| Drug Name |
Testosterone enanthate |
| Drug ID |
BADD_D02172 |
| Description |
Testosterone enanthate is an esterified variant of testosterone that comes as an injectable compound with a slow-release rate. This slow release is achieved by the presence of the enanthate ester functional group attached to the testosterone molecule.[A31615] This testosterone derivative was first approved on December 24, 1953.[L8941]
In 2017, about 6.5 million retail prescriptions for testosterone therapy were filled [L4659]. The majority of the prescriptions written were for injectable (66%) and topical (32%) testosterone products. As recent as 1 October 2018, the US FDA approved Antares Pharma Inc.'s Xyosted - a subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable autoinjector [L4659]. As the first subcutaneous autoinjector product designed for testosterone replacement therapy, this innovative formulation removes transfer concerns commonly associated with testosterone gels and potentially reduces the need for in-office/in-clinic injection procedures that may inconvenience patients with frequent visits to the clinic [L4659]. |
| Indications and Usage |
Testosterone enanthate in males is indicated as a replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Some of the treated conditions are 1) primary hypogonadism, defined as testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome or orchidectomy; 2) hypogonadotropic hypogonadism due to an idiopathic gonadotropin or luteinizing hormone-releasing hormone deficiency or due to a pituitary-hypothalamic injury from tumors, trauma or radiation, in this case it is important to accompany the treatment with adrenal cortical and thyroid hormone replacement therapy; 3) to stimulate puberty in patients with delayed puberty not secondary to a pathological disorder. If the conditions 1 and 2 occur prior to puberty, the androgen replacement therapy will be needed during adolescent years for the development of secondary sexual characteristics and prolonged androgen treatment might be needed it to maintain sexual characteristics after puberty.[FDA label]
In females, testosterone enanthate is indicated to be used secondarily in presence of advanced inoperable metastatic mammary cancer in women who are from one to five years postmenopausal. It has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.[FDA label]
Testosterone enanthate injections that are currently formulated for subcutaneous use are specifically indicated only for primary hypogonadism and hypogonadotropic hypogonadism [F1941]. The use of such formulations is limited because the safety and efficacy of these subcutaneous products in adult males with late-onset hypogonadism and males less than 18 years old have not yet been established [F1941]. Moreover, subcutaneously administered testosterone enanthate is indicated only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies, considering the medication could cause blood pressure increases that can raise the risk of major adverse cardiovascular events like non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death [F1941]. |
| Marketing Status |
approved |
| ATC Code |
Not Available |
| DrugBank ID |
DB13944
|
| KEGG ID |
D00958
|
| MeSH ID |
C004648
|
| PubChem ID |
9416
|
| TTD Drug ID |
Not Available
|
| NDC Product Code |
22552-0014; 43647-567; 49803-005; 73774-015; 54436-200; 64025-0020; 48087-0137; 62991-2700; 0143-9750; 60870-0266; 63275-9938; 54436-275; 54436-250; 12875-9951; 51552-1336 |
| UNII |
7Z6522T8N9
|
| Synonyms |
testosterone enanthate | testosterone heptanoate | testosterone heptylate | Primoteston Depot | Testosteron Depot-Rotexmedica | Testosteron-Depot Eifelfango | Delatestryl | Testrin P.A. | Theramex | Andropository | Durathate | Testosteron-Depot Jenapharm |
