Auxilium

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel.
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Helps restore testosterone levels in men with Low T

  • Helps men with hypogonadism return to the normal testosterone level range (~300 to 1000 ng/dL)
  • Provides patients with 50 mg of testosterone in each discreet, portable, premeasured tube
  • In a 90-day study of hypogonadal men, men using Testim 100 mg/day had the following improvements in some signs and symptoms of Low T at 1 and at 3 months:
    • increase in sex motivation
    • increase in spontaneous erections
    • increase in sexual desire
  • At 3 months:
    • increase in lean body mass (muscle)
    • decrease in body fat
    • decrease in fat mass
  • INDICATIONS AND USAGE

    Testim® (testosterone gel) is indicated for testosterone 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. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range
    • Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range

    Limitations of use:

    Safety and efficacy of Testim in males less than 18 years old have not been established.

    Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

    IMPORTANT SAFETY INFORMATION

     

    CONTRAINDICATIONS

    Testim is contraindicated in men with carcinoma of the breast or known or suspected prostate cancer and in women who are, or may become pregnant, or who are breastfeeding. Testim may cause fetal harm and serious adverse reactions to nursing infants

    WARNINGS AND PRECAUTIONS

    Worsening Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Monitor patients for worsening of signs and symptoms of BPH. Patients treated with androgens may be at an increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens

    Potential for Secondary Exposure to Testosterone: Avoid unintentional exposure of women or children to Testim. Secondary exposure to testosterone resulting in virilization of children and women has been reported. Signs of virilization and the possibility of secondary exposure should be brought to the attention of the healthcare provider. Testim should be discontinued until the cause of virilization is identified

    Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testim-treated skin:

    • Children and women should avoid contact with unwashed or unclothed application site(s) in men using Testim
    • Testim should only be applied to the upper arms and shoulders. The area of application should be limited to the area that will be covered by a short-sleeve T-shirt
    • Patients should wash their hands with soap and water immediately after applying Testim
    • Patients should cover the application site(s) with clothing (e.g., a T-shirt) after the gel has dried
    • Prior to situations in which direct skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue
    • In the event that unwashed or unclothed skin to which Testim was applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible

    Polycythemia: Increases of 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

    Use in Women: Due to lack of controlled evaluations in women and potential virilizing effects, Testim is not indicated for use in women

    Potential for Adverse Effects on Spermatogenesis: Large doses of exogenous administration of androgens, including Testim, may lead to azoospermia through suppression of spermatogenesis

    Hepatic Adverse Effects: Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) and long-term therapy with intramuscular testosterone enanthate have been associated with serious hepatic adverse effects, including life-threatening and fatal complications. Testim is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction and discontinue Testim until the cause is evaluated

    Edema: Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease who use androgens. In addition to discontinuation of the drug, diuretic therapy may be required

    Gynecomastia: Gynecomastia may develop and persist in patients treated for hypogonadism

    Sleep Apnea: Testim may potentiate sleep apnea, especially in patients with risk factors such as obesity or chronic lung diseases

    Hypercalcemia: Use Testim with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria)

    Lipids: Changes in serum lipid profiles may occur

    Decreased Thyroxine-binding Globulin: Testim may decrease concentrations of thyroxine-binding globulins

    Monitoring: Monitor serum testosterone, prostate specific antigen, hematocrit, serum calcium concentrations, International Normalized Ratio (INR), prothrombin time, and lipid concentrations periodically as recommended in the Prescribing Information. Changes may require dose adjustment or discontinuation of Testim

    Flammability: Alcohol-based products, including Testim, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until Testim has dried

    Testim is not interchangeable with other topical testosterone products

    ADVERSE REACTIONS

    Adverse Reactions: Most common adverse reactions (incidence ≥2% of the Testim patients and greater than placebo) are application site reaction (2%, 4%, 3%) and increased hematocrit (1%, 2%, 0%) for Testim 50 mg, Testim 100 mg, and placebo, respectively

    DRUG INTERACTIONS

    Insulin: Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients

    Oral Anticoagulants: Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended in patients taking warfarin

    Corticosteroids: Use of testosterone with corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease

    USE IN SPECIFIC POPULATIONS

    Geriatric use: There are insufficient long-term data in geriatric patients using Testim to assess potential risks of cardiovascular disease and prostate cancer

    TES-00335