Ordering | Mifeprex | Mifepristone | ru486

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 MIFEPREX 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 and Account Setup Form (PDF).
Patients must sign a Patient Agreement Form (PDF).
Mifeprex 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.

For complete information on the Mifeprex REMS Program, please go to MIFEPREX 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 (PDF) .
Complete and sign the Prescriber Agreement and Account Setup Form (PDF)
Fax the Account Setup Form to the Distributor (page 2 of the Prescriber Agreement 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 call 1-877-432-7596.

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. Unopened, unused product may be returned for a refund or exchange up to a year after the expiration date.

Patient information materials, including Medication Guides and chart-sized Patient Agreement Forms, will be provided together with your order of Mifeprex. If you would like additional patient information materials you may download them by clicking here . You can also order additional materials to be sent directly to your office by downloading the Reimbursement Information and Additional Materials Order Form (PDF) and faxing it to the distributor.

Qualifications and Guidelines for Mifeprex Providers

Mifeprex must be provided by or under the supervision of a healthcare provider who prescribes and 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 Prescribing Information for Mifeprex (PDF).

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

Review the Patient Agreement Form with the patient and fully explain the risks of the Mifeprex treatment regimen. Answer any questions the patient may have prior to receiving Mifeprex.

Sign and obtain the patient’s signature on the Patient Agreement(PDF).
Provide the patient with a copy of the Patient Agreement (PDF) and the Medication Guide(PDF).

Place the signed Patient Agreement Form in the patient’s medical record.

Record the serial number from each package of Mifeprex in each patient’s record.
Report any deaths to Danco Laboratories, identifying the patient by a non-identifiable reference and the serial number from each package of Mifeprex.

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 MIFEPREX 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.

Ordering Mifeprex

Important Safety Information

WARNING: SERIOUS AND SOMETIMES FATAL INFECTIONS OR BLEEDING