Testosterone Topical

DEA Class; Rx

Common Brand Names; Androderm, AndroGel, Testim, Axiron, Fortesta, Vogelxo

Primary androgen in humans synthesized by testes, ovaries, and adrenal cortex; available in a variety of dosage forms
Primarily used in males with primary hypogonadism or with hypogonadism due to medical conditions; may be used for a limited duration for constitutional delay of puberty; used off-label in men with sexual dysfunction due to low testosterone associated with aging
Not recommended for low testosterone status alone due to aging due to potential risk for cardiovascular events and stroke

Males with breast or prostate cancer

Hypersensitivity

Breast feeding women

Pregnancy

• Pruritus at application site (37%)
• Skin reactions at application site (16.1%)
• Blisters under skin (12%)
• Erythema at application site (7%)
• Vesicles at application site (6%)
• Allergic contact dermatitis (4%)
• Burning at application site (3%)
• Induration at application site (3%)
• Abnormal dreams
• Acne
• Anaphylaxis
• Bladder irritability
• Breast soreness
• Cholestatic jaundice
• Deep vein thrombosis
• Dry skin
• Fatigue
• Gynecomastia
• Headache
• Insomnia
• Menstrual irregularities
• Priapism
• Suppression of factors II, V, VII
• Virilization

Use with caution in patients with chronic lung disease, obesity, advanced age, or preexisting cardiac, renal, or hepatic disease

Employ caution with prolonged use of high doses, which may be associated with hepatic effects

May increase risk of prostate cancer

Risk of gynecomastia when used for male hypogonadism

May change serum lipid profile; use with caution in patients who have history of mycoardial infarction (MI) or coronary artery disease (CAD)

Large doses may suppress spermatogenesis

May increase hematocrit, which requires dose adjustment or discontinuation; monitor serum testosterone, prostate specific antigen (PSA), liver function, lipid concentrations, hematocrit and hemoglobin periodically

May cause hypercalcemia in patients with prolonged immolibization or cancer

Anabolic activity of androgens may enhance hypoglycemia

Children: Risks of inappropriate genital enlargement, premature pubic hair, advanced bone age, increased libido, and aggressive behavior

Fortesta: Exogenous administration of androgens may lead to azoospermia; sleep apnea may occur in those with risk factors; preparation is flammable until dry

Discontinue if urethral obstruction develops in patients with benign prostatic hyperplasia (BPH); monitor patients with BPH for worsening of signs and symptoms of BPH

Edema with or without congestive heart failure, may be a complication in patients with pre-existing cardiac, renal, or hepatic disease; use with caution

May worsen sleep apnea in some male patients

Evaluate patients for cardiovascular risk factors prior to initiating therapy and monitor closely during therapy

Use caution in patients with diseases that may be exacerbated by fluid retention, including cardiac, hepatic, or renal dysfunction; not recommended for men with poorly controlled heart failure

Monitor women for virilization when treating for metastatic breast cancer

Geriatric patients may be at greater risk for prostatic hyperplasia, prostate cancer, fluid retention, and increase in transaminase levels

Increased hematocrit (polycythemia), reflective of increased red blood cell mass, may require discontinuation; increases risk for thromboemolism

Venous thromboembolism, including DVT and PE reported in patients using testosterone products; these observations have included patients with and without polycythemia; evaluate signs or symptoms consistent with DVT or PE; if venous thromboembolic event suspected, discontinue treatment with testosterone and initiate appropriate workup and management

Contraindicated in pregnant women; drug 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 female fetus to androgens may result in varying degrees of virilization

Drug is not indicated for use in women