Generic Name and Formulations:
Testosterone 2mg/day, 4mg/day; transdermal system.
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Not established in men with age-related hypogonadism.
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. ≥18yrs: initially apply one 4mg/day system nightly for 24hrs to intact clean, dry skin of the back, abdomen, thighs, or upper arms. Do not apply to scrotum; avoid bony prominences and areas subject to pressure during sleep or sitting. Rotate application sites at intervals of 7 days. Increase to 6mg (one 4mg/day + one 2mg/day system) or decrease to 2mg (one 2mg/day system) based on confirmed AM serum testosterone concentrations. Switching from 2.5mg/day, 5mg/day or 7.5mg/day systems: see full labeling.
<18yrs: not established.
Male breast or prostate cancer. Pregnancy (Cat.X). Nursing mothers.
Not for use in women. Monitor for worsening of signs/symptoms of BPH. Increased risk of prostate cancer; evaluate before starting therapy, at 3–6 months after, and then as necessary. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Preexisting cardiac, renal or hepatic diseases. Obesity. Chronic lung disease. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia). Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Remove system prior to undergoing MRI.
May alter insulin sensitivity and glycemic control. May affect oral anticoagulants; monitor INR, PT frequently. Increased fluid retention with concomitant ACTH, corticosteroids; monitor. May affect thyroid levels. Transdermal absorption reduced by pretreatment of triamcinolone ointment form.
Application site reactions (eg, pruritus, vesicles), back pain, chills, diarrhea, fatigue, GERD; polycythemia, edema, gynecomastia, sleep apnea, reduced sperm count, virilization in children.
Systems 2mg/day—60; 4mg/day—30
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