Testosterone gel

AndroGel

Approved uses

• 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...
• 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.

Forms and strengths

• Testosterone gel 1% for topical use is available as follows: A metered-dose pump.
• Each pump actuation delivers 12.5 mg of testosterone in 1.25g of gel.
• A unit dose packet containing 25 mg of testosterone provided in 2.5 g of gel.
• A unit dose packet containing 50 mg of testosterone provided in 5 g of gel.

How it is taken

• 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. Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%.
• Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply testosterone gel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back.
• Dose adjustment: testosterone gel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of total serum testosterone concentration. The dose should be titrated based on the serum testosterone concentration. Additionally, serum testosterone concentration should be assessed periodically.
• Patients should wash hands immediately with soap and water after applying testosterone gel 1% and cover the application site(s) with clothing after the gel has dried. Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.

Must not be used when

• 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%.

Interactions

• 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.

Warnings and precautions

• 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. Evaluate patients with signs or symptoms consistent with DVT or PE.
• Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy.
• Exogenous administration of androgens may lead to azoospermia.
• Edema, with or without congestive heart failure (CHF), may be a complication in patients with preexisting cardiac, renal, or hepatic disease.
• Sleep apnea may occur in those with risk factors.
• Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically.

Common side effects

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

Pregnancy

Testosterone gel 1% is contraindicated in pregnant women. Testosterone is teratogenic and may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action. Exposure of a female fetus to androgens may result in varying degrees of virilization.

How it acts

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.

Label holder:

Prasco Laboratories

Label version:

1 December 2024

This section reports the approved product information. The wording is condensed from the regulator's own summary, and the full document is linked under Sources.