Mifepristone (Mifeprex) for Early Abortion: Prescription Requirements, Regimen, and Safety

Mifepristone (RU-486) is a progesterone receptor antagonist used with misoprostol for medication abortion up to 70 days (10 weeks) gestation.

Regulatory Framework (US)

• REMS program: Certified prescribers only; dispensing in certified pharmacies/clinics; patient agreement form.
• Gestational limit: ≤70 days (10 weeks) LMP per FDA label; some states impose earlier bans.
• In-person vs. telehealth: FDA 2023 removed in-person dispensing requirement; mail-order from certified pharmacies permitted where state law allows.

Standard Regimen

1. Day 1: Mifepristone 200 mg orally.
2. 24–48 hours later: Misoprostol 800 mcg buccal (4 × 200 mcg tablets held in cheek pouches 30 min, then swallow) or vaginal.
3. Follow-up: 7–14 days (clinical assessment, hCG trend, or ultrasound) to confirm completion.

Efficacy & Outcomes

• Complete abortion: 95–98% (≤9 weeks); slightly lower at 9–10 weeks.
• Bleeding: heavier than period, 9–16 days average.
• Cramping: moderate-severe; NSAIDs + ondansetron as needed.

Contraindications & Precautions

• Ectopic pregnancy (must rule out with ultrasound).
• Chronic adrenal failure, long-term corticosteroid therapy.
• Bleeding disorders, anticoagulation.
• IUD in situ (remove first).
• Allergy to mifepristone/misoprostol.

Safety

Major complications (hemorrhage requiring transfusion, serious infection) <0.5%. Mortality ~0.0006% (lower than childbirth).

Access

Consult reproductive health provider (Planned Parenthood, abortion funds, telehealth platforms where legal).