Mifepristone (Oral)

Mifepristone prevents the supply of hormones that maintain the interior of the uterus in order to cause abortion of pregnancy to occur.

Overview

Mifepristone is a medication used in combination with Misoprostol to end a pregnancy by abortion. It can be used in pregnancies up to 70 days in duration but may not be used beyond this period. The medication works by ending the supply of certain hormones that are used to maintain the interior of the uterus and cause the fertilized egg to be released. Without the hormones the contents of the uterus are expelled and the pregnancy cannot be supported by the body.

Mifepristone can also be used to control hyperglycemia in patients suffering from Cushing's syndrome and diabetes. It is used only in patients who have failed in surgery or are not candidates in surgery and there will be complications with fertility in these cases.

This medication is only available when prescribed and is offered as a Korlym or Mifeprex tablet to be taken orally.

Condition treated

  • Unwanted pregnancy

Type Of Medicine

  • Abortive
  • Antiprogestogenic steroid

Side Effects

In addition to the required effects of terminating a pregnancy, Mifepristone can also cause unwanted side effects to occur. While not all of the following side effects may occur, in cases where they do the patient may be required to seek medical attention.

You should consult your doctor immediately if you experience any of the following side effects from the use of Mifepristone:

Occurring less commonly:

  • Unusual tiredness or weakness
  • Excessively heavy vaginal bleeding

Frequency of incidence not known:

  • Unusual or large amount of vaginal bleeding
  • Sweating
  • Sudden increase in stomach or shoulder pain
  • Shortness of breath
  • Pale, cold, or clammy skin
  • Painful or difficult urination
  • Pain or discomfort in the arms, jaw, back or neck
  • Lower back or side pain
  • Fever or chills
  • Fast, weak pulse
  • Cough or hoarseness
  • Confusion
  • Chest pain or discomfort

Other side effects can also occur that may be less serious and will usually abate over time. In most cases these side effects will not require you to seek medical attention but if they are ongoing or become bothersome them you can seek advice from your healthcare professional:

Occurring more commonly:

Occurring less commonly:

  • Unusual bleeding or bruising
  • Troubled breathing, exertional
  • Troubled breathing
  • Trouble sleeping
  • Tightness of the chest
  • Stuffy or runny nose
  • Stomach discomfort, upset, or pain
  • Shaking chills
  • Pale skin
  • Pain or tenderness around the eyes and cheekbones
  • Pain during sexual intercourse
  • Lack or loss of strength
  • Itching of the vagina or genital area
  • Indigestion
  • Increased clear or white vaginal discharge
  • Heartburn
  • Headache
  • Flu-like symptoms
  • Fever
  • Fainting or lightheadedness when rising from a lying or sitting position
  • Cough
  • Belching
  • Anxiety
  • Acid or sour stomach

Other side effects that have not been listed here can also occur in some cases. If you experience any other side effects not listed then you should consult your doctor for advice. If you believe your immediate health to be at risk, however, then you should always contact the emergency services.

Dosage

This medication will always be provided with a medication guide. You must read this and ensure that you understand it fully before you use this treatment. If you have any questions or concerns then you must discuss these with your doctor before proceeding.

When taking the Mifeprex tablets you should note the following:

  • This medication can only be administered by a doctor and you will never be allowed to take it home for use there. The treatment will require you to visit the doctor three times and it is essential that you attend all of these appointments.
  • On the first visit you will be given one tablet of Mifeprex.
  • Two days after this initial visit you will need to attend the doctor again to receive four tablets of misoprostol (another medication that is used in conjunction with this treatment).
  • The final visit takes place two weeks after the first treatment and this is to confirm that the pregnancy has been terminated successfully. You may be given an ultrasound to determine that the pregnancy has ended and to look for any unwanted side effects.
  • The use of this medication will cause bleeding and cramping that will last between 2-4 weeks. If you do not have vaginal bleeding or are experiencing only low levels of bleeding then you must contact your doctor as this may indicate that the treatment is not working.
  • If the treatment is ineffective then you may need to undergo a surgical abortion to completely end the pregnancy. This may also be required if any tissue is left behind following the use of this treatment.
  • If you have an intrauterine device in place in your body then this must be removed before you receive this treatment.

When taking the Korlym version of this medication you should note the following:

  • Your doctor will give you a specific dose and dosing schedule for this medication that you need to follow exactly for best effect. During treatment this dose may be changed a number of times to achieve the right result but you should not ever change the dose yourself. Only ever use this medication as you have been directed to by your doctor.
  • You must swallow this tablet whole and should not ever break or damage it in any way before use.

The dose of this medication will be individual to you and your condition. It will vary depending on the duration of your pregnancy and other personal conditions relating to your health, weight and age. You should only ever use this medication as directed by your doctor and should never allow someone else to use your medication. The following dosage information is a guideline only and should never be used to adjust your dose:

When terminating a pregnancy with a duration of 70 days or less:

  • Adults should take 200mg on the first day. This is followed by 800mcg of misoprostol as a single dose on the third day of treatment. Patients will then need to be examined two weeks later to determine termination.
  • The use of this medication in children is not recommended.

