Mifeprex

Appropriate Use

restricted distribution program (mifepristone REMS) due to serious infection and bleeding risk; prescribers, pharmacies must be certified and meet all requirements

Serious Infection Risk

serious and sometimes fatal infections occur very rarely after spontaneous, surgical, and medical abortions incl. mifepristone use; no causal relationship established b/w mifepristone and misoprostol and these events; atypical presentation of serious bacterial infections and sepsis incl. w/o fever, bacteremia, or significant findings on pelvic exam post-abortion; very rarely deaths reported in pts who presented w/o fever, w/ or w/o abdominal pain, but w/ leukocytosis w/ marked left shift, tachycardia, hemoconcentration, and general malaise; high index of suspicion needed to rule out serious infection and sepsis

Bleeding Risk

serious and sometimes fatal bleeding occurs very rarely after spontaneous, surgical, and medical abortions incl. mifepristone use; no causal relationship established b/w mifepristone and misoprostol and these events; prolonged heavy bleeding may be sign of incomplete abortion or other complications and prompt medical or surgical intervention may be needed; advise pts to seek immediate medical attention if prolonged heavy vaginal bleeding

Patient Information

inform pt of serious infection and bleeding risk and discuss medication guide and patient agreement before prescribing; ensure pt knows whom to call and what to do incl. go to ED if contacts not available if sx incl. sustained fever, severe abdominal pain, prolonged heavy bleeding, and syncope, or if abdominal discomfort/pain or general malaise incl. weakness, nausea, vomiting or diarrhea >24h after misoprostol dose