Mifepristone Tablets (Termination of Pregnancy)

What is this medication?

MIFEPRISTONE (mi FE pri stone) is used to end an early pregnancy. It works by decreasing levels of the hormone progesterone in the body, which stops the pregnancy from progressing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Mifeprex

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Bleeding disorder
• Cannot easily get emergency medical help in the 2 weeks after you take this medication
• Cannot return for follow-up appointments in 1 to 2 weeks after you take this medication
• Have an intrauterine device (IUD)
• Low adrenal gland function
• Porphyria
• Take medications that treat or prevent blood clots
• Taking steroids like dexamethasone or prednisone
• An unusual or allergic reaction to mifepristone, misoprostol, or other medications, foods, dyes, or preservatives
• Ectopic or tubal pregnancy
• It has been more than 70 days (10 weeks) since your last menstrual period began
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed. You will take this medication along with other medications. Talk to your care team about any questions you have.

A special MedGuide will be given to you. Be sure to read this information carefully.

Talk to your care team about the use of this medication in children. Special care may be needed.

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. This medication is not for regular use.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Regularly take steroid medications like budesonide, dexamethasone, methylprednisolone, prednisolone, prednisone, or cortisone

This medication may also interact with the following:

• Certain antibiotics like clarithromycin, erythromycin
• Certain medications for fungal infections like ketoconazole, itraconazole, or posaconazole
• Certain antivirals for HIV or hepatitis
• Certain medications for seizures like carbamazepine, phenytoin, phenobarbital
• Certain medications that treat or prevent blood clots like warfarin
• Grapefruit juice
• Rifampin
• St. John's Wort

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 medication?

For your safety, you must visit your care team as directed after taking this medication. Report any unusual effects to your care team. This medication can cause birth defects. You will need surgery if this medication fails to cause a full loss of pregnancy.

After you take this medication, 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.

Keep the MedGuide for this medication. If you need emergency medical care, show your care team the MedGuide. Tell the care team that you have taken this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heavy vaginal bleeding
• High fever
• Stomach pain, unusual weakness or fatigue, nausea, vomiting, diarrhea, or fever that lasts longer than expected

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Chills
• Dizziness
• Headache
• Stomach cramping

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 medication?

Keep out of reach of children and pets.

Store at 25 degrees C (77 degrees F). Get rid of any unused medication after the expiration date.

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.