Estradiol Valerate injection (Delestrogen)

OFFICE ADMINISTRATION OR SELF ADMINISTRATION

Indications for Prior Authorization:

  • treatment of moderate to severe vasomotor symptoms associated with menopause
  • treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.  When prescrbing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
  • treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  • treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only)

Patients must meet the following criteria for the indications above:

  • Chart note documentation provided supports the use of estradiol injection is for an FDA approved or medically appropriate diagnosis, AND
  • Preferred oral or topcial therapies have been tried and failed OR injectable formulation is medically indicated

Dosing:

  • For vasomotor symtpoms, vulvar and vaginal atrophy associated with menopause: the usual dose is 10-20 mg every four weeks
    • The lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible
    • Attempts to discontinue or taper medication should be made at 3-month and 6-month intervals
  • For femal hypoestrogenism due to hypogonadism, castration, or primary ovarian failure: the usual dose is 10 to 20 mg every four weeks
  • For advanced androgen-dependent carcinoma of the prostate: the usual dosage is 30 mg or more administered every one or two weeks
    • for palliation only
  • The United States Pharmacopeia (USP) and Centers for Disease Control and Prevention (CDC) recommend if a multi-dose vial has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different date for that opened vial.  If not opened or accessed, it should be discarded according to the manufacturer's expiration date.

Approval:

  • limited to a 30-days supply per fill
  • first time approval: 6 months
  • Continuation: 1 year