Taking Mifepristone
How Does Mifepristone Work?
Mifepristone is used to end early pregnancy. Early pregnancy means it is within 70 days (10 weeks) since the first day of your last menstrual period. Mifepristone works when taken in combination with another drug, misoprostol. Mifepristone blocks a hormone needed for a pregnancy to continue. Misoprostol causes contractions, which causes the uterus to expel the pregnancy.
How Is Mifepristone Taken?
Mifepristone is provided by a health care professional. Before your health care provider gives you mifepristone, you will be asked to review and sign an FDA-required Patient Agreement and Medication Guide. The Guide includes detailed instructions on how to take the pills, what to expect, potential risks of treatment, and contact information in case you experience any problems.
Key Steps in Your Medical Abortion
This information is intended as a supplement to the to information provided in the Medication Guide.
- Your health care provider will ask you to read and sign a Patient Agreement and give you a Medication Guide, instructions, and contact information.
- Your health care provider will instruct you on how to take the mifepristone tablet at their office and discuss an appropriate location for you to take the misoprostol tablets.
- You will be given four misoprostol tablets or a prescription for you to get them at a pharmacy.
- 24 – 48 hours after taking mifepristone, you will take the misoprostol by placing 2 tablets in each cheek pocket (4 tablets total). See the Medication Guide for detailed instructions.
- Within 2-24 hours you can expect cramping and heavy bleeding followed by spotting, which may last several days.
- See “What Symptoms Should You Be Concerned About?” below for symptoms that require immediate medical attention.
- It is very important that you follow up with your health care provider to make sure that your abortion was successful and that you are no longer pregnant.
- Although medical abortion is very effective at ending pregnancy, about 2 to 7 out of 100 will need a follow-up aspiration procedure to end their pregnancy or to stop too much bleeding.
When Could You Start Birth Control?
You can become pregnant again right after your pregnancy ends. If you do not want to get pregnant again, you can start using birth control pills, the patch, or the ring the day after you use misoprostol.
Your health care provider can help you explore options, choose the best contraceptive method for you, and tell you the best time to start using it.
What Symptoms Should You Be Concerned About?
Although cramping and bleeding are an expected part of ending a pregnancy, rarely, serious and potentially life-threatening bleeding, infections, or other problems can occur following a miscarriage, surgical abortion, medical abortion, or childbirth. Seeking medical attention as soon as possible is needed in these circumstances. Serious infection has resulted in death in a very small number of cases. There is no information that use of mifepristone and misoprostol caused these deaths. If you have any questions, concerns, or problems, or if you are worried about any side effects or symptoms, you should contact your health care provider.
Be sure to contact your provider promptly if you have any of the following:
- Heavy Bleeding. Contact your provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.
- Abdominal Pain or “Feeling Sick”. If you have abdominal pain or discomfort, or you are “feeling sick”, including weakness, nausea, vomiting, or diarrhea, with or without fever, more than 24 hours after taking misoprostol, you should contact your provider without delay. These symptoms may be a sign of a serious infection or another problem (including an ectopic pregnancy, a pregnancy outside the womb).
- Fever. In the days after treatment, if you have a fever of 100.4°F or higher that lasts for more than 4 hours, you should contact your provider right away. Fever may be a symptom of a serious infection or another problem.
If you cannot reach your health care provider, go to the nearest hospital emergency room.
Preparing for Your Medical Abortion
Before you move forward with your medical abortion, we recommend you prepare by taking the following steps:
- Make sure you have plenty of tampons or pads on hand for when you take the misoprostol (see “Day 3” above).
- Ask your health care provider about medicines to address symptoms like cramping and nausea.
- Talk with your health care provider about taking your misoprostol on a day off so you don’t have to deal with cramps and bleeding while at work or school (see “Day 3” above for further details on timing of cramping and bleeding).
- Talk to trusted friends or family so they’re aware of your upcoming medical abortion and can support you through the process.
- If you have children, consider setting up childcare coverage for the day you take the misoprostol. Friends and family can be great resources, even if they’re just spending the weekend with you to help with childcare and housework.
