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INDICATION
  • ANDRODERM® 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 syndrome, chemotherapy, or toxic damage from alcohol or heavy metals
    • Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation
  • Important limitations of use: Safety and efficacy of ANDRODERM® in males less than 18 years old have not been established.
IMPORTANT SAFETY INFORMATION
Contraindications
  • ANDRODERM® is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • ANDRODERM® is contraindicated in women who are, or who may become pregnant, or who are breastfeeding. ANDRODERM® may cause fetal harm when administered to a pregnant woman. ANDRODERM® may cause serious adverse reactions in nursing infants.
Warnings and Precautions
  • Worsening of Benign Prostatic Hyperplasia and Potential Risk of Prostate Cancer: Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment. It is appropriate to reevaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices.
  • Polycythemia: Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events. Check hematocrit prior to initiating testosterone treatment. It is appropriate to reevaluate the hematocrit 3 to 6 months after starting testosterone treatment, and then monitor annually.
  • Venous Thromboembolism: There have been reports of venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products such as ANDRODERM®. 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, and if a VTE is suspected, discontinue ANDRODERM® and initiate appropriate workup and management.
  • Use in Women and Children: Avoid exposure of women or children to ANDRODERM®.
  • Potential for Adverse Effects on Spermatogenesis: Exogenous administration of testosterone may lead to azoospermia.
  • Hepatic Adverse Events: Prolonged use of high doses of orally active androgens has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Intramuscular testosterone enanthate has produced multiple hepatic adenomas. Although ANDRODERM® is not known to cause these adverse effects, liver function tests (LFTs) should be monitored periodically.
  • Edema: Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease.
  • Gynecomastia: Gynecomastia may develop and persist in patients being treated with androgens, including ANDRODERM®, for hypogonadism.
  • Sleep Apnea: ANDRODERM® may potentiate sleep apnea in some patients, especially those with risk factors such as obesity and chronic lung disease.
  • Lipids: Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.
  • Hypercalcemia: Androgens, including ANDRODERM®, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is recommended in these patients.
  • Decreased Thyroxine-binding Globulin: Androgens, including ANDRODERM®, may decrease total T4 serum concentration. Free thyroid hormone concentration remains unchanged with no clinical evidence of thyroid dysfunction.
  • Magnetic Resonance Imaging (MRI): Skin burns have been reported at the application site in patients wearing an aluminized transdermal system during a magnetic resonance imaging scan (MRI). Because ANDRODERM® contains aluminum, it is recommended to remove the system before undergoing an MRI.
Adverse Reactions
  • In the clinical trial, the most commonly reported adverse reactions (incidence >3%) were application site pruritus (17%), application site vesicles (6%), and back pain.
Drug Interactions
  • Insulin: Androgens may decrease blood glucose and insulin requirement in diabetic patients.
  • Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is recommended.
  • Corticosteroids: Use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease.

Please see full Prescribing Information.

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