Testosterone undecanoate injection (Aveed®) 

OFFICE ADMINISTRATION  [MEDICAL BENEFIT]

Indications for Prior Authorization: 
  • Indicated for testosterone replacement in adult males for conditions associated with a deficiency or absence of endogenous testosterone (primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism (congenital or acquired).
The following criteria must be met for coverage:
  • Patient is 18 years of age or older, AND
  • Diagnosis of hypogonadism confirmed by medical record documentation including lab documentation of morning serum testosterone concentrations below normal range, AND
  • Patient has persistent signs and symptoms (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido) of androgen deficiency (pre-treatment), AND
  • Other reasons for androgen deficiency have been ruled out (e.g. adrenal insufficiency, hypopituitarism), AND
  • Medical justification is provided why patient cannot use both topical testosterone (gel and patch), and testosterone for IM injection, AND
  • Limited to a 30 day supply per fill
  • Contraindicated in men with carcinomas of the breast or prostate
  • Warnings include serious pulmonary oil microembolism (POME) reactions and anaphylaxis
Dosing:
  • The recommended dose of Aveed is 3 mL (750 mg) injected intramuscularly, followed by 3 mL (750 mg) injected after 4 weeks, then 3 mL (750 mg) injected every 10 weeks thereafter.
Approval: 
  • 1 year

Last review date: May 19, 2020

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