Who Should Not Take Mifepristone?
Some people should not take mifepristone. Do not take mifepristone if you:
- Have a pregnancy that is more than 70 days (10 weeks).
- Are using an IUD (intrauterine device or system). It must be taken out before you take mifepristone.
- Have been told by your healthcare provider you have a pregnancy outside the uterus (ectopic pregnancy).
- Have problems with your adrenal glands (chronic adrenal failure).
- Take medicine to thin your blood.
- Have a bleeding problem.
- Have porphyria.
- Take certain steroid medicines.
- Are allergic to mifepristone, misoprostol or medicines that contain misoprostol, such as Cytotec or Arthrotec.
Talk to your health care provider if you are not sure about all your medical conditions before taking this medicine.
Important Safety Information
Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.
IMPORTANT SAFETY INFORMATION
| WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristione tablets, 200 mg use. No causal relationship between the use of Mifepristone tablets, 200 mg and misoprostol and these events has been established.
Because of the risks of serious complications described above, Mifepristone tablets, 200 mg is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program. Before prescribing mifepristone, inform the patient about the risk of these serious events. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting, or diarrhea) for more than 24 hours after taking misoprostol. |
Contraindications
- Administration of Mifepristone tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions:
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
- Chronic adrenal failure (risk of acute adrenal insufficiency)
- Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency)
- History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
- Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
- Inherited porphyrias (risk of worsening or of precipitation of attacks)
- Use of Mifepristone tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, Mifepristone tablets, 200 mg may be used.
Warnings and Precautions
Infection and Sepsis
- As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifepristone tablets, 200 mg. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
- A high index of suspicion is needed to rule out sepsis (e.g., from Clostridium sordellii) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. No causal relationship between Mifepristone tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established. Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions.
Uterine Bleeding
- Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick, full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
- Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
- Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in patients who bleed heavily.
- Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfusions. Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to ≤ 0.1% of subjects. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.
Mifepristone REMS Program
Mifepristone tablets, 200 mg is available only through a restricted program under a REMS called the mifepristone REMS Program, because of the risks of serious complications.
Notable requirements of the mifepristone REMS Program include the following:
- Prescribers must be certified with the program by completing the Prescriber Agreement Form.
- Patients must sign a Patient Agreement Form.
- Mifepristone tablets, 200 mg must be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers.
Further information is available at 1-855-MIFEINFO (1-855-643-3463).
Ectopic Pregnancy
Mifepristone tablets, 200 mg is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifepristone tablets, 200 mg.
Patients who became pregnant with an IUD in place should be assessed for ectopic pregnancy.
Rhesus Immunization
The use of Mifepristone tablets, 200 mg is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.
Adverse Reactions
Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.
For additional information about mifepristone, see the Full Prescribing Information, including Boxed Warning.
Mifepristone tablets, 200 mg is indicated, in a regimen with misoprostol, for the medical termination of intrauterine pregnancy through 70 days gestation.
| WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING
Serious and sometimes fatal infections and bleeding occur very rarely following spontaneous, surgical, and medical abortions, including following Mifepristione tablets, 200 mg use. No causal relationship between the use of Mifepristone tablets, 200 mg and misoprostol and these events has been established.
Because of the risks of serious complications described above, Mifepristone tablets, 200 mg is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program. Before prescribing mifepristone, inform the patient about the risk of these serious events. Ensure that the patient knows whom to call and what to do, including going to an Emergency Room if none of the provided contacts are reachable, if they experience sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if they experience abdominal pain or discomfort, or general malaise (including weakness, nausea, vomiting, or diarrhea) for more than 24 hours after taking misoprostol. |
Contraindications
- Administration of Mifepristone tablets, 200 mg and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any of the following conditions:
- Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatment procedure will not be effective to terminate an ectopic pregnancy)
- Chronic adrenal failure (risk of acute adrenal insufficiency)
- Concurrent long-term corticosteroid therapy (risk of acute adrenal insufficiency)
- History of allergy to mifepristone, misoprostol, or other prostaglandins (allergic reactions including anaphylaxis, angioedema, rash, hives, and itching have been reported)
- Hemorrhagic disorders or concurrent anticoagulant therapy (risk of heavy bleeding)
- Inherited porphyrias (risk of worsening or of precipitation of attacks)
- Use of Mifepristone tablets, 200 mg and misoprostol for termination of intrauterine pregnancy is contraindicated in patients with an intrauterine device (“IUD”) in place (the IUD might interfere with pregnancy termination). If the IUD is removed, Mifepristone tablets, 200 mg may be used.
