Korlym(TM): Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment or if treatment is interrupted for more than 14 days in females of reproductive potential. Pregnancy should be prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization .Oral route(Tablet)
Mifeprex(R): Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following mifepristone use. Atypical Presentation of Infection: Patients with serious bacterial infections and sepsis can present without fever, bacteremia or significant findings on pelvic examination; use a high index of suspicion to rule out serious infection and sepsis. Bleeding: Prolonged heavy bleeding may be a sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed. Mifepristone is only available through a restricted program called the MIFEPREX REMS Program. Before prescribing mifepristone, advise the patient about these serious risks, ensure that she knows what to do if she experiences symptoms of these events, and discuss the medication guide and the patient agreement with her .
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) in patients with Cushing's syndrome who also have type 2 diabetes and have failed surgery or are not candidates for surgery.
This medicine is available only with your doctor's prescription.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Mifeprex® 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 Korlym™ tablets in the pediatric population. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of Mifeprex® tablets in geriatric patients.
Although appropriate studies on the relationship of age to the effects of Korlym™ tablets have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
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.
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.
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.
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.
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:
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
For patients using Mifeprex® tablets:
For patients using Korlym™ tablets:
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.
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.
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.
You must have 3 visits to your doctor's office during treatment with Mifeprex®. It is extremely important that you attend all 3 visits.
Using Korlym™ while you are pregnant can harm your unborn baby. Use an effective form of birth control (eg, a condom, a diaphragm, or a cervical cap) to keep from getting pregnant during therapy and for 1 month after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Do not use this medicine if you are also using 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 (such as dexamethasone, hydrocortisone, methylprednisolone, prednisone, Medrol®). Using these medicines together may cause serious problems.
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.
You may need to have a surgical procedure to stop excessive vaginal bleeding or to terminate a pregnancy that was not terminated with the Mifeprex® treatment procedure.
You should check with your physician immediately if symptoms of serious infection (such as continuing fever = 100.4 °F, severe stomach pain, pelvic tenderness, weakness, nausea, vomiting, diarrhea, non-productive cough shortness of breath, weight loss, or abnormally fast heartbeat) occur.
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.
This medicine can cause changes in heart rhythms, such as a condition called 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 any symptoms of heart rhythm problems, such as fast, pounding, or uneven heartbeats.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.
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.
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:
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:
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.