Indication¹

AndroGel^® (testosterone gel) 1.62% CIII is an androgen 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’s 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 AndroGel 1.62% in males <18 years old have not been established.

Important Safety Information¹

• AndroGel 1.62% is contraindicated in men with breast cancer or known or suspected prostate cancer, and in women who are or may become pregnant, or are breastfeeding, as testosterone may cause fetal harm.
• Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening 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 with androgens as appropriate. Monitor prostate specific antigen (PSA) levels periodically.
• Avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization and should be brought to the attention of the healthcare provider. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus. AndroGel 1.62% should be promptly discontinued until the cause of virilization is identified.
• Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Monitor hematocrit prior to and periodically during treatment.
• AndroGel 1.62% is not indicated for use in women.
• Treatment with AndroGel 1.62% may lead to azoospermia; edema in patients with preexisting cardiac, renal, or hepatic disease or in patients taking adrenocorticotropic hormone (ACTH) or corticosteroids; gynecomastia; sleep apnea, especially in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
• Treatment with androgens may lead to serious hepatic effects. AndroGel 1.62% is not known to cause these adverse effects. Monitor liver function tests (LFTs) periodically.
• Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. Monitor lipid levels periodically.
• Androgens 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.
• Most common adverse reaction of AndroGel 1.62% (incidence ≥5%) is an increase in prostate specific antigen (PSA).

Indication²

AndroGel^® (testosterone gel) 1% 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy or toxic damage from alcohol or heavy metals; or Hypogonadotropic Hypogonadism (Congenital or Acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma or radiation.

Important Safety Information²

• AndroGel 1% is contraindicated in men with breast cancer or known or suspected prostate cancer; in women who are pregnant, may become pregnant, or are breastfeeding as testosterone may cause fetal harm; or in men with known hypersensitivity to any of the ingredients in AndroGel 1%, including alcohol and soy products.
• Patients with benign prostatic hyperplasia (BPH) treated with androgens are at increased risk for worsening signs and symptoms of BPH.
• Patients treated with androgens may be at increased risk for prostate cancer.
• Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel 1%-treated skin:
  • Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel.
  • Patients should wash their hands with soap and water after application.
  • Cover the application site with clothing after the gel has dried.
  • Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin contact of the application site with another person is anticipated.
  • Do not apply AndroGel 1% to the genitals.
• Signs of virilization in children and women and the possibility of secondary exposure to testosterone gel should be brought to the attention of the healthcare provider. Testosterone gel should be promptly discontinued until the cause of the virilization is identified.
• AndroGel 1% is not indicated for use in women.
• Treatment with androgens may lead to azoospermia; edema in patients with preexisting cardiac, renal or hepatic disease; gynecomastia; sleep apnea in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
• Monitor serum testosterone, prostate-specific antigen, hemoglobin, hematocrit, liver function test, and lipid levels periodically.
• Most common adverse reactions (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.