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Mifeprex Generic Name & Formulations
Legal Class
PP
General Description
Mifepristone 200mg; tabs.
Pharmacological Class
Abortifacient.
How Supplied
Single-dose pack—1
Manufacturer
Mifeprex Indications
Indications
Termination of intrauterine pregnancy through 70 days gestation, in a regimen with misoprostol.
Mifeprex Dosage and Administration
Adults and Children
Physician must sign and return Prescriber's Agreement; patient must read and sign Patient Agreement and read Medication Guide. Day 1: mifepristone 200mg as a single oral dose. Day 2 or 3: misoprostol 800mcg buccally within 24–48hrs after mifepristone dose. Day 7–14: confirm that complete termination of pregnancy has occurred by clinical exam or ultrasonographic scan.
Mifeprex Contraindications
Contraindications
Ectopic pregnancy or undiagnosed adnexal mass. IUD in place. Chronic adrenal failure. Prostaglandin allergy. Hemorrhagic disorders. Inherited porphyrias. Concurrent long-term corticosteroid or anticoagulant therapy.
Mifeprex Boxed Warnings
Boxed Warning
Serious and sometimes fatal infections or bleeding.
Mifeprex Warnings/Precautions
Warnings/Precautions
Risk of serious infections or bleeding. To be given only by or under the supervision of physicians who have signed and returned the Prescriber's Agreement; are able to assess gestational age of embryo and diagnose ectopic pregnancy; who have access to facilities for emergency treatment of incomplete abortion, severe bleeding, or resuscitation; and who meet requirements for storage, dose tracking, etc. Do surgical termination if mifepristone and misoprostol fail. Exclude ectopic pregnancy before treatment in patients with an IUD. Procedures to prevent rhesus immunization must be used. Hemostatic disorders. Hypocoagulability. Severe anemia. Pregnancy: treatment failure may result in fetal malformation. Nursing mothers: see full labeling.
REMS
Mifeprex Pharmacokinetics
Distribution
98% plasma protein bound.
Elimination
Fecal (83%), renal (9%). Half-life: 12–72 hours (initial); 18 hours (terminal).
Mifeprex Interactions
Interactions
See Contraindications. May potentiate CYP3A4 substrates. May be potentiated by ketoconazole, itraconazole, erythromycin, grapefruit juice. May be antagonized by rifampin, dexamethasone, St. John's wort, phenytoin, phenobarbital, carbamazepine.
Mifeprex Adverse Reactions
Adverse Reactions
Nausea, weakness, fever/chills, vomiting, headache, diarrhea, dizziness; uterine bleeding (may be prolonged or severe), cramping; rare: serious bacterial infections, sepsis (may be fatal).
Mifeprex Clinical Trials
See Literature
Mifeprex Note
Notes
Report serious adverse events by calling (877) 432-7596.
Mifeprex Patient Counseling
See Literature
