Mifepristone

Mifepristone Brand Names- Korlym | Mifeprex

What is Mifepristone

Mifepristone is a synthetic steroid with potent antiprogesterone and antiglucocorticoid activity.

It has no estrogenic, antiestrogenic, mineralocorticoid, or antimineralocorticoid activity. It is a derivative of the synthetic progestin norethindrone.

Globally, mifepristone is most widely known as a postcoital contraceptive agent and, when used in combination with a prostaglandin, as an abortifacient in early pregnancy. Off-label investigational uses for mifepristone include the treatment of leiomyomata (uterine fibroids), endometriosis, and meningiomas refractory to other therapies.

While mifepristone has also been used for cervical priming and for induction of labor at term or in the case of intrauterine fetal death, the data are insufficient to recommend its use over other available drugs.

Mifepristone has been studied for the treatment of progesterone receptor positive breast cancer but demonstrated only minimal activity as a single agent.

The initial FDA approval for mifepristone (Mifeprex) for the termination of pregnancy (in combination with misoprostol) was granted in 2000; the product is available via restricted access directly to registered prescribers in the United States, and is not available in pharmacies.

The FDA also approved mifepristone (e.g., Korlym) for chronic use in patients with endogenous Cushing’s syndrome in 2012 and the product has a limited distribution program to ensure availability to Cushing’s patients and their healthcare professionals.

Indications

  1. Cushing’s syndrome
  2. endometriosis
  3. meningioma
  4. postcoital contraception
  5. pregnancy termination
  6. uterine leiomyomata

For pregnancy termination in combination with misoprostol, through 70 days (10 weeks) gestation dated from the first day of the last menstrual period

Side Effects

  1. abdominal pain
  2. adrenocortical insufficiency
  3. anaphylactoid reactions
  4. anemia
  5. angioedema
  6. anorexia
  7. anxiety
  8. arthralgia
  9. asthenia
  10. back pain
  11. bleeding
  12. chills
  13. constipation
  14. diarrhea
  15. dizziness
  16. dyspepsia
  17. dyspnea
  18. edema
  19. emotional lability
  20. endometrial hyperplasia
  21. fatigue
  22. fetal death
  23. fever
  24. flank pain
  25. gastroesophageal reflux
  26. headache
  27. hot flashes
  28. hypertension
  29. hypoglycemia
  30. hypokalemia
  31. hypotension
  32. infection
  33. insomnia
  34. leukocytosis
  35. maculopapular rash
  36. malaise
  37. menstrual irregularity
  38. musculoskeletal pain
  39. myalgia
  40. myasthenia
  41. nausea
  42. orthostatic hypotension
  43. palpitations
  44. pelvic pain
  45. peripheral edema
  46. pharyngitis
  47. polydipsia
  48. pruritus
  49. rash
  50. sinusitis
  51. stomatitis
  52. syncope
  53. teratogenesis
  54. toxic epidermal necrolysis
  55. urticaria
  56. uterine contractions
  57. vaginal bleeding
  58. vomiting
  59. weakness
  60. xerostomia

Monitoring Parameters

  • blood glucose
  • blood pressure
  • pelvic exam
  • pelvic ultrasound
  • pregnancy testing
  • urinary free cortisol

Contraindications

  • abdominal pain
  • adrenal insufficiency
  • anticoagulant therapy
  • apheresis
  • AV block
  • bleeding
  • bradycardia
  • breast-feeding
  • cardiomyopathy
  • celiac disease
  • coagulopathy
  • contraception requirements
  • contraceptive devices
  • corticosteroid therapy
  • diabetes mellitus
  • ectopic pregnancy
  • endometrial cancer
  • endometrial hyperplasia
  • females
  • fever
  • geriatric
  • heart failure
  • hemophilia
  • hepatic disease
  • human immunodeficiency virus (HIV) infection
  • hypercortisolism
  • hyperparathyroidism
  • hypocalcemia
  • hypokalemia
  • hypomagnesemia
  • hypothermia
  • hypothyroidism
  • immune thrombocytopenic purpura (ITP)
  • incomplete abortion
  • infection
  • long QT syndrome
  • myocardial infarction
  • pheochromocytoma
  • porphyria
  • pregnancy
  • pregnancy testing
  • QT prolongation
  • renal failure
  • renal impairment
  • reproductive risk
  • rheumatoid arthritis
  • sepsis
  • sickle cell disease
  • sleep deprivation
  • stroke
  • systemic lupus erythematosus (SLE)
  • vaginal bleeding

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