Miscellaneous Ob/Gyn conditions:

Indications for: MIFEPREX

Termination of intrauterine pregnancy through 70 days gestation, in a regimen with misoprostol.

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:

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.

Boxed Warning:

Serious and sometimes fatal infections or bleeding.

MIFEPREX 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.

MIFEPREX Classification:

Abortifacient.

MIFEPREX 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.

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).

Note:

Report serious adverse events by calling (877) 432-7596.

Metabolism:

Primarily hepatic (CYP3A4). 

Drug Elimination:

Fecal (83%), renal (9%). Half-life: 12–72 hours (initial); 18 hours (terminal).

REMS:

YES

How Supplied:

Single-dose pack—1