IMPORTANT SAFETY INFORMATION
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
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.
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%).
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 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.
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