Testosterone - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH.

Potential for Secondary Exposure to Testosterone: Avoid unintentional exposure of women or children to testosterone gel, 1.62%.

Secondary exposure to testosterone can produce signs of virilization.

Testosterone gel, 1.62% should be discontinued until the cause of virilization is identified.

Venous Thromboembolism (VTE): 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.

Blood Pressure Increases: Testosterone gel, 1.62% can increase blood pressure, which can increase cardiovascular risk over time.

Measure blood pressure periodically.

Not recommended for use in men with uncontrolled hypertension Potential for Adverse Effects on Spermatogenesis: Exogenous administration of androgens may lead to azoospermia.

Edema: Edema, with or without congestive heart failure (CHF), may be a complication in patients with preexisting cardiac, renal, or hepatic disease. ( 5.10 , 6.2 ) Sleep apnea: 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. ( 5.1 , 5.3 , 5.9 , 5.13 ) Flammability: Testosterone gel, 1.62% is flammable until dry.

5.1 Potential for Secondary Exposure to Testosterone Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance.

Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age.

In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel.

In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age.

The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product.

Children and women should avoid contact with unwashed or unclothed application sites in men using testosterone gel, 1.62% [see Dosage and Administration , Use in Specific Populations and Clinical Pharmacology ].

Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician.

Testosterone gel should be promptly discontinued until the cause of virilization has been identified.

5.2 Polycythemia Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone.

Check hematocrit prior to initiating treatment.

It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually.

If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration.

An increase in red blood cell mass may increase the risk of thromboembolic events.

5.3 Venous Thromboembolism There have been postmarketing reports of venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products such as testosterone gel, 1.62%.