has not been effective when used for the termination of ectopic pregnancies (64,65). The use of mifepristone as a postcoital contraceptive or for routine administration during the mid to late luteal phase to prevent a potential early pregnancy by induction of menses (i.e., contragestation) has also been frequently investigated (22,66,67,68,69,70,71,72,73,74,75,76,77,78 and 79).

Mifepristone is teratogenic in rabbits, and the effect is both dose and duration dependent (80). Abnormalities observed included growth retardation, nonfused eyelids and large fontanelle, opened cranial vault with exposure of the meninges and hemorrhagic or necrotic nervous tissue, necrotic destruction of the upper part of the head and brain, and absence of closure of the vertebral canal (80). At doses approximating those used in clinical practice, no evidence of teratogenicity was observed in postimplantation rat embryos exposed to mifepristone in culture (81). Similarly, no teratogenicity was observed after in vitro exposure of monkey embryos to mifepristone (82,83).

In humans, only six cases have been reported of exposure to mifepristone that was not followed by subsequent abortion. Although specific details were not provided, in the United Kingdom Multicenter Trial (gestational age <36–69 days from last menstrual period), one woman changed her mind after taking mifepristone and her pregnancy continued until a normal infant was delivered at term (41). In 1989, brief mention was made of fetal malformations discovered after pregnancy termination at 18 weeks' gestation (84). Additional information on this and one other case was published in 1991 (85,86 and 87). A 25-year-old primigravida was treated with 600 mg of mifepristone at 5 weeks' gestation, but then decided not to proceed with termination (85,86). Severe malformations were observed by ultrasound examination at 17 weeks' gestation, consisting of an absence of amniotic sac, stomach, gallbladder, and urinary tract, and the pregnancy was stopped with prostaglandin at 18 weeks (85). The 190-g fetus had typical features of the sirenomelia sequence (sympodia; caudal regression syndrome): fused lower limbs with a single flexed foot containing seven toes, no external genitalia or anal or urethral openings, and absence of internal reproductive organs, lower urinary tract, and kidneys. Other anomalies were hypoplastic lungs, a cleft palate, and a cleft lip. Sirenomelia is thought to date back to the primitive streak stage during the 3rd week of gestation, and, thus, in this case, before exposure to mifepristone (85). However, induction of cleft palate and cleft lip occurs at approximately 36 days of gestation (85) and may have been a consequence of drug exposure.

A normal outcome was achieved in the second case in which a 30-year-old woman was treated with 400 mg of mifepristone 6 weeks after her last menstrual period, but then decided to continue her pregnancy (85). She eventually delivered a healthy, 3030-g male baby at 41 weeks' gestation. Three other normal infants have been described after in utero exposure to mifepristone (59,88). All three were participants in clinical trials who decided to continue their pregnancies after treatment with mifepristone at 8, 8, and 9 weeks' gestation (88). The latter patient vomited 1.5 hours after taking the drug and reported seeing at least one partially digested tablet in the vomit. Delivery occurred at 40 weeks (4150-g male), 39 weeks (3930-g male), and 41 weeks (3585 g-female), respectively. Follow-ups of the infants at 15, 9, and 6 months, respectively, were completely normal.

In summary, mifepristone (RU 486) is a potent antiprogestogen compound that is mainly used for the termination of pregnancy, usually in combination with a prostaglandin agent. It has also been used for cervical ripening before abortion and is currently being studied as an aid in the induction of labor at term. It is teratogenic in one animal species, but not in two others, one of which is a primate species. Data are too limited to determine whether the drug is a human teratogen. Because the incidence of successful abortion after mifepristone is high, but not total, women should be informed of the risk for embryotoxicity if their pregnancy continues after use of this drug.

Breast Feeding Summary

No data have been located on the excretion of mifepristone in breast milk. Since the drug is well absorbed after oral administration, it should not be used during breast feeding because of its potent antihormonal effects. However, as a result of the limited indications for this agent, the opportunities for its use during lactation should be infrequent.

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References

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Index

Q&A about Mifepristone

Lacey J
Mifepristone?
My brother's girlfriend thinks she may be pregnant but doesn't want to have the baby. Or rather can't for health safety issues. Her doctor mentioned something to her about mifepristone. However; this pill can run really expensive for those of you that don't know. Does anyone know if there is an over the counter she can take instead?
Kelsey H
No, RU-486 (mifeprestone) is the only thing out there. If it is for health issues, a surgical abortion is probably better anyway, because there's less risk that the abortion will be incomplete.

