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. Evaluate patients for prostate cancer prior to initiating treatment. It is appropriate to re-evaluate patients 3 to 6 months after initiation of treatment, and then in accordance with prostate cancer screening practices [see Contraindications (4) ].
Polycythemia
Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating testosterone treatment. It is appropriate to re-evaluate 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. An increase in red blood cell mass may increase the risk of thromboembolic events.
Venous Thromboembolism
There have been postmarketing reports of venous thromboembolic events, 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. If a venous thromboembolic event is suspected, discontinue treatment with ANDRODERM and initiate appropriate workup and management [see Adverse Reactions ].
Use in Women and Children
Women and children should not use ANDRODERM. Use in women and children has not been studied with ANDRODERM.
Due to lack of controlled studies in women and potential virilizing effects, ANDRODERM is not indicated for use in women and children [see
Contraindications (4)
and
Use in Specific Populations (8.1
,
8.3
,
8.4
)].
Potential for Adverse Effects on Spermatogenesis
At large doses of exogenous androgens, including ANDRODERM, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) that could lead to adverse effects on semen parameters including reduction of sperm count.
Hepatic Adverse Effects
Prolonged use of high doses of orally active 17-alpha-alkyl androgens (methyltestosterone) 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. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. ANDRODERM is not known to cause these adverse effects.
Edema
Androgens, including ANDRODERM, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease [see Adverse Reactions (6) ].
Gynecomastia
Gynecomastia may develop and persist in patients being treated with androgens, including ANDRODERM, for hypogonadism.
Sleep Apnea
The treatment of hypogonadal men with testosterone 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 concentrations of thyroxine-binding globulins, resulting in decreased total T4 serum concentration and increased resin uptake of T3 and T4. Free thyroid hormone concentration remains unchanged and there is 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.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category X [see Contraindications (4)
] — ANDRODERM is contraindicated during pregnancy or in women who may become pregnant. Testosterone is teratogenic and may cause fetal harm. Exposure of a female fetus to androgens may result in varying degrees of virilization. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.
Nursing Mothers
Although it is not known how much testosterone transfers into human milk, ANDRODERM is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants. Testosterone and other androgens may adversely affect lactation [see Contraindications (4) ].
Pediatric Use
Safety and efficacy of ANDRODERM have not been established in males <18 years of age. Improper use may result in acceleration of bone age and premature closure of epiphyses.
Geriatric Use
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing ANDRODERM to determine whether efficacy in those over 65 years of age differs from younger patients. Additionally, there are insufficient long-term safety data in geriatric patients utilizing ANDRODERM to assess a potential incremental risk of cardiovascular disease and prostate cancer.
Renal Impairment
No studies were conducted in patients with renal impairment.
Hepatic Impairment
No studies were conducted in patients with hepatic impairment.
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