Description
Mifepristone is used in a regimen together with misoprostol to end a pregnancy that is less than 70 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.
Mifepristone is also used to control high blood sugar (hyperglycemia) caused by high cortisol levels in the blood (hypercortisolism) in patients with Cushing's syndrome who also have type 2 diabetes and have failed surgery or who cannot have surgery.
This medicine is available only with your doctor's prescription and only under a restricted distribution program called Mifepristone REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mifepristone tablets in pregnant women younger than 17 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of mifepristone tablets in the pediatric population. Safety and efficacy have not been established.
Geriatric
No information is available on the relationship of age to the effects of mifepristone tablets in geriatric patients.
Appropriate studies on the relationship of age to the effects of mifepristone tablets have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alprazolam
- Bepridil
- Cisapride
- Colchicine
- Conivaptan
- Cyclosporine
- Deuruxolitinib
- Dihydroergotamine
- Dronedarone
- Eletriptan
- Eplerenone
- Ergotamine
- Fentanyl
- Finerenone
- Flibanserin
- Fluconazole
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Ketoconazole
- Levoketoconazole
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mesoridazine
- Naloxegol
- Pacritinib
- Pimozide
- Piperaquine
- Posaconazole
- Quinidine
- Saquinavir
- Silodosin
- Simvastatin
- Sirolimus
- Sparfloxacin
- Tacrolimus
- Terfenadine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Alfentanil
- Amiodarone
- Amisulpride
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asciminib
- Asenapine
- Astemizole
- Atazanavir
- Avacopan
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Bictegravir
- Boceprevir
- Bosutinib
- Budesonide
- Buprenorphine
- Buserelin
- Capivasertib
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cilostazol
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Cobicistat
- Codeine
- Crizotinib
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amlodipine
- Fluvastatin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal vaginal bleeding, history of or
- Adrenal grand problem, chronic or
- Bleeding problems or
- Ectopic pregnancy (occurs outside the uterus) or
- Endometrial cancer (cancer of the lining of the uterus) or
- Endometrial hyperplasia (changes in the cell lining of the uterus) or
- Porphyria (an enzyme problem)—Should not be used in patients with these conditions.
- Adrenal gland problems or
- Diabetes or
- Heart failure or
- Heart or blood vessel disease (eg, coronary vascular disease) or
- Heart rhythm problem (eg, QT prolongation) or
- Hypertension (high blood pressure) or
- Lung disease or
- Organ transplant—Use with caution. May make these conditions worse.
- Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including bronchial asthma) in patients with this condition.
- Anemia, severe or
- Blood clotting problems or
- Poor blood circulation—Use with caution. This medicine may cause heavy bleeding.
- Hypokalemia (low potassium in the blood)—Should be corrected first before using this medicine.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
For patients using mifepristone tablets for termination of pregnancy:
- It is very important that you understand the requirements of the Mifepristone REMS program, and become familiar with the Mifepristone medication guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the medication guide if you do not have one
- Treatment requires 1 tablet of mifepristone and 4 tablets of a medicine called misoprostol.
- Day One: One 200 milligram (mg) tablet of mifepristone in a single oral dose.
- 24 to 48 hours after taking mifepristone tablet: Four 200 microgram (mcg) tablets (total dose 800 mcg) of misoprostol. Two 200 mcg tablets are placed in each cheek pouch for 30 minutes. Swallow any remaining pieces with water or other liquid.
- This medicine must be taken within 24 to 48 hours after mifepristone; no sooner than 24 hours and no later than 48 hours.
- Most women will expel the pregnancy within 2 to 24 hours of taking misoprostol.
- You must follow up with your doctor 7 to 14 days after the day one dose of mifepristone. Your doctor will check to make sure you are no longer pregnant. It is very important that you go to your follow-up appointment. Call your doctor if you are not able to make your appointment.
- This medicine will cause you to bleed and have cramps for about 2 weeks.
- It is sometimes necessary to have a surgical abortion to completely end the pregnancy. You may also need to have surgery if there is any tissue left in your uterus after treatment with mifepristone.