I'm sorry for her loss.
Miss M
How do I get mifepristone without consulting my parents? and how much do they cost?
I'm scared that I might be pregnant. I'm still young and I belong to a respected family. I don't want to humiliate my parents, nor do I want to ruin my boyfriend's life.

If I am pregnant, I'm considering abortion. But how do I do it on my own? I mean, I don't have alot of money and I'm scared to ask an adult about it.

Any suggestions on how I can have an abortion and not let my parents find out? Because we are also Catholic and it is considered a great sin to do so... but I still don't want to pull through this if I am pregnant.
iamabeet...
You need to tell your Mother.

I agree with the other people about the fact that you have decided to have sex and even if it was protected, you have to deal with the concequences of the protection not working.

The other thing to is that if you have an abortion and you have complications after that then your Mother will freak when she has to take you to the Hospital not fully knowing what you have done.

Having an abortion is up to you - ultimately it's your body but, you should discuss this with your boyfriend firstly - it's also his Child. He may have different views to you and he may want to support you through whatever it is you decide to do.

The other thing - it's 2006! We're not in the early 1900's anymore. This is something that is happening EVERY day. Don't worry about shaming your parents. They are the ones who should be ashamed for not educating you in the correct way for this sort of stuff to be prevented let alone for you not to feel that you are able to discuss something like this with them.

Good luck - whatever your decision may be xoxo
J
Where can I get mifepristone in the UK?
Do I need to consult a doctor and have it prescribed to me or can I just get it over the counter at a pharmacist?

Also what will happen after I take it?

Please help, don't judge.
frangipa...
Should not be a problem but usually only available at hospitals.
needingh...
Where can I get Mifepristone treatment in or around Topeka Kansas?
I was in an abusive relationship and I've discovered I'm pregnant. I'm afraid that if he finds out I'm pregnant he'll come after me and might hurt the child if I were to have it.
aly t
Jraz R
Has anyone ever had any experience with Mifepristone and Misoprostol?
I would like to know how these drugs worked for you!
Natscan
I am currently taking it to bring on expulsion of a missed miscarriage - which has been dead inside me for 3 weeks. I had four tablets inserted today at 1:30 at the hospital. (they must have been designed by a man because they have corners - OUCH! hexagons!??? I ask you! - Why oh Why?) (technically 9 weeks 1 day pregnant and very very sad about this whole situation)

i took pain killers at 3pm because i felt some cramping coming on. at 4:30 my legs got weak and i became cold, clammy, sweaty, and dizzy. hubby said i looked like i was strung out on drugs. i felt like i was on BAD ecstasy.

I felt like my bowels wanted to move but they wouldn't. I felt like i wanted to vomit but i couldn't. I sat on the loo for an hour with a bucket in front of me and rocked (it helps) with a hot water bottle. the pain was the WORST I've ever felt (and i've been bitten by a redback spider - previously #1 on the most painful list, followed by a natural miscarriage - but that was ten years ago so i may have forgotten how bad that ACTUALLY was). I noticed that breathing like i was in labour and sucking on ice cubes helped a whole lot.

at 5:30 i fell asleep for 10 minutes (on the loo) and when i woke i felt fine. Cramps gone. Ten minutes before I'm allowed to take more codeine pain comes back but I'm strict with myself. at 11pm i started bleeding (big time!) right on schedule. The pain is not so bad and I'm glad I'm at home and i didn't choose something invasive that could damage my uterus.

UPDATE: 5 hours since bleeding started, haven't had another pain reliever and haven't needed one although i might in a bit. I can't sleep, not sure i want to, i just want to monitor. Cramps gone and put hot water bottle away (maybe just for now but we'll see). Still lots of blood...i have never seen so much!

