Diagnosing Men With Hypogonadism

Prior to initiating Androderm®, confirm the diagnosis of
hypogonadism by ensuring that serum testosterone
concentrations have been measured in the morning on at
least 2 separate days and that these serum testosterone
concentrations are below the normal range.1

Measuring Serum Testosterone Concentration

How to Prescribe Androderm®

Androderm® is available in 2 strengths1

  • The recommended starting dose for Androderm®
    therapy is one 4 mg patch, applied nightly for 24 hours1
  • Androderm® 2 mg patches contain 9.7 mg
    of testosterone, delivering 2 mg per day
  • Androderm® 4 mg patches contain 19.5 mg
    of testosterone, delivering 4 mg per day
2 mg and 4 mg Androderm patches

Daily Dosage of Testosterone

Steady state of testosterone*

Androderm® is a self-contained transdermal patch that
provides a continuous daily dose of testosterone.1

When applied nightly, Androderm® results in maximum
concentrations of testosterone in the early morning and
minimum concentrations in the evening.2

*Summary of the pharmacokinetic profiles of total testosterone
in 35 patients completing 28 days of Androderm® 4 mg/day
treatment as a starting dose followed by a possible dose titration.
Androderm Delivers Steady State of Testosterone

Application

Androderm® offers 4 convenient application areas to help
minimize visibility. The patch can be applied on areas of the back,
abdomen, upper arms, and thighs.1

  • Androderm® should be applied nightly to clean, dry, unbroken skin1
  • The sites of application should be rotated with an interval of 7 days
    between applications to the same site1
  • Avoid application over bony prominences or on a part of the body
    that may be subject to prolonged pressure during sleep or sitting.
    Do not apply to the scrotum1
  • Androderm® does not have to be removed during sexual activity,
    nor while taking a shower or bath1
  • Patients should avoid swimming or showering for a minimum of
    3 hours following application of Androderm®1

Application site irritations may be prevented or reduced by:

  • Application of 0.1% triamcinolone acetonide cream to the skin
    before applying the Androderm® patch1
  • Application of an over-the-counter hydrocortisone cream after
    the patch is removed1
Androderm Application Sites

Apply Androderm® patches
to the areas in purple only.


4 mg Androderm patch
No need to cover the applied patch before skin-to-skin contact.1 The occlusive backing helps to prevent others from coming into contact with testosterone.1
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IMPORTANT SAFETY INFORMATION

Contraindications

ANDRODERM is contraindicated in:

INDICATIONS AND USAGE

ANDRODERM is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

Limitations of use

IMPORTANT SAFETY INFORMATION (cont’d)

Warnings and Precautions

Adverse Reactions

Drug Interactions

Please see full Prescribing Information

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IMPORTANT SAFETY INFORMATION

Contraindications

ANDRODERM is contraindicated in:

  • Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • 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.

INDICATIONS AND USAGE

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): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

Limitations of use

  • Safety and efficacy of ANDRODERM in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
  • Safety and efficacy of ANDRODERM in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION (cont’d)

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. Discontinue testosterone therapy if the hematocrit becomes elevated. Testosterone therapy may be restarted when the hematocrit decreases to an acceptable level.
  • 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.
  • Cardiovascular Risk: Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE) such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use ANDRODERM.
  • Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.
  • Use in Women and Children: Women and children should not use ANDRODERM. Use in women and children has not been studied with ANDRODERM.
  • Potential for Adverse Effects on Spermatogenesis: At large doses of exogenous androgens, including ANDRODERM, spermatogenesis may be suppressed through feedback of inhibition of pituitary follicle-stimulating hormone that could lead to adverse effects on semen parameters including reduction of sperm count.
  • 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. ANDRODERM is not known to cause these adverse effects.
  • 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 (6%).

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 and should be monitored, particularly in patients with cardiac, renal, or hepatic disease.

Please see full Prescribing Information