When treating hyperglycemia in patients with Cushing's syndrome:

  • Adults can be treated with 300mg once daily. This dose may be increased as needed but should not ever exceed 1200mg.
  • The use of this medication in children must be determined by the doctor.

When treating hyperglycemia if a dose of this medication is missed then you should take it as soon as possible. If you are close to your next dose, however, then you should skip the dose and return to your normal schedule.

When terminating a pregnancy it is vital that you do not miss a dose of medication or an appointment. If you can't make an appointment you must immediately inform the doctor to rearrange and must attend promptly for the medication to work.

Interactions

Certain medications should never be used in conjunction with one another because they can interact in the body. In some cases reactions may cause severe medical problems and in other medications may stop one another from working effectively. You must inform your doctor of all medications that you are taking before you use Mifepristone for either termination or the treatment of hyperglycemia. This is particularly important if you are taking any of the following medications:

The use of Mifepristone with the following medications is not recommended and your doctor may decide not to treat you with this:

  • Thioridazine
  • Terfenadine
  • Tacrolimus
  • Sparfloxacin
  • Sirolimus
  • Simvastatin
  • Saquinavir
  • Quinidine
  • Posaconazole
  • Pimozide
  • Nelfinavir
  • Mesoridazine
  • Lovastatin
  • Ketoconazole
  • Fluconazole
  • Fentanyl
  • Ergotamine
  • Dronedarone
  • Dihydroergotamine
  • Cyclosporine
  • Cisapride
  • Amisulpride
  • Amifampridine

The use of the following medications is not normally recommended with Mifepristone. You may be prescribed both but the dose or frequency of use may be changed:

  • Zuclopenthixol
  • Ziprasidone
  • Voriconazole
  • Vinflunine
  • Vemurafenib
  • Vardenafil
  • Vandetanib
  • Triptorelin
  • Trimipramine
  • Trifluoperazine
  • Trazodone
  • Toremifene
  • Tetrabenazine
  • Telithromycin
  • Telavancin
  • Telaprevir
  • Sunitinib
  • Sulpiride
  • St John's Wort
  • Sotalol
  • Sorafenib
  • Solifenacin
  • Sodium Phosphate, Monobasic
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate
  • Simeprevir
  • Sevoflurane
  • Salmeterol
  • Ritonavir
  • Rifapentine
  • Rifampin
  • Rifabutin
  • Ranolazine
  • Quinine
  • Quetiapine
  • Protriptyline
  • Propafenone
  • Promethazine
  • Prochlorperazine
  • Procainamide
  • Pitolisant
  • Piperaquine
  • Pimavanserin
  • Phenytoin
  • Phenobarbital
  • Perflutren Lipid Microsphere
  • Pazopanib
  • Pasireotide
  • Panobinostat
  • Paliperidone
  • Ondansetron
  • Olaparib
  • Ofloxacin
  • Octreotide
  • Nortriptyline
  • Norfloxacin
  • Nilotinib
  • Nefazodone
  • Naloxegol
  • Nafarelin
  • Moxifloxacin
  • Metronidazole
  • Methadone
  • Mefloquine
  • Lumefantrine
  • Lopinavir
  • Levofloxacin
  • Leuprolide
  • Lapatinib
  • Ivabradine
  • Itraconazole
  • Indinavir
  • Imipramine
  • Iloperidone
  • Ifosfamide
  • Idelalisib
  • Ibutilide
  • Hydroxyzine
  • Hydroxychloroquine
  • Histrelin
  • Haloperidol
  • Halofantrine
  • Granisetron
  • Goserelin
  • Gonadorelin
  • Gemifloxacin
  • Fosphenytoin
  • Fluoxetine
  • Flecainide
  • Escitalopram
  • Erythromycin
  • Eliglustat
  • Efavirenz
  • Droperidol
  • Doxorubicin Hydrochloride Liposome
  • Doxorubicin
  • Donepezil
  • Domperidone
  • Dolasetron
  • Dofetilide
  • Disopyramide
  • Digoxin
  • Deslorelin
  • Desipramine
  • Delamanid
  • Degarelix
  • Dasatinib
  • Dasabuvir
  • Dabrafenib
  • Crizotinib
  • Conivaptan
  • Cobicistat
  • Clozapine
  • Clomipramine
  • Clarithromycin
  • Citalopram
  • Ciprofloxacin
  • Cilostazol
  • Chlorpromazine
  • Chloroquine
  • Ceritinib
  • Carbamazepine
  • Buserelin
  • Bosutinib
  • Boceprevir
  • Azithromycin
  • Astemizole
  • Asenapine
  • Arsenic Trioxide
  • Aripiprazole
  • Anagrelide
  • Amiodarone

Using Mifepristone with the following medications may increase the risk of side effects occurring. You may be prescribed both but the dose or frequency of use may need to be adjusted.

  • Fluvastatin
  • Alprazolam

Other drug interactions not listed herein can also occur. Ensure that you have informed your doctor of all medications that you are taking before use of this treatment.

