Provider Resources

Improve your Patients' Experience

Leverage our practice support materials to educate your patients about medical abortion and what to expect, to help improve adherence and success, and to offer comfort in what may be a stressful time. GenBioPro provides these easy-to-read, patient-friendly “before and after” instructions for your use:

Patient Agreement

Because mifepristone is available only under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS) program, a certified prescriber must dispense or supervise dispensing mifepristone. All patients receiving mifepristone for medical abortion must sign the Patient Agreement.

Download the Patient Agreement and the accompanying Medication Guide

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Medication Guide

Mifepristone is only available under an FDA-administered Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that before administering medical abortion, providers review the Patient Agreement and Medication Guide with the patient and secure the patient’s signature on the Agreement. This helps to ensure that patients understand the benefits and risks associated with medical abortion, and how to seek help if needed.

Download the Medication Guide

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Spanish
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Medical Abortion: Is It Right for You? 

This pamphlet answers the questions typically asked about medical abortion, addressing use, safety, efficacy, and risk. It is designed to help reduce concerns and anxiety in patients seeking a medical abortion. It also helps patients understand that they are not alone, and that medical abortion is widely practiced to help millions of patients end an early pregnancy in a safe and effective way.

Download Medical Abortion: Is It Right for You? and the accompanying Medication Guide

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Spanish
Chinese
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What to Expect Guide

This guide reviews how the two medical abortion drugs are administered, timing, possible side effects, and the follow-up clinic appointment. It also covers symptoms that require prompt attention, and what the patient should do in that event. This simple, graphic guide is a companion piece to the Patient Agreement and Medication Guide.

Download the What to Expect Guide and the accompanying Medication Guide

Need Translated Documents?

Spanish
Chinese
Vietnamese

Important Safety Information

Mifepristone tablets, 200mg 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 mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established.
    • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. 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. A high index of suspicion is needed 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. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
  • Because of the risks of serious complications described above, mifepristone is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.
  • Before prescribing mifepristone, inform the patient about these risks. Ensure 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 she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
  • Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe mifepristone, so that provider knows that she is undergoing a medical abortion.

 

Contraindications 

  • Administration of mifepristone and misoprostol for the termination of pregnancy 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 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 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. 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 if a patient reports abdominal pain, 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.

 

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 women who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. 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 is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (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 must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

 

Ectopic Pregnancy

Mifepristone 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.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

 

Rhesus Immunization

The use of mifepristone 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, click for the Full Prescribing Information, including Boxed Warning.

 

Important Safety Information
Show More

Mifepristone tablets, 200mg 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 mifepristone use. No causal relationship between the use of mifepristone and misoprostol and these events has been established.
    • Atypical Presentation of Infection. Patients with serious bacterial infections (e.g., Clostridium sordellii) and sepsis can present without fever, bacteremia or significant findings on pelvic examination. 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. A high index of suspicion is needed 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. Advise patients to seek immediate medical attention if they experience prolonged heavy vaginal bleeding.
  • Because of the risks of serious complications described above, mifepristone is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.
  • Before prescribing mifepristone, inform the patient about these risks. Ensure 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 she experiences sustained fever, severe abdominal pain, prolonged heavy bleeding, or syncope, or if she experiences abdominal pain or discomfort or general malaise (including weakness, nausea, vomiting or diarrhea) for more than 24 hours after taking misoprostol.
  • Advise the patient to take the Medication Guide with her if she visits an emergency room or another healthcare provider who did not prescribe mifepristone, so that provider knows that she is undergoing a medical abortion.

 

Contraindications 

  • Administration of mifepristone and misoprostol for the termination of pregnancy 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 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 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. 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 if a patient reports abdominal pain, 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.

 

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 women who bleed heavily.
  • Excessive uterine bleeding usually requires treatment by uterotonics, vasoconstrictor drugs, surgical uterine evacuation, administration of saline infusions, and/or blood transfu­sions. 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 is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (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 must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices and hospitals by or under the supervision of a certified prescriber

 

Ectopic Pregnancy

Mifepristone 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.

Women who became pregnant with an IUD in place should be assessed for ectopic pregnancy.

 

Rhesus Immunization

The use of mifepristone 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, click for the Full Prescribing Information, including Boxed Warning.