Early Options: The Standard, FDA-Approved Regimen

Early Options - A Provider's Guide to Medical Abortion

After reading this page, you should be able to answer the following questions:
The FDA-approved labeling for mifepristone includes a "standard" protocol for medical abortion with mifepristone/misoprostol. What is NOT included in this protocol?
When is medical abortion with mifepristone/misoprostol contraindicated?

Medical abortion with mifepristone and misoprostol must be provided by or under the supervision of a physician able to assess gestational age accurately and diagnose ectopic pregnancy. The physician must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding or have plans in place to provide such care through others.⁶

As with surgical abortion methods, patients must have access to emergency medical facilities. These qualifications, along with several guidelines for use, are outlined in the Prescriber's Agreement that providers must sign off on to order mifepristone. Click here to view Figure 3.

Mifepristone is labeled for use in combination with orally administered misoprostol for medical abortion through 49 days' gestation. Thorough patient counseling and informed consent are essential components of the process. Each patient must receive the Medication Guide and sign the Patient Agreement supplied by Danco Laboratories, the U.S. licensee of mifepristone.

Providers should give patients clear instructions on whom to call and what to do in the event of an emergency. In addition, clinicians must apprise patients of the need to undergo a surgical abortion if the medical abortion is unsuccessful. Medical contraindications to abortion with mifepristone and misoprostol include:

Known allergy to mifepristone, misoprostol, or other prostaglandins
Concurrent long-term corticosteroid therapy
Chronic adrenal failure
Hemorrhagic disorders or concurrent anticoagulant therapy
Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
IUD in place (remove before administering mifepristone)
Inherited porphyrias

On day 1, mifepristone 600 mg is taken orally. Rh (D) immune globulin should be administered to Rh negative women any time before misoprostol administration. A small percentage (2% to 5%) of women may abort before taking misoprostol,^7-9 so it is reasonable to administer D immune globulin to appropriate patients at the time of the first visit. A dose of 50 µg usually provides adequate protection against isoimmunization through 12 weeks' gestation.

On day 3, the patient returns to the office for misoprostol. If the patient reports bleeding consistent with passage of the pregnancy, the clinician should perform either a clinical examination or an ultrasound assessment (or both) to determine if the pregnancy has already been expelled; this would obviate the need for additional medications.

If abortion has not occurred, 400 µg of misoprostol (two 200-µg tablets) is administered in a single oral dose. The patient returns for follow-up around day 14. If the abortion provider suspects an ongoing pregnancy, ultrasound is necessary to assess gestational cardiac activity. Prompt surgical abortion is recommended if cardiac activity is present. Click here to view Figure 4.

Click here to check your understanding.

Proceed to Clinical Trials Using the Standard Regimen.

References for this module