Risk of serious bacterial (e.g., Clostridium sordellii) infection and sepsis, which can present without fever, bacteremia, or significant findings on pelvic examination. Deaths reported very rarely in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. (See Infection and Sepsis under Cautions and see Advice to Patients.)
Prolonged heavy vaginal bleeding may be a sign of incomplete abortion or other complications; may require prompt medical or surgical intervention. (See Hemorrhage under Cautions and see Advice to Patients.)
Discuss medication guide and patient agreement with patients. Ensure that patients know whom to call and what to do in an emergency. If patients visit an emergency room or clinician other than the original prescriber, advise patients to present medication guide to alert clinician of recent medical abortion.
REMS:
FDA approved a REMS for mifepristone to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of mifepristone and consists of the following: medication guide, elements to assure safe use, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
MIFEPRISTONE (mi FE pri stone) is a hormone-like drug. It is used in combination with other medicines to end an early pregnancy (usually during the first 7 weeks). This medicine is only available in a doctor's office, health clinic, or hospital.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
adrenal gland problems
bleeding problems
cannot easily get emergency medical help in the 2 weeks after you take this medicine
cannot return for follow up appointments after you take this medicine
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Before you take this medicine, read the information your doctor or health care provider gives you. Talk to your doctor about any questions you have. Take your medicine exactly as directed. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.
Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
This does not apply.
What may interact with this medicine?
Do not take this medicine with any of the following medications:
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
For your safety, you must visit your doctor as directed after taking this medicine. Report any unusual effects to your doctor. This medicine can cause birth defects. You will need surgery if this medicine fails to cause a full abortion.
After you take this medicine, some vaginal bleeding is normal. Heavy bleeding may be a sign that something is wrong. If you soak through 2 thick full-size sanitary pads each hour for 2 hours, get medical help right away. Tell the health care provider that you have taken this medicine.
Call your doctor if you have a fever, stomach pain or tenderness, nausea, vomiting, diarrhea, or feel weak. This may be a sign that something is wrong. You may have a serious infection or complication and need medical help.
Keep the MedGuide for this medicine. If you need emergency medical care, show your healthcare provider the MedGuide.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This drug is given in a hospital or clinic and will not be stored at home.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
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.