I DEFINITELY think i made the right choice now.
Enquirer
i took mifepristone at 17 weeks and decided to continue with the pregnancy, will my baby be ok?
Will baby have any deformities, defects, abnormalities, disabilities or mental problems?
**You must be kidding**
Yahoo is definitely not the place to receive an answer for a question of this magnitude. I urge you to please visit your ob/gyn or even a planned parenthood. They all will be able to monitor your baby and find out if all is safe or not. 17 weeks was exceptionally late to take the mifepristone, if anyone does take it (which I most certainly do not encourage) it should not be taken after 8 weeks. Goodness gracious sweetheart, go to the doctor immediately. If you call and explain the situation, you will most likely get in TODAY.
Manju
Side effects of Mifepristone - Abortion pill?
Hi. I have taken Mifepristone on 21st May and Misoprostol on 23rd May for stopping pregnancy. After taking Misoprostol, i got heavy bleeding and now its decreased. Bleeding is like normal periods now. I am observing decrease in my breast size. This is bothering more. Is this happening because of that medicine? Is this any side effect and why is it happening?

Two days back i felt burning sensation in my stomach. It is decreased now. Please help me out.
trezce
how many month or weeks are you pregnant?

The decrease in breast size may not be actually so, but it might be just going back to its original size before pregnancy occurred. Pregnancy may increase your breast size.

One more thing didn't you know that those drugs are not indicated for abortion but for ulcers.

What you did was very dangerous.

Please consult your doctor if you experience heavy bleeding and pain. Such symptoms might be of incomplete abortion. Then again, those drugs are dangerous if used in such a way. Please try to go to your doctor.
sarah
Has anyone tried this product Mifepristone?
Has anyone tried this product Mifepristone? If so can anyone HONESTLY tell me what the side effects are and what happens when this product is taken? Im just wondering! And will Plan B stop a pregency for going in futher.
aaaime
Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

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What is mifepristone?

Mifepristone blocks the actions of the naturally occurring hormone progesterone, which is necessary for pregnancy to continue.

When used together with another medicine called misoprostol, mifepristone is used to end an early pregnancy.

Mifepristone may also be used for purposes other than those listed in this medication guide.

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What should I discuss with my healthcare provider before taking mifepristone?

Do not take mifepristone if

it has been more than 49 days (7 weeks) since your last menstrual period began;

you have an IUD;

your healthcare provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy);

you have problems with your adrenal glands (chronic adrenal failure);

you take a medicine such as warfarin (Coumadin) to thin your blood;

you have a bleeding problem;

you take certain steroid medicines:

you cannot return for the next 2 visits;

you cannot easily get emergency medical help in the 2 weeks after you take mifepristone; or

you are allergic to medicines that contain misoprostol, such as Cytotec or Arthrotec.

Before taking mifepristone, tell your healthcare provider about any other medical conditions that you have and if you smoke 10 or more cigarettes a day. You may not be able to take mifepristone, or you may require special monitoring during treatment.

Mifepristone is in the FDA pregnancy category X. This means that mifepristone is known to cause birth defects in an unborn baby. Mifepristone treatment that does not end in termination of pregnancy may cause birth defects in the unborn baby.

It is not known whether mifepristone passes into breast milk. Do not take mifepristone without first talking to your doctor if you are breast-feeding a baby.

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How should I take mifepristone?

Take mifepristone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

On Day 1 at your healthcare provider's office, you will read the Medication Guide for mifepristone and discuss the benefits and risks of using mifepristone. If you decide that mifepristone is right for you, you will sign the Patient Agreement then, after getting a physical exam, swallow 3 tablets of mifepristone.

When you return to your healthcare provider's office on Day 3, your healthcare provider will check to see if you are still pregnant. If you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may send you home with medicines for these symptoms.

About Day 14 (2 weeks after you took mifepristone), you will return to your healthcare provider's office to be sure you are well and that you are not pregnant. Your healthcare provider will check to see whether the pregnancy has completely ended. If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

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What happens if I miss a dose?

Your doctor will administer mifepristone, so you will not miss a dose.

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What happens if I overdose?

An overdose of mifepristone is unlikely to threaten life and is unlikely to occur since the tablets are administered at your doctor's office.

Symptoms of a mifepristone overdose are not known.

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What should I avoid while taking mifepristone?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

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What are the possible side effects of mifepristone?

Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

Other less serious side effects may include:

diarrhea, nausea, vomiting;

headache or dizziness;

back pain; or

tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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What other drugs will affect mifepristone?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

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Where can I get more information?

Your pharmacist has additional information about mifepristone written for health professionals that you may read.

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What does my medication look like?

Mifepristone is available with a prescription under the brand name Mifeprex. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

Mifeprex 200 mg-light yellow, cylindrical tablets

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 3.03. Revision date: 2/13/04.

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