Tibolone

What is Tibolone

Tibolone is a synthetic steroid, structurally related to norethynodrel, that has weak estrogenic, progestogenic, and androgenic activity.

Tibolone is an oral medication that offers an alternative to conventional hormone replacement therapy for the treatment of menopausal symptoms and prevention of post-menopausal osteoporosis.

Tibolone use does not require the use of additional progestin to reduce risk for endometrial hyperplasia in women with an intact uterus.

Among older women with osteoporosis, tibolone decreased the risk of vertebral and non-vertebral fractures, particularly in patients who had already had a vertebral fracture.

Tibolone has been studied as an adjunct in women who require adjunctive treatment for hot flashes or bone loss prevention during GnRH agonist (e.g., leuprolide) treatment.

Use of tibolone was associated with an increased risk of stroke and therefore should not be used in women with risk factors for stroke.

In June 2006, the FDA did not approve tibolone for marketing in the U.S. for the treatment of symptoms related to menopause.

Tibolone is available in Europe and many other countries globally under the trade name Livial and is approved in European countries for relief of vasomotor symptoms related to menopause and for the prevention of osteoporosis in postmenopausal women.

Indications & Dosage

  • atrophic vaginitis
  • hot flashes
  • menopause
  • osteoporosis prophylaxis
  • uterine leiomyomata

For the treatment of vasomotor symptoms (e.g., hot flashes) or genitourinary symptoms (e.g., atrophic vaginitis) associated with menopause

Side Effects

  1. abdominal pain
  2. breakthrough bleeding
  3. depression
  4. dizziness
  5. dysmenorrhea
  6. edema
  7. headache
  8. mastalgia
  9. migraine
  10. nausea
  11. pruritus
  12. rash
  13. teratogenesis
  14. vaginal bleeding
  15. vaginal discharge
  16. vaginal irritation
  17. vomiting
  18. weight gain

Monitoring Parameters

  • LFTs
  • pap smear
  • pelvic exam
  • serum lipid profile

Contraindications

  • angina
  • asthma
  • atrial fibrillation
  • breast cancer
  • breast-feeding
  • cardiac disease
  • cerebrovascular disease
  • cervical cancer
  • children
  • cholelithiasis
  • coronary artery disease
  • diabetes mellitus
  • endometrial cancer
  • endometrial hyperplasia
  • endometriosis
  • gallbladder disease
  • geriatric
  • headache
  • hepatic disease
  • hepatocellular cancer
  • hypercholesterolemia
  • hyperlipidemia
  • hypertriglyceridemia
  • infants
  • jaundice
  • migraine
  • myocardial infarction
  • obesity
  • ovarian cancer
  • pregnancy
  • protein C deficiency
  • protein S deficiency
  • renal disease
  • reproductive risk
  • seizure disorder
  • stroke
  • surgery
  • systemic lupus erythematosus (SLE)
  • thromboembolic disease
  • thrombophlebitis
  • tobacco smoking
  • uterine cancer
  • uterine leiomyomata
  • vaginal bleeding
  • vaginal cancer
  • ventricular dysfunction

Interactions

No information is available regarding drug interactions associated with Tibolone

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