Testosterone

Testosterone gel 1% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.

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. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum, the development of male hair distribution, such as facial, pubic, chest and axillary hair, laryngeal enlargement, vocal chord thickening, alterations in body musculature and fat distribution. Testosterone and DHT are necessary for the normal development of secondary sex characteristics. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies.

Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range. Starting dose of testosterone gel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet), applied once daily in the morning.

Testosterone gel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testosterone gel 1% is contraindicated in women who are pregnant. Testosterone gel 1% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1%. If a pregnant woman is exposed to testosterone gel 1%, she should be apprised of the potential hazard to the fetus. Men with carcinoma of the breast or known or suspected prostate cancer. Women who are pregnant. Testosterone may cause fetal harm.

Boxed warning (secondary exposure to testosterone): Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use. Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Avoid unintentional exposure of women or children to testosterone gel 1%. Secondary exposure to testosterone can produce signs of virilization. Testosterone gel 1% should be discontinued until the cause of virilization is identified. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products.

Most common adverse reactions (incidence ≥ 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders.

Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended. Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease.

Storage Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).