Warnings and Precautions
Infection and Sepsis
- As with other types of abortion, cases of serious bacterial infection, including very rare cases of fatal septic shock, have been reported following the use of Mifepristone tablets, 200 mg. Healthcare providers evaluating a patient who is undergoing a medical abortion should be alert to the possibility of this rare event. A sustained (> 4 hours) fever of 100.4°F or higher, severe abdominal pain, or pelvic tenderness in the days after a medical abortion may be an indication of infection.
- A high index of suspicion is needed to rule out sepsis (e.g., from Clostridium sordellii) if a patient reports abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting, or diarrhea) more than 24 hours after taking misoprostol. Very rarely, deaths have been reported in patients who presented without fever, with or without abdominal pain, but with leukocytosis with a marked left shift, tachycardia, hemoconcentration, and general malaise. No causal relationship between Mifepristone tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established. Clostridium sordellii infections have also been reported very rarely following childbirth (vaginal delivery and caesarian section), and in other gynecologic and non-gynecologic conditions.
Uterine Bleeding
- Uterine bleeding occurs in almost all patients during a medical abortion. Prolonged heavy bleeding (soaking through two thick, full-size sanitary pads per hour for two consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock. Counsel patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding following a medical abortion.
- Women should expect to experience vaginal bleeding or spotting for an average of 9 to 16 days. Women report experiencing heavy bleeding for a median direction of 2 days. Up to 8% of all subjects may experience some type of bleeding for 30 days or more. In general, the duration of bleeding and spotting increased as the duration of the pregnancy increased.
- Decreases in hemoglobin concentration, hematocrit, and red blood cell count may occur in patients who bleed heavily.
- Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfusions. Based on data from several large clinical trials, vasoconstrictor drugs were used in 4.3% of all subjects, there was a decrease in hemoglobin of more than 2 g/dL in 5.5% of subjects, and blood transfusions were administered to ≤ 0.1% of subjects. Because heavy bleeding requiring surgical uterine evacuation occurs in about 1% of patients, special care should be given to patients with hemostatic disorders, hypocoagulability, or severe anemia.
Mifepristone REMS Program
Mifepristone tablets, 200 mg is available only through a restricted program under a REMS called the mifepristone REMS Program, because of the risks of serious complications.
Notable requirements of the mifepristone REMS Program include the following:
- Prescribers must be certified with the program by completing the Prescriber Agreement Form.
- Patients must sign a Patient Agreement Form.
- Mifepristone tablets, 200 mg must be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers.
Further information is available at 1-855-MIFEINFO (1-855-643-3463).
Ectopic Pregnancy
Mifepristone tablets, 200 mg is contraindicated in patients with a confirmed or suspected ectopic pregnancy because mifepristone is not effective for terminating ectopic pregnancies. Healthcare providers should remain alert to the possibility that a patient who is undergoing a medical abortion could have an undiagnosed ectopic pregnancy because some of the expected symptoms experienced with a medical abortion (abdominal pain, uterine bleeding) may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may have been missed even if the patient underwent ultrasonography prior to being prescribed Mifepristone tablets, 200 mg.
Patients who became pregnant with an IUD in place should be assessed for ectopic pregnancy.
Rhesus Immunization
The use of Mifepristone tablets, 200 mg is assumed to require the same preventive measures as those taken prior to and during surgical abortion to prevent rhesus immunization.
Adverse Reactions
Most common adverse reactions (>15%) are nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness.
For additional information about mifepristone, see the Full Prescribing Information, including Boxed Warning.