Testosterone

DEA Class; Rx

Common Brand Names; Aveed, Depo-Testosterone, Testopel, Xyosted, Jatenzo, Tlando, Kyzatrex

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

Hypersensitivity to product or formulation components

Men with carcinoma of the breast or known or suspected carcinoma of the prostate

Men with hypogonadal conditions (eg, “age-related hypogonadism”) that are not associated with structural or genetic etiologies; efficacy has not been established for these conditions, and testosterone can increase BP which can increase the risk of MACE

Women: Pregnancy or prospect of pregnancy

Kyzatrex

• Increased hemoglobin (4.5%)

• Hypertension (2.6%)

• Increased PSA (2.6%)

• Headache (1.9%)

Tlando

• Blood prolactin increased (6.3%)

• Hypertension (5.1%)

• Hematocrit increased (4.3%)
• Upper respiratory tract infection (3.6%)
• Weight increased (2.1%)
• Headache (2.1%)
• Musculoskeletal pain (2.1%)

Acne

Abnormal dreams

Aggressive behavior

Alopecia

Anaphylaxis

Anger

Amnesia

Anxiety

Bladder irritability

Breast soreness

Deep venous thrombosis

Excessive frequency and duration of erection

Fatigue

Growth acceleration

Gynecomastia

Headache

Hirsutism

Hot flashes

Hypersensitivity

Hypercholesterolemia

Hypertension

Insomnia

Liver function alterations

Male pattern baldness

Menstrual irregularities

Priapism

Pruritus

Rash

Seborrhea

Suppression of factors II, V, VII, X

Vasodilation

Virilization

Water retention

May increase blood pressure (BP); before initiating, consider baseline cardiovascular (CV) risk and ensure BP is adequately controlled; check BP ~3 weeks after initiating or increasing dose and periodically thereafter; treat new-onset hypertension or exacerbations; reassess whether the benefits of continued treatment outweigh risks

Increased hematocrit (polycythemia) reflective of increases in RBC mass may require lower dose or discontinuation; evaluate hematocrit ~q3Months, and if elevated hold testosterone until hematocrit returns to normal; if testosterone restarted and again hematocrit increase, permanently discontinue testosterone; increased RBC mass may increase thromboembolic risk

Patients with BPH treated with androgens are at an increased risk for worsening of BPH signs and symptoms

Androgens may increase risk for prostate cancer; evaluate patients for prostate cancer before initiating and during treatment with testosterone

Venous thromboembolic events (VTE) reported, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement; evaluate patients who report symptoms of pain, edema, warmth, and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE; if VTE suspected, discontinue testosterone and initiate appropriate workup and management

Testosterone has been subject to abuse, typically at doses higher than recommended for approved indication and in combination with other anabolic androgenic steroids; anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions; if testosterone abuse suspected, check serum testosterone concentrations to ensure they are within therapeutic range; consider possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events

Prolonged use of high dose testosterone associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice); peliosis hepatis can be life-threatening or fatal; long-term therapy with IM testosterone enanthate has produced multiple hepatic adenomas; although not reported with other administration routes, monitor for signs or symptoms of hepatic dysfunction; promptly discontinue testosterone if jaundice occurs while evaluating cause

Gynecomastia may develop and persist in patients treated for hypogonadism

Contraindicated in pregnant women

Teratogenic; may cause fetal harm when administered to a pregnant woman based on data from animal studies and its mechanism of action

Not indicated for women