Prescribing

genbiopro-become-a-provider

Become a GenBioPro Provider to Start Prescribing

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: Fill out the form as instructed and sign where indicated.
  • Step 3: Return the Agreement to the fax number listed on the form.

Our authorized distributor will contact you directly once your account is established and you are ready to order. That’s all it takes to become a GenBioPro provider.

Restricted Prescribing Parameters

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.

Detailed Requirements for Mifepristone Providers

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

You are now leaving.

You are now leaving www.genbiopro.com. Links to all outside sites are independent sites not operated by GenBioPro, Inc. Any information on and the operations of the site you are going to are solely subject to the control of the organization operating the site.

Cancel
Continue
REMS@FDA

Indication

Mifepristone is used in combination with misoprostol to carry out an early abortion. “Early” is defined as up to 70 days from the first day of your patient’s last menstrual period.

Dosage and Administration

  • Provide a 200mg generic mifepristone pill to your patient, to be administered orally.
  • Dispense or prescribe 800mcg misoprostol (four 200mcg tablets) to be taken buccally 24-48 hours after ingestion of mifepristone. Tell the patient to place 2 tablets in each cheek pouch for 30 minutes and then swallow any remnants with liquid.
  • Provide additional medicine or prescriptions to help manage common cramps or gastrointestinal symptoms.
  • Most pregnancies will be expelled within 2-24 hours after the administration of the misoprostol.
  • Follow up with your patient 7 to 14 days following ingestion of the mifepristone to assess bleeding and confirm termination of pregnancy.
genbiopro-medication-guide-cover

Preparing Patients for Side Effects

Download the Medication Guide.

Provide your patient with:

  • Medicine or prescriptions for cramps, nausea, or diarrhea as desired.
  • Instructions on what to do in the event of significant discomfort, excessive vaginal bleeding, or other significant adverse reactions.
  • A phone number to call if she has questions after taking the misoprosotol.
  • The name and phone number of the health care provider who will handle emergencies.

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. Mifepristone is not effective for terminating ectopic pregnancies.
  • Chronic adrenal failure.
  • Presence of certain steroid medicines.
  • Allergy to mifepristone, misoprostol, other prostogladins, or medicines containing them, such as Cytotec or Arthrotec.
  • Hemorrhagic disorders or concurrent anticoagulant therapy, which may increase the risk of heavy bleeding.
  • Inherited prophyrias.
  • Presence of an IUD (intrauterine device or system). It must be removed before the administration of mifepristone.

Warnings and Precautions

Heavy bleeding, cramping, and nausea are common side effects of the mifepristone / misoprostol regimen. The following are serious and sometimes fatal complications, requiring immediate medical attention:

  • Infection and sepsis: a sustained fever of ≥100.4°F, severe abdominal pain, or pelvic tenderness may be indications of an infection.
  • Uterine bleeding: prolonged heavy bleeding (soaking through two thick sanitary pads per hour for 2 consecutive hours) may be a sign of incomplete abortion or other complications.

Drug Interactions

Some drugs may reduce or increase the exposure to mifepristone:

  • Presence of CYP 3A4 inducers, including rifampin, dexamethasone, St. John’s Wort, and certain anticonvulsants such as phenytoin, phenobarbital, and carbamazine. These may induce mifepristone metabolism and impact the efficacy of the dose.
  • Presence of CYP 3A4 inhibitors, including ketoconazole, itraconazole, erythromycin, and grapefruit juice, which may inhibit mifepristone metabolism.
  • Presence of CYP 3A4 substrates with narrow therapeutic range.

Refer to the Important Safety Information below for further information.


Contact us here or at 1-855-MIFEINFO (1-855-643-3463) or at info@genbiopro.com to learn more about the advantages of becoming a GenBioPro provider, or to request additional copies of the full prescribing information or other resources.

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.