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) and testosterone gel are 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 levels but have gonadotropins in the normal or low range

Limitations of use:

Safety and efficacy of Testim and testosterone gel 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 and testosterone gel are 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 and testosterone gel 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 and testosterone gel. 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 HCP. Testim and testosterone gel 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 or testosterone gel-treated skin:

  • Children and women should avoid contact with unwashed or unclothed application site(s) in men using Testim or testosterone gel
  • Testim and testosterone gel 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 or testosterone gel
  • 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 or testosterone gel 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

Venous Thromboembolism: Venous thromboembolic (VTE) events, including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products, such as Testim or testosterone gel. Evaluate patients who report symptoms of DVT or PE. If a VTE event is suspected, discontinue treatment and initiate appropriate workup and management.

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 and testosterone gel, 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 and testosterone gel are 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 or testosterone gel may potentiate sleep apnea, especially in patients with risk factors such as obesity or chronic lung diseases

Hypercalcemia: Use Testim or testosterone gel 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 or testosterone gel 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 or testosterone gel

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

ADVERSE REACTIONS

Adverse Reactions: Most common adverse reactions (incidence ≥2% of the Testim/testosterone gel patients and greater than placebo) are application site reaction (2%, 4%, 3%) and increased hematocrit (1%, 2%, 0%) for Testim/testosterone gel 50 mg, Testim/testosterone gel 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 or testosterone gel to assess potential risks of cardiovascular disease and prostate cancer

TES-00335