Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with the development of peliosis hepatis, cholestatic jaundice and hepatic neoplasms, including hepatocellular carcinoma (see PRECAUTIONS, Carcinogenesis). Peliosis hepatis can be a life-threatening or fatal complication. Testosterone is not known to produce these adverse effects.

Geriatric patients treated with androgens maybe at an increased risk for the development of prostatic hyperplasia.

Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of subclinical or clinical prostate cancer prior to initiation of testosterone replacement therapy, because testosterone therapy may promote the growth of existing subclinical foci of prostate cancer.²

In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men (see PRECAUTIONS, Carcinogenesis).

Edema, with or without congestive heart failure, may be a serious complication of androgen treatment in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.

Gynecomastia frequently develops and occasionally persists in patients being treated for hypogonadism.

The physician should instruct patients to report any of the following side effects of androgens:

· Too frequent or persistent erections of the penis
· Any nausea, vomiting, jaundice, or ankle swelling

Virilization of female sexual partners has been reported with male use of a topical testosterone solution. Topically applied creams leave as much as 90 mg residual testosterone on the skin. The occlusive backing film on Androderm (testosterone transdermal system) prevents the partner from coming in contact with the active material in the system. Transfer of the system to the partner is unlikely.

Changes in body hair distribution, significant increase in acne, or other signs of virilization of the female partner should be brought to the attention of a physician.

PATIENT INFORMATION

An information brochure is available for patients concerning the use of Androderm.

Advise patients of the following:

Androderm should not be applied to the scrotum.

Androderm should not be applied over a bony prominence or on a par of the body that could be subject to prolonged pressure during sleep or sitting. Application to these sites has been associated with burn-like blister reactions.

Androderm does not have to be removed during sexual intercourse, nor while taking a shower or bath.

Androderm systems should be applied nightly.

Skin burns have been reported at the patch site in several 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.

Hemoglobin and hematocrit should be checked periodically to detect polycythemia in patients who are receiving androgen therapy.

Liver function, prostate specific antigen, total cholesterol and HDL cholesterol should be checked periodically.

Animal Data: Testosterone has been tested by subcutaneous injection and implantation in mice and rats. The implant induced cervical-uterine tumors in mice, which metastasized in some cases. There is suggestive evidence that injection of testosterone into some strains of female mice increases their susceptibility to hepatoma. Testosterone is also known to increase the number of tumors and decrease the degree of differentiation of chemically induced carcinomas of the liver in rats.

Human Data: There are rare reports of hepatocellular carcinoma in patients receiving long-term therapy with androgens in high doses. Withdrawal of drugs did not lead to regression of the tumors in all cases.

Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia.

Geriatric patients and other patients with clinical or demographic characteristics that are recognized to be associated with an increased risk of prostate cancer should be evaluated for the presence of subclinical or clinical prostate cancer prior to initiation of testosterone replacement therapy, because testosterone therapy may promote the growth of existing subclinical foci of prostate cancer.²

In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.

Pregnancy Category X: (See Contraindications).

Teratogenic Effects: Androderm must not be used in women

Nursing Mothers: Androderm must not be used in women.

Pediatric Use: Androderm has not been evaluated clinically in males under 15 years of age.

REFERENCES

2. Schroeder FH. Androgens and carcinoma of the prostate. In Neischlag E, Behre HM, eds. Testosterone Action, Deficiency, Substitution. Berlin/Heidelberg: Springer-Verlag; 1990,245-260.

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