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Basic Drug Info
Drug Name:Testosterone Enanthate
Manufacturer:Watson Laboratories, Inc.
Other Info:



Clinical Trials:


Indications and Usage

1.

Males: Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone:Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy.Hypogonadotropic hypogonadism (congenital or acquired) -idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.

(Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.)If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics.

Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty.

These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date.

Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support.

The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration.

An x-ray of the hand and wrist to determine bone age should be obtained every 6 months to assess the effect of treatment on the epiphyseal centers (See WARNINGS).2.

Females: Androgens may be used secondarily in women with advancing inoperable metastatic (skeletal) mammary cancer who are 1 to 5 years postmenopausal.

Primary goals of therapy in these women include ablation of the ovaries.

Other methods of counter-acting estrogen activity are adrenalectomy, hypophysectomy, and/or antiestrogen therapy.

This treatment has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.

Judgement concerning androgen therapy should be made by an oncologist with expertise in this field.
Malnutrition -- disorder of nutrition due to unbalanced or insufficient diet or to defective assimilation or utilization of nutrients.

Primary hypogonadism --

Primary testicular failure --

Torsion (malposition) --

Orchitis -- Inflammation of a TESTIS. It has many features of EPIDIDYMITIS, such as swollen SCROTUM; PAIN; PYURIA; and FEVER. It is usually related to infections in the URINARY TRACT, which likely spread to the EPIDIDYMIS and then the TESTIS through either the VAS DEFERENS or the lymphatics of the SPERMATIC CORD.

Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

Hypogonadotropic hypogonadism --

Neoplasms -- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.

Delayed Puberty -- The lack of development of SEXUAL MATURATION in boys and girls at a chronological age that is 2.5 standard deviations above the mean age at onset of PUBERTY in a population. Delayed puberty can be classified by defects in the hypothalamic LHRH pulse generator, the PITUITARY GLAND, or the GONADS. These patients will undergo spontaneous but delayed puberty whereas patients with SEXUAL INFANTILISM will not.

pathologic process -- The abnormal mechanisms and forms involved in the dysfunctions of tissues and organs.

Adverse effects -- Problems that occur when treatment affects tissues or organs other than the ones meant to be affected by the treatment. Common side effects of cancer treatment are fatigue, pain, nausea, vomiting, decreased blood cell counts, hair loss, and mouth sores.

Neoplasm Metastasis -- The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

Breast Carcinoma -- (brest KAN-ser) Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

Malignant neoplasm of breast -- A primary or metastatic malignant neoplasm involving the breast. The vast majority of cases are carcinomas arising from the breast parenchyma or the nipple. Malignant breast neoplasms occur more frequently in females than in males. -- 2003

Contraindications

Androgens are contraindicated in men with carcinomas of the breast or with known or suspected carcinomas of the prostate, and in women who are or may become pregnant.

When administered to pregnant women, androgens cause virilization of the external genitalia of the female fetus.

This virilization includes clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure.

The degree of masculinization is related to the amount of drug given and the age of the fetus, and is most likely to occur in the female fetus when the drugs are given in the first trimester.

If the patient becomes pregnant while taking these drugs, she should be apprised of the potential hazard to the fetus.
Carcinoma -- A malignant neoplasm made up of epithelial cells tending to infiltrate the surrounding tissues and give rise to metastases. It is a histological type of neoplasm but is often wrongly used as a synonym for "cancer." (From Dorland, 27th ed)

Virilism -- Development of male secondary SEX CHARACTERISTICS in the FEMALE. It is due to the effects of androgenic metabolites of precursors from endogenous or exogenous sources, such as ADRENAL GLANDS or therapeutic drugs.

ENLARGED CLITORIS --

Warnings

In patients with breast cancer, androgen therapy may cause hypercalcemia by stimulating osteolysis.

In patients with cancer, hypercalcemia may indicate progression of bony metastasis.

If hypercalcemia occurs, the drug should be discontinued and appropriate measures instituted.Prolonged use of high doses of androgens has been associated with the development of peliosis hepatis and hepatic neoplasms including hepatocellular carcinoma.

(See PRECAUTIONS–Carcinogenesis).

Peliosis hepatis can be a life-threatening or fatal complication.Cholestatic hepatitis and jaundice occur with 17-alpha-alkylandrogens at a relatively low dose.

If cholestatic hepatitis with jaundice appears or if liver function tests become abnormal, the androgen should be discontinued and the etiology should be determined.

Drug-induced jaundice is reversible when the medication is discontinued.Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hypertrophy and prostatic carcinoma.Edema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease.

In addition to discontinuation of the drug, diuretic therapy may be required.

If the administration of testosterone enanthate is restarted, a lower dose should be used.Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.Androgen therapy should be used cautiously in healthy males with delayed puberty.

The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every 6 months.

In children, androgen treatment may accelerate bone maturation without producing compensatory gain in linear growth.

This adverse effect may result in compromised adult stature.

The younger the child, the greater the risk of compromising final mature height.This drug has not been shown to be safe and effective for the enhancement of athletic performance.

Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.
Branded Drugs
The following US Branded drugs contain Testosterone Enanthate


DITATE-DS -- SAVAGE LABORATORIES INC DIV ALTANA INC

TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE -- WATSON LABORATORIES INC

DELATESTRYL -- ENDO PHARMACEUTICAL SOLUTIONS INC


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