Testosterone Enanthate (testosterone enanthate)

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Testosterone, the principal endogenous androgen, is a naturally occurring androgenic anabolic steroid hormone.

Testosterone is used for replacement or substitution of diminished or absent endogenous testicular hormone caused by certain medical conditions.

Generic name: testosterone enanthate
Pronunciation: (tess-TOSS-ter-own)

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Testosterone Enanthate:

  • Androgen Deficiency
  • Bilateral Anorchia
  • Bilateral Orchiectomy
  • Chemotherapy-Induced Hypogonadism
  • Cryptorchidism
  • Delayed Puberty
  • Gonadotropin Releasing Factor Deficiency
  • Hormone Receptor Positive Breast Cancer
  • Klinefelter's Syndrome
  • Male Hypogonadism
  • Primary Hypogonadism Due To Bilateral Torsion Of Testes
  • Primary Hypogonadism Due To Orchitis

Also known as: Absence Of Testes, Bilateral Orchectomy, Bilateral Orchidectomy, Bilateral Testectomy, Gnrh Deficiency, Gonadotropin Releasing Hormone Deficiency, Hormone Receptor Positive Malignant Neoplasm Of Breast, Lhrh Deficiency, Luliberin Deficiency, Luteinizing Hormone-Releasing Hormone Deficiency, Male Castration, Primary Failure Of Testis Due To Orchitis, Primary Gonadal Failure Due To Testitis, Primary Hypogonadism Due To Bilateral Testicular Torsion, Primary Male Hypogonadism Due To Orchiditis, Sexual Development Delayed, Sexual Development Retardation, Testoid Deficiency, Testosterone Deficiency, Undescended Testis.

Dosing

Dosage of testosterone is variable and should be individualized according to the condition being treated; the severity of symptoms; the patient's age, gender, and history of prior androgenic therapy; and the specific testosterone preparation being used.

Various dosage regimens have been used to induce pubertal changes in hypogonadal males. Some clinicians recommend that lower dosages be used initially, followed by gradual increases in dosage as puberty progresses; subsequently, the dosage may be decreased to maintenance levels. Other clinicians state that higher dosages are required initially to induce pubertal changes and lower dosages can then be used for maintenance therapy after puberty. The chronologic and skeletal ages of the patient must be considered when determining the initial dosage and subsequent dosage adjustment.

Diagnosis of hypogonadism must be confirmed by laboratory testing prior to initiation of testosterone therapy. To confirm this diagnosis, serum testosterone concentrations should be measured in the morning on at least 2 separate days and must be consistently below the normal range. Serum testosterone concentrations may be low later in the day in men with or without hypogonadism; therefore, measuring testosterone concentrations later in the day should be avoided.

The manufacturers of testosterone enanthate injection, testosterone undecanoate injection, and testosterone transdermal system, topical gel, topical solution, nasal gel, and buccal tablets state that clinical studies involving patients with renal or hepatic impairment have not been conducted. Therefore, there are no special population dosage recommendations at this time.

Drug interactions

Testosterone may potentiate the action of oral anticoagulants, causing bleeding in some patients. When testosterone therapy is initiated in patients receiving oral anticoagulants, dosage reduction of the anticoagulant may be required to prevent an excessive hypoprothrombinemic response. In patients receiving concomitant therapy with testosterone and anticoagulants, more frequent monitoring of INR and prothrombin time is recommended, especially during initiation or discontinuance of therapy.

Increased serum oxyphenbutazone concentrations have reportedly occurred in patients receiving androgens concurrently with oxyphenbutazone.

Changes in insulin sensitivity or glycemic control may occur in patients receiving androgen therapy. The metabolic effects of androgens may decrease blood glucose concentrations and insulin requirements in patients with diabetes.

Concomitant administration of testosterone with ACTH or corticosteroids may result in increased fluid retention and edema formation. Therefore, testosterone should be administered with caution in patients with cardiac, renal, and/or hepatic disease. Patients should be monitored for fluid retention and edema formation.

Administration of IM testosterone cypionate resulted in increased clearance of propranolol in one study. It is not known whether there is a potential for this interaction with topically administered testosterone gel.

Topical administration of 0.1% triamcinolone cream prior to application of a testosterone transdermal system did not alter absorption of testosterone; however, pretreatment with topical administration of triamcinolone ointment substantially reduced absorption of testosterone.

Administration of intranasal oxymetazoline, a sympathomimetic nasal decongestant, prior to administration of testosterone nasal gel (Natesto(R)) did not alter absorption of testosterone. Concomitant administration of testosterone nasal gel with other drugs administered intranasally has not been studied. The manufacturer does not recommend concomitant use with such drugs.

Contraindications

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Adverse reactions

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Precautions

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ICD codes

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Formulary status

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Last reviewed · Source: First Databank (FDB) drug data