Ordering

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Become a GenBioPro Provider

To begin prescribing generic mifepristone to your patients, you must first enroll in the GenBioPro Provider Program. It’s quick and easy.

  • Step 1: Download a Prescriber Agreement.
  • Step 2: The Medical Director must read and sign the form.
  • Step 3: Return the Agreement as instructed.

Generic mifepristone is available only under an FDA-administered Risk and Mitigation Strategy (REMS) program. The REMS program requires that, before ordering and receiving product, a signed Prescriber Agreement be on file with our authorized distributor.

Ordering Generic Mifepristone Is Simple, Fast, and Secure

Order Based on Your Practice 

We know that every practice is different, and our product packaging is specifically designed to meet provider needs. Select the packaging option and quantity that is best for your practice. 

Fulfillment Is Quick

Assuming your Prescriber Agreement has been established with our authorized distributor, most orders are shipped the same day.

Detailed Requirements for Mifepristone Providers

Mifepristone is available only under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that all GenBioPro providers complete and return our Prescriber Agreement, secure a signed Patient Agreement from each patient, and agree that a certified prescriber will dispense or supervise dispensing mifepristone.

All providers prescribing mifepristone must:

  • Review and understand the full prescribing information.
  • Be able to confirm that the pregnancy is within 70 days from the start of the patient’s last menstrual period and that it is uterine, rather than ectopic.
  • Walk the patient through the Patient Agreement and Medication Guide and fully explain the medical abortion process and its risks.
  • Sign and secure the patient’s signature on the Patient Agreement.
  • Provide the patient with a copy of the Patient Agreement and Medication Guide.
  • Retain the signed Patient Agreement and record of the serial number from the prescribed package of mifepristone in the patient’s medical record.
  • Provide, or direct patients to, facilities equipped for surgical intervention (including blood transfusion or resuscitation) in the event of an incomplete abortion or severe bleeding.
  • Contact GenBioPro immediately to report any adverse events, designating the patient by a non-identifiable reference and the recorded serial number from the package of mifepristone.

For more information, review the FDA-Approved Mifepristone REMS Program at

REMS@FDA
genbiopro-become-a-provider

Need More Information?

If you have questions about GenBioPro generic mifepristone, becoming a GenBioPro provider, or about ordering product, contact GenBioPro at:

Online | 1-855-MIFEINFO (1-855-643-3463) | info@genbiopro.com

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 renal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute renal 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 renal insufficiency)
    • Concurrent long-term corticosteroid therapy (risk of acute renal 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.