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1. Men with benign prostatic hyperplasia (BPH) are at an increased risk for worsening of BPH. In addition, men treated with androgens may be at an increased risk for prostate cancer. 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).
2. Potential for Secondary Exposure to Testosterone
   • Secondary exposure to testosterone in children and women can occur with testosterone gel use in men. Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance of testosterone-containing gel products. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone. In a few cases, however, enlarged genitalia did not fully return to ageappropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the testosterone gel product.
   • Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician, and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified.
3. Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testim®-treated skin:
   • Children and women should avoid contact with Testim® application sites on the skin of men using Testim.
   • Testim® should only be applied to the shoulders or upper arms (area of application should be limited to the area that will be covered by the patient's short sleeve t-shirt).
   • Patients should wash their hands thoroughly and immediately with soap and water after application of Testim® .
   • Patients should cover the application site(s) with clothing (e.g., a shirt) after the gel has dried.
   • Prior to any situation in which skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
   • In the event that unwashed or unclothed skin to which Testim® has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible. Studies show that residual testosterone is removed from the skin surface by washing with soap and water.
4. Testim® should not be applied to the abdomen.
5. 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. Transdermal testosterone is not known to produce these adverse effects.
6. 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.
7. Gynecomastia occasionally develops and occasionally persists in patients being treated for hypogonadism.
8. The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

General

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

• Too frequent or persistent erections of the penis.
• Any changes in skin color, ankle swelling or unexplained nausea and vomiting.
• Breathing disturbances, including those associated with sleep.

Information for Patients

Advise patients to carefully read the Medication Guide that accompanies each carton of Testim® single-use tubes.

Advise Patients of the Following:

1. Men with known or suspected prostate or breast cancer should not use Testim® .
2. Secondary exposure to testosterone in children and women can occur with the use of testosterone gel products in men. Cases of secondary exposure to testosterone have been reported in children with signs and symptoms including enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior.
   Unexpected sexual development including inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections, and aggressive behavior in children, or changes in hair distribution, increase in acne, or other signs of testosterone effects in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel also should be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization is identified.
3. Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from Testim®-treated skin:
   • Children and women should avoid contact with Testim® application sites on the skin of men using Testim® .
   • Testim® should only be applied to the shoulders or upper arms (area of application should be limited to the area that will be covered by the patient's short sleeve t-shirt).
   • Patients should wash their hands thoroughly and immediately with soap and water after application of Testim® .
   • Patients should cover the application site(s) with clothing (e.g., a shirt) after the gel has dried.
   • Prior to any situation in which skin-to-skin contact is anticipated, patients should wash the application site(s) thoroughly with soap and water to remove any testosterone residue.
   • In the event that unwashed or unclothed skin to which testosterone gel has been applied comes in direct contact with the skin of another person, the general area of contact on the other person should be washed with soap and water as soon as possible. Studies show that residual testosterone is removed from the skin surface by washing with soap and water.

Also advise patients of the following:

• Testim® should not be applied to the scrotum, penis, or abdomen.
• Testim® should be applied once daily at approximately the same time each day to clean dry skin of the shoulders and/or upper arms.
• Washing or swimming may lessen testosterone levels; however, when washing occurs two or more hours post drug application, serum testosterone levels remain within the normal range.

Laboratory Tests

1. Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.
2. Liver function, prostate specific antigen (PSA), cholesterol, and high-density lipoprotein (HDL) should be checked periodically.
3. To ensure proper dosing, serum testosterone concentrations should be measured (see DOSAGE AND ADMINISTRATION).

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 oral 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.

Pregnancy Category X (see CONTRAINDICATIONS)

Teratogenic Effects

Testim® is not indicated for women and must not be used in women. Testosterone may cause fetal harm.

Nursing Mothers

Testim® is not indicated for women and must not be used in nursing mothers.

Pediatric Use

Safety and efficacy of Testim® in patients < 18 years old has not been established.

Last reviewed on RxList: 12/19/2011
This monograph has been modified to include the generic and brand name in many instances.