For patients using mifepristone tablets to control high blood sugar:
- Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
- Swallow the tablet whole. Do not split, crush, or chew it. Take this medicine with food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For termination of pregnancy (70 days or less) taken together with misoprostol:
- Adults and pregnant females age 17 and younger—200 milligrams (mg) as a single dose on Day 1. Followed by 800 micrograms (mcg) (four-200 mcg tablets) of misoprostol 24 to 48 hours later taken as a single dose placed in the cheeks for 30 minutes.
- Children—Use is not recommended.
- For treatment of hyperglycemia in patients with Cushing's syndrome:
- Adults—At first, 300 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 1200 mg per day.
- Children—Use and dose must be determined by your doctor.
- For termination of pregnancy (70 days or less) taken together with misoprostol:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
If you are using this medicine to control high blood sugar, using it while you are pregnant can harm your unborn baby. If you can get pregnant, you must have a negative pregnancy test before starting and before restarting this medicine if you stop taking it for more than 14 days. Use an effective form of birth control (eg, condom, diaphragm, or cervical cap) to keep from getting pregnant during treatment with this medicine and for 1 month after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine together with cyclosporine (Gengraf®, Neoral®, Sandimmune®), dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Ergomar®, Ergostat®), fentanyl (Sublimaze®), lovastatin (Altocor®, Mevacor®), pimozide (Orap®), quinidine (Quinora®), simvastatin (Zocor®), sirolimus (Rapamune®), tacrolimus (Prograf®), or a steroid medicine (eg, dexamethasone, hydrocortisone, methylprednisolone, prednisone, Medrol®). Using these medicines together may cause serious problems.
Do not use this medicine together with a blood thinner, including warfarin (Coumadin®).
Check with your doctor if the vaginal bleeding becomes severe or seems to last longer than expected (eg, soaking through two thick full-size sanitary pads per hour for 2 consecutive hours) while using this medicine.
Check with your doctor right away if you have chills, confusion, dizziness, lightheadedness, fainting, fast heartbeat, fever that lasts for more than 4 hours, lower back or side pain, painful or difficult urination, or rapid, shallow breathing. These maybe a symptoms of serious infection (eg ,sepsis).
This medicine may cause adrenal gland problems. Check with your doctor if you have darkening of the skin, diarrhea, lightheadedness, dizziness, or fainting, increased hunger, mental depression, nausea or vomiting, skin rash, or unusual tiredness or weakness.
Hypokalemia (low potassium in the blood) can occur with this medicine. Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, trouble breathing, or unusual tiredness or weakness.
This medicine can cause changes in heart rhythms, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have fast, pounding, or uneven heartbeats.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Anxiety
- blurred vision
- chills
- cold sweats
- coma
- confusion
- cool, pale skin
- depression
- dizziness
- fast heartbeat
- headache
- increased hunger
- nausea
- nervousness
- nightmares
- seizures
- shakiness
- slurred speech
- swelling
- unusual tiredness or weakness
Less common
- Darkening of the skin
- diarrhea
- dizziness
- excessively heavy vaginal bleeding
- fainting
- loss of appetite
- nausea
- skin rash
- vomiting
Incidence not known
- Chest pain or discomfort
- cough or hoarseness
- fast, weak pulse
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- pain or discomfort in the arms, jaw, back, or neck
- painful or difficult urination
- pale, cold, or clammy skin
- sudden increase in stomach or shoulder pain
- sweating
- trouble breathing
- unusual or large amount of vaginal bleeding
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Back pain
- lack of loss of strength
- stomach pain
Less common
- Acid or sour stomach
- belching
- chest tightness
- cough
- fainting or lightheadedness when getting up suddenly from a lying or sitting position
- flu-like symptoms
- heartburn
- increased clear or white vaginal discharge
- indigestion
- itching of the vagina or genital area
- lack or loss of strength
- pain during sexual intercourse
- pain or tenderness around the eyes and cheekbones
- pale skin
- shaking chills
- stomach discomfort, upset, or pain
- stuffy or runny nose
- trouble sleeping
- unusual bleeding or bruising
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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