No serious adverse reactions were reported in tolerance studies in healthy non-pregnant female and healthy male subjects where mifepristone was administered in single doses greater than threefold that recommended for termination of pregnancy. If a patient ingests a massive overdose, she should be observed closely for signs of adrenal failure.

The oral acute lethal dose of mifepristone in the mouse, rat and dog is greater than 1000 mg/kg (about 100 times the human dose recommended for termination of pregnancy).

Administration of Mifeprex and misoprostol for the termination of pregnancy (the “treatment procedure”) is contraindicated in patients with any one 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) (see WARNINGS);
• IUD in place (see INDICATION AND USAGE);
• Chronic adrenal failure;
• Concurrent long-term corticosteroid therapy;
• History of allergy to mifepristone, misoprostol or other prostaglandin;
• Hemorrhagic disorders or concurrent anticoagulant therapy;
• Inherited porphyrias.

Because it is important to have access to appropriate medical care if an emergency develops, the treatment procedure is contraindicated if a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation during the period from the first visit until discharged by the administering physician.

Mifeprex also should not be used by any patient who may be unable to understand the effects of the treatment procedure or to comply with its regimen. Patients should be instructed to review the MEDICATION GUIDE and the PATIENT AGREEMENT provided with Mifeprex carefully and should be given a copy of the product label for their review. Patients should discuss their understanding of these materials with their health care providers, and retain the MEDICATION GUIDE for later reference (see PRECAUTIONS).

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