You may also be prohibited from using this medication if you have certain medical problems. You must inform your doctor of all medical conditions from which you suffer. This is especially important in the following cases:

Other medical conditions that have not been listed may also affect your use of Mifepristone. Ensure that your doctor is fully aware of all medical conditions from which you suffer before beginning treatment.

Warnings

Before beginning use of this medication you should consider the risks of use and the psychological effects of use in relation to the benefits of use. You should make the decision to use this medication with the doctor having ensured that all of the following factors have been considered:

Allergies ' You must inform your doctor if you have ever had any unusual allergies to any medications in the past. You must also inform them of any other allergies from which you suffer including allergies to dyes, preservatives, animals and foods.

Pediatric ' There are no known limitations to the use of Mifepristone for termination of pregnancy in pregnant women under the age of 17.

The use of Korlym tablets for the treatment of hyperglycemia has not been tested or approved for use in children. Safety and efficiency has not been established.

Geriatric ' The use of Mifeprex tablets for termination have not been tested in the elderly. Elderly patients are, however, more likely to have other medical problems that my cause problems in use. There are no expected limitations to the use of Korlym tablets in the geriatric population.

Pregnancy ' Korlym tablets should not be used during pregnancy. If you are pregnant then you must inform your doctor and you should use appropriate contraceptives to prevent pregnancy during use. If you believe you may have become pregnant during use then you should inform your doctor immediately to seek advice.

Breastfeeding 'The risks of use during breastfeeding are unknown. You should consider the risks of doing so in relation to the benefits with your doctor.

For termination you will need to make three visits to your doctor and it is vital that you attend all three appointments. Missing an appointment can lead to pregnancy continuing and can lead to serious medical complications.

You should not ever take Korlym during pregnancy as it can harm your unborn baby. You should continue to use contraception for at least 1 month following the last dose of this medication.

You should check with your doctor as soon as possible if your vaginal bleeding seems to be severe and lasts longer than expected. If the bleeding soaks through two thick sanitary towels per hour for two consecutive hours then you should contact your doctor.

This medication may need to be followed by surgery to stop excessive vaginal bleeding or to complete a failed termination. You should be prepared for these outcomes before beginning treatment.

Seek immediate medical care if you develop a fever and experience the following symptoms following use:

  • Severe stomach pain
  • Pelvic soreness
  • Weakness
  • Nausea
  • Vomiting
  • Diarrhea
  • Increased heartrate

This medication can cause problems with the adrenal gland to develop. You must contact your doctor if you experience any of the symptoms of adrenal gland problems:

  • Darkening of the skin
  • Diarrhea
  • Lightheadedness
  • Dizziness
  • Fainting
  • Faintness
  • Increased hunger
  • Mental depression
  • Unusual tiredness
  • Mental depression
  • Unusual weakness

Problems with your heart rhythm can occur with the use of this medication. You should be alert to any changes in your heart's patterns and rate and should report any changes to your doctor. You must also inform the doctor before treatment if any members of your family suffer from conditions of the heart.

You should not eat or drink grapefruit when taking this medication as it may increase the dose that is absorbed into the body and increase side effects.

You should not ever take any other medications with this treatment unless they have been discussed with and approved by your doctor. Doing so can put you at serious risk from medication interactions. This includes dietary supplements and herbal remedies too.

Storage

  • Always store this medication out of the reach of children.
  • It can be stored at room temperature out of direct light and away from moisture and heat.
  • Do not keep outdated or unwanted medication for longer than required.

Summary

Mifepristone is used for the termination of pregnancy and for the control of hyperglycemia in patients with Cushing's Syndrome.

When used for termination Mifepristone is used in the form of Mifeprex and is taken in conjunction with Misoprostol. This medication must be taken in the presence of a doctor and the patient will need to attend three appointments with the doctor for the termination to be performed. On the first visit the patient will receive Mifeprex. Two days later the patient will return to receive Misoprostol tablets. Two weeks after this a check up will be performed to confirm that the termination has been successful and to check for unwanted side effects. If the termination is not successful or if excessive bleeding occurs then the patient may need to undergo surgery in order to complete the treatment. Patients should be aware of this and prepared for this eventuality before undergoing the treatment.

When Mifepristone is used for the treatment of hyperglycemia in patients with Cushing's syndrome it is administered as korlym tablets. Patients should not ever use this medication when pregnant and should use effective contraception for at least one month after the last dose is taken to prevent pregnancy from occurring. When used for treatment of hyperglycemia Mifepristone can be taken at home by the patient and they will receive a daily dosing schedule to follow.

This medication will always be issued with a medication guide that explains the processes of treatment as well as the risks of use. It is vital that the patient reads and understands this medication guide before treatment and they must ask the doctor if they have any questions about its use and effects.

Patients should be prepared for the psychological impact of a termination and should consider all of the options available before proceeding. Doctors may suggest counseling before or after this treatment to help with the decision making process.

This medication should never be used for termination of a pregnancy that is longer than 70 days in duration. There is a maximum legal duration of pregnancy that can be terminated and this should never be exceeded. To do so is illegal and both patient and doctor may face prosecution if it occurs.