Prescribing

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Start Prescribing GenBioPro Generic Mifepristone Tablets, 200 mg

To begin prescribing mifepristone tablets, 200 mg, to your patients, you must first become a certified GenBioPro prescriber. It’s quick and easy.

  • Step 1: Download your Prescriber Agreement here.
  • Step 2: Fill out the form as instructed and sign where indicated.
  • Step 3: Submit the signed agreement to GenBioPro by faxing it to 1-877-239-8036 or by emailing it to RxAgreements@genbiopro.com.

If you will dispense directly to patients, our authorized distributor will contact you to establish an account and approve you to begin ordering.

If you will send orders to a pharmacy for dispensing, please also send your completed agreement to the certified pharmacy of your choice. Your Agreement must be on file before a certified pharmacy can fill your order. Click here to see a list of available certified pharmacies.

That’s it. You’re ready to start prescribing GenBioPro mifepristone tablets, 200 mg.

Fill out the prescriber agreement online

Restricted Prescribing Parameters

Mifepristone is available only under an FDA-approved Risk Evaluation and Mitigation Strategy (REMS) program. The REMS program requires that all certified GenBioPro prescribers complete and sign our Prescriber Agreement, returning a copy to our distributor for dispensing or to the certified pharmacy of choice for pharmacy dispensing. Additionally, it requires that prescribers secure a signed Patient Agreement from each patient.

Detailed Requirements for Certified GenBioPro Prescribers

All prescribers of generic mifepristone tablets, 200 mg, from GenBioPro 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.
  • Prescribers who dispense in person must record the NDC and lot numbers from the prescribed package of generic mifepristone tablets, 200 mg, 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 patient deaths that you become aware of, designating the patient by a non-identifiable reference. Prescribers dispensing must provide the NDC and lot numbers from the package of generic mifepristone tablets, 200 mg, or contact information for the certified pharmacy used to fill the prescription.

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

Use

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.

How to Prescribe and What to Expect

  • Prescribe a 200 mg generic mifepristone tablet to your patient, to be administered orally.
  • Prescribe 800 mcg misoprostol (four 200 mcg 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 generic mifepristone 200 mg tablet 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 the patient has questions.
  • 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.
  • Concurrent long-term corticosteriod therapy.
  • Allergy to mifepristone, misoprostol, other prostaglandins, 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.

 

Need More Information

Contact us if you have more questions about mifepristone, becoming a certified GenBioPro prescriber, ordering product, or to request additional copies of the full prescribing information or other resources:

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

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 Mifepristone tablets, 200 mg use. No causal relationship between the use of Mifepristone tablets, 200 mg 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 following an abortion. 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 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.

Important Safety Information
Show More

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 Mifepristone tablets, 200 mg use. No causal relationship between the use of Mifepristone tablets, 200 mg 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 following an abortion. 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 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.