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- 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
- 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
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.
- In the clinical trial, the most commonly reported adverse reactions (incidence >3%) were application
site pruritus (17%), application site vesicles (6%), and back pain.
Insulin: Androgens may decrease blood glucose and insulin requirement in
Oral Anticoagulants: Changes in anticoagulant activity may be seen with
androgens. More frequent monitoring of International Normalized Ratio (INR) and prothrombin time is
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.
Models are for illustrative purposes only.