Included as part of the PRECAUTIONS section.

Worsening of BPH and Potential Risk of Prostate Cancer

• Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH.
• Patients treated with androgens may be at increased risk for prostate cancer. Evaluation of the patient for prostate cancer prior to initiating and during treatment with androgens is appropriate [see Warnings and Precaution, ADVERSE REACTIONS, and Nonclinical Toxicology].
•  Increases in serum PSA from baseline values were seen in approximately 18% of individuals in an open label study of 162 hypogonadal men treated with AndroGel for up to 42 months. Most of these increases were seen within the first year of therapy [see CONTRAINDICATIONS, Warnings and Precautions, ADVERSE REACTIONS, and Nonclinical Toxicology].

Potential for Testosterone Transfer to Others

Transfer of testosterone to others (including women and children) 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.
• Women and children should avoid skin contact with AndroGel application sites in males. Changes in body hair distribution, significant increase in acne, or other signs of virilization should be brought to the attention of a physician. AndroGel may cause fetal harm in a pregnant woman due to virilization of a female fetus [see Use in Specific Populations].

Use in Women

Due to lack of controlled evaluations in women and potential virilizing effects, Androgel is not indicated for use in women [see Use in Specific Populations].

Potential for Adverse Effects on Spermatogenesis

At large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count.

Hepatic Adverse Effects

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 intramuscular testosterone enanthate has produced multiple hepatic adenomas. AndroGel is not known to produce these adverse effects.

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.

Edema

Drugs in the androgen class may promote retention of sodium and water. Edema with or without congestive heart failure may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see ADVERSE REACTIONS].

Gynecomastia

Gynecomastia may develop and may persist in patients being treated with androgens, including AndroGel, for hypogonadism.

Sleep Apnea

The treatment of hypogonadal men with testosterone products may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases [see ADVERSE REACTIONS].

Laboratory Tests

• Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Increase in red blood cell mass may increase the risk for a thromboembolic event.
• Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy.
• 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.
• Androgens 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.

Flammable until Dry

• Alcohol Based Products including AndroGel are flammable; therefore avoid fire, flame or smoking until the gel has dried.

Patient Counseling Information

See (PATIENT INFORMATION)FDA-approved patient labeling

Potential Adverse Reactions with Androgens

Patients should be informed that treatment with androgens may lead to adverse reactions which include:

• Changes in urinary habits such as increased urination at night, trouble starting your urine stream, passing urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, being unable to pass urine and weak urine flow.
• Breathing disturbances, including those associated with sleep, or excessive daytime sleepiness.
• Too frequent or persistent erections of the penis.
• Nausea, vomiting, changes in skin color, or ankle swelling.

Instructions for Use of AndroGel

• Patients should be informed to apply AndroGel once daily (preferably in the morning) to clean, dry skin of the shoulders and upper arms and/or abdomen. To prevent transfer of AndroGel to others, patient should wash their hands after application and cover the application site with clothing.
• Advise patients that AndroGel is an alcohol based product and is flammable, therefore avoid fire, flame or smoking until the gel has dried.
• Counsel patients on the importance of adhering to all recommended monitoring by their healthcare professional.
• Advise patients to report any changes in their state of health, such as changes in urinary habits, breathing, sleep, and mood.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

Use In Specific Populations

Pregnancy

Pregnancy Category X: AndroGel is contraindicated during pregnancy or in women who may become pregnant. It is teratogenic and may cause fetal harm [see CONTRAINDICATIONS]. 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, AndroGel is contraindicated in nursing women because of the potential for serious adverse reactions in nursing infants [see CONTRAINDICATIONS].

Testosterone and other androgens may adversely affect lactation.

Pediatric Use

Safety and efficacy of AndroGel in males < 18 years old has not been established.

Geriatric Use

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing AndroGel to determine whether efficacy in those over 65 years of age differs from younger subjects. Additionally, there is insufficient long-term safety data in geriatric patients to assess the potential risks of cardiovascular disease and prostate cancer.

Renal or Hepatic Impairment

No formal studies were conducted involving patients with renal or hepatic insufficiencies.

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