Aveed (testosterone undecanoate) injection

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved March 2014

Specific Treatments:

hypogonadism

Therapeutic Areas

General Information

Aveed (testosterone undecanoate) injection is an ester of the androgen, testosterone. Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.

Aveed is specifically indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).

Aveed is supplied as a solution for intramuscular administration. 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. Aveed should be injected deeply into the gluteal muscle.

Clinical Results

FDA Approval
The FDA approval of Aveed was based on an 84-week, single-arm, open-label, multicenter study which enrolled 130 hypogonadal adult men with morning serum total testosterone concentrations <300 ng/dL (mean screening testosterone concentration 215 ng/dL). All subjects received injections of Aveed 750 mg at baseline, at 4 weeks, and then every 10 weeks thereafter. The primary endpoint was the percentage of subjects with average serum total testosterone concentration (Cavg) within the normal range (300-1000 ng/dL) after the third injection, at steady state. A total of 117 out of 130 subjects completed study procedures through Week 24 and were included in the evaluation of testosterone pharmacokinetics after the third Aveed injection. Ninety-four percent (94%) of subjects maintained a Cavg within the normal range (300 to 1000 ng/dL). The secondary endpoint was the percentage of subjects with maximum total testosterone concentration (Cmax) above three pre­determined limits: greater than 1500 ng/dL, between 1800 and 2499 ng/dL, and greater than 2500 ng/dL. The percentage of subjects with Cmax >1500 ng/dL was 7.7%; none of the subjects had a Cmax >1800 ng/dL.

Side Effects

Adverse events associated with the use of Aveed may include, but are not limited to, the following:

  • acne
  • injection site pain
  • prostatic specific antigen (PSA) increased
  • estradiol increased
  • hypogonadism
  • fatigue
  • irritability
  • hemoglobin increased
  • insomnia
  • mood swings

Mechanism of Action

Aveed (testosterone undecanoate) injection is an ester of the androgen, testosterone. Endogenous androgens, including testosterone and dihydrotestosterone (DHT) are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Male hypogonadism is a clinical syndrome resulting from insufficient secretion of testosterone. It has two main etiologies. Primary hypogonadism is caused by defects of the gonads, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Additional Information

For additional information regarding Aveed or hypogonadism, please visit the AVeedUSA web page.