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- Patient Information:
Details with Side Effects
1. Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., 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 testosterone enanthate, which elevates blood levels for prolonged periods, has produced multiple hepatic adenomas. Testosterone is not known to produce these adverse effects.
3. 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 prostate cancer prior to initiation of testosterone replacement therapy. In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men (see
PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility and Laboratory Tests).
4. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required.
6. There are literature reports that the treatment of hypogonadal men with testosterone esters may potentiate sleep apnea in some patients,1,2 especially those with risk factors such as obesity or chronic lung diseases.3,4,5
The physician should instruct patients to report any of the following:
- Too frequent or persistent erections of the penis.
- Any nausea, vomiting, changes in skin color, or ankle swelling.
- Breathing disturbances, including those associated with sleep.
Virilization of female partners has been reported with use of a topical testosterone solution. Percutaneous creams leave as much as 90 mg residual testosterone on the skin. The results from one study indicated that, after removal of a TESTODERM (testosterone (transdermal)) system, the potential for transfer of testosterone to a sexual partner was 6 mc g, 1/45th the daily endogenous testosterone production by the female body. TESTODERM (testosterone (transdermal)) TTS, unlike TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE, has an occlusive backing that prevents the partner from coming in contact with the active material in the system. If a TESTODERM (testosterone (transdermal)) TTS system is inadvertently transferred to a female partner, it should be removed immediately and the contacted skin washed. Changes in body hair distribution or significant increase in acne of the female partner should be brought to the attention of a physician.
Information for Patients
An information brochure containing instructions for the use of TESTODERM (testosterone (transdermal)) TTS is available. A separate instruction booklet is available for TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE. These booklets contain important information and instructions on how to properly use and dispose of the TESTODERM (testosterone (transdermal)) products. Patients should be encouraged to ask questions of the physician and pharmacist.
Advise patients of the following:
- TESTODERM (testosterone (transdermal)) TTS should not be applied to the scrotum.
- TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only.
- The TESTODERM (testosterone (transdermal)) products should be applied once daily to dry, clean skin. If the TESTODERM (testosterone (transdermal)) product has come off after it has been worn for more than 12 hours and it cannot be reapplied, the patient may wait until the next routine application time to apply a new system.
- Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.
- Liver function, prostatic specific antigen, cholesterol, and high-density lipoprotein should be checked periodically.
- To ensure proper dosing, serum testosterone concentrations may be measured (see DOSAGE AND ADMINISTRATION ).
Anticoagulants: C-17 substituted derivatives of testosterone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.
Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
Propranolol: In a published pharmacokinetic study of an injectable testosterone product, administration of testosterone cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.7
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal Data: Testosterone has been tested by subcutaneous injection and implantation in mice and rats. In mice, the implant induced cervical-uterine tumors, 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 the 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 and prostatic carcinoma.
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 prostate cancer prior to initiation of testosterone replacement therapy.
In men receiving testosterone replacement therapy, surveillance for prostate cancer should be consistent with current practices for eugonadal men.
Teratogenic Effects: The TESTODERM (testosterone (transdermal)) products are not indicated for women and must not be used in women.
The TESTODERM (testosterone (transdermal)) products are not indicated for women and must not be used in women.
Safety and efficacy of the TESTODERM (testosterone (transdermal)) products in pediatric patients has not been established.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Testoderm Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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