Ordering Mifeprex for Providers | Mifeprex (mifepristone)

We are pleased that you wish to become a provider of Mifeprex*(mifepristone).

Because of the risks of serious complications, Mifeprex is available only through a restricted program called the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program.

Notable Requirements of the Mifeprex REMS Program include the following:

Prescribers must be certified with the program by completing the Prescriber Agreement Form (PDF).
Patients must sign a Patient Agreement Form(PDF).
Mifeprex must only be dispensed to patients by or under the supervision of a certified prescriber, or by certified pharmacies on prescriptions issued by certified prescribers.

For complete information on the Mifeprex REMS Program, please go to Mifepristone REMS Program at FDA.

Become a Certified Mifeprex Provider

Healthcare providers who wish to prescribe Mifeprex must be specially certified. To become specially certified to prescribe Mifeprex, healthcare providers must:

Review the Prescribing Information for Mifeprex.
Complete and sign the Prescriber Agreement Form (PDF)
Fax or email the signed Prescriber Agreement Form to the distributor using the contact information listed on the form.

Your account information will be kept strictly confidential. If you oversee more than one office facility, you will need to list each facility on your order form prior to shipping the first order. If you have any questions regarding account setup or ordering Mifeprex, please email info@earlyoptionpill.com.

The distributor will call to finalize your account setup and take your first order. This is a one-time only process; subsequent orders may be phoned in. Once your account has been established, you will usually receive your order within 24 hours. You may request to return product you purchased from the distributor if at least 180 days of expiry remain on the product when the request is made to the distributor, and; the distributor confirms that the serial numbers on the returned product align with the serial numbers of product sold to that customer; and the product is in the original pristine carton(s) or intermediate packer(s) or the blistered tablet is found to be chipped, broken or missing.

Patient information materials, including Medication Guides and Patient Agreement Forms, will be provided together with your order of Mifeprex. View our patient support materials for additional patient information resources.

Qualifications and Guidelines for Mifeprex Providers

Mifeprex must be provided by or under the supervision of a certified prescriber who meets the following qualifications:

Ability to assess the duration of pregnancy accurately.

Ability to diagnose ectopic pregnancies.

Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made plans to provide such care through others, and ability to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Has read and understood the MIFEPREX Prescribing Information.

In addition to meeting these qualifications, you also agree to follow these guidelines for use:

Ensure that the Patient Agreement Form is reviewed with the patient and the risks of the mifepristone treatment regimen are fully explained. Ensure any questions the patient may have prior to receiving mifepristone are answered.

Ensure the healthcare provider and patient sign the Patient Agreement Form(PDF).
Ensure the patient is provided with a copy of the Patient Agreement Form (PDF) and the Medication Guide(PDF).

Ensure the signed Patient Agreement Form is placed in the patient’s medical record.

Ensure that any deaths of patients who received Mifeprex are reported to Danco Laboratories, LLC, identifying the patient by a non-identifiable reference and including the NDC and lot number from the package of Mifeprex that was dispensed to the patient.

Ensure that healthcare providers under your supervision follow the guidelines listed above.

If Mifeprex will be dispensed through a certified pharmacy:
- Assess appropriateness of dispensing Mifeprex when contacted by a certified pharmacy about patients who will receive Mifeprex more than 4 calendar days after the prescription was received by the certified pharmacy.
- Obtain the NDC and lot number of the package of Mifeprex the patient received in the event the prescriber becomes aware of the death of a patient.
If Mifeprex will be dispensed by you or by healthcare providers under your supervision:
- Ensure the NDC and lot number from each package of Mifeprex are recorded in the patient’s record.

A certified pharmacy may dispense mifepristone made by a different manufacturer than that stated on this Prescriber Agreement Form.

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 MIFEPREX use. No causal relationship between the use of MIFEPREX 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.

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, MIFEPREX is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the mifepristone REMS Program.

Before prescribing MIFEPREX, 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 MIFEPREX, so that provider knows that she is undergoing a medical abortion.

Important Safety Information

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING