Seeking Abortion Care?
Talk to your health care provider to see if the abortion pill – mifepristone with misoprostol – may be right for you.
We Support Your Pregnancy Decision
At GenBioPro, we believe that you are the expert on your own life. You are the only one with enough information to determine your future and make personal health care decisions best for you and your family. If you choose to end your pregnancy, there may be several types of abortion care available to you. One of the most commonly used methods for ending a pregnancy within the first ten weeks is called “medical abortion.”
Medical Abortion and Mifepristone
Medical abortion involves taking two FDA-approved pills by mouth – mifepristone followed by misoprostol. Until recently, mifepristone had only been available in the US as a branded product. Now, an FDA-approved generic alternative from GenBioPro is available. The FDA carefully reviewed GenBioPro's mifepristone and found that it is equal to the branded product in quality and safety.
Medical abortion has been used safely and effectively by over a million people in the US since 2000. Mifepristone may be used up to 70 days from the first day of your last menstrual period. Medical abortion is becoming an increasingly common way to end an early pregnancy.
- Safe and Effective: 97% successful overall when used in combination with misoprostol.
- Non-Invasive: Abortion pill taken orally, instead of a procedure in a clinic or hospital.
How Do I Get Generic Mifepristone?
Generic mifepristone is not available in pharmacies or over the counter. It is available by prescription from health care providers who have enrolled in the GenBioPro Provider Program. Ask your trusted health care provider or find an abortion care service near you:
Planned Parenthood health centers
Call 1-800-230-PLAN
National Abortion Federation (NAF) member clinics
Call 1-800-772-9100
Abortion Care Network (ACN) member clinics
Call 1-202-419-1444
Abortion Clinics Online (ACOL) listings
Call 1-800-455-8130
Medical Abortion Has a Long History
Mifepristone, also known as the abortion pill or RU-486, was developed in 1980 and came into use in France in 1988. Since then, it has been used widely in Europe, and has been used safely and effectively in the US for more than 15 years as a brand-name medication. In 2019, GenBioPro introduced a generic version of mifepristone to the market. The FDA determined that it is a safe and effective generic equivalent to the branded pill.
Medical Abortion Is Common
Although many people do not talk about having an abortion, it is a very common procedure. By age 45, about half of US women will have an unintended pregnancy and one in four will have an abortion. Every year in the US, more than 300,000 people end a pregnancy through medical abortion. As of 2018, 3.7 million people in the US had used mifepristone for medical abortion.
Medical Abortion Safety
The FDA has thoroughly evaluated medical abortion and confirmed that it is reliable and effective. Serious complications of medical abortion are rare, happening for about 3 out of 1000 people. Unfortunately, misinformation about medical abortion has created some confusion and concern. However, it is important to remember serious risks do exist. See below for additional information about these risks, read the Medication Guide and discuss with your health care provider. In addition to providing a safe and affordable generic version of mifepristone, GenBioPro is committed to educating everyone about its safety and effectiveness in ending pregnancy.
Medical Abortion Is Effective
Mifepristone, when used in combination with misoprostol, is very effective in ending early pregnancy. It is successful in 97% of cases overall. That is the average of a 93-98% range in success rate, which depends on how far along the pregnancy is. Earlier termination, at under 49 days of pregnancy, has the highest rate of success: 98%. Later termination, near 70 days of pregnancy, has the lowest rate of success: 93%. A small percentage of people who take mifepristone – 2-7% – will need a follow-up aspiration procedure to end their pregnancy or to stop too much bleeding.
Your health care provider will check to make sure that your pregnancy has ended at 7 to 14 days after taking mifepristone and misoprostol. If you are still pregnant, or have a problem with bleeding, you will talk about next steps together.
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.