Androgel Warnings, Precautions, Pregnancy, Nursing, Abuse - Testosterone Gel

Androgel Warnings, Precautions, Pregnancy, Nursing, Abuse - Testosterone Gel

WARNINGS

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.

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

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.

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

6. The treatment of hypogonadal men with testosterone esters may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases.

7. ALCOHOL BASED GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING UNTIL THE GEL HAS DRIED.

Transfer of testosterone to another person can occur when vigorous skin-to-skin contact is made with the application site (see Clinical Studies). The following precautions are recommended to minimize potential transfer of testosterone from AndroGel®-treated skin to another person:

• Patients should wash their hands immediately with soap and water after application of AndroGel®.

• Patients should cover the application site(s) with clothing after the gel has dried (e.g. a shirt).

• In the event that unwashed or unclothed skin to which AndroGel® has been applied does come 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. In vitro studies show that residual testosterone is removed from the skin surface by washing with soap and water. 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.

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.

Advise patients to carefully read the information brochure that accompanies each carton of 30 AndroGel® single-use packets or 88 g AndroGel® Pump.

• AndroGel® should not be applied to the scrotum.

• AndroGel® should be applied once daily to clean dry skin.

• After application of AndroGel®, it is currently unknown for how long showering or swimming should be delayed. For optimal absorption of testosterone, it appears reasonable to wait at least 5-6 hours after application prior to showering or swimming. Nevertheless, showering or swimming after just 1 hour should have a minimal effect on the amount of AndroGel® absorbed if done very infrequently.

• Since alcohol based gels are flammable, avoid fire, flame or smoking until the gel has dried.

1. Hemoglobin and hematocrit levels should be checked periodically (to detect polycythemia) in patients on long-term androgen therapy.

2. Liver function, prostatic specific antigen, cholesterol, and high-density lipoprotein should be checked periodically.

3. To ensure proper dosing, serum testosterone concentrations should be measured (see DOSAGE AND ADMINISTRATION).

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: AndroGel® is not indicated for women and must not be used in women.

AndroGel® is not indicated for women and must not be used in women.

Safety and efficacy of AndroGel® in pediatric patients have not been established.