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- AndroGel [package insert]. Marietta, GA: Unimed Pharmaceuticals, Inc.
- Swerdloff RS, Wang C, Cunningham G, et al; and Testosterone Gel Study Group. Long-term pharmacokinetics of transdermal testosterone gel in hypogonadal men. J Clin Endocrinol Metab. 2000;85(12):4500-4510.
- Mulligan T, Frick MF, Zuraw QC, Stemhagen A, McWhirter C. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006;60(7):762-769.
- IMS Health, National Prescription Audit, June 2000 - August 2008.
- Bhasin S, Cunningham GR, Hayes FJ, et al. Testosterone therapy in adult men with androgen deficiency syndromes: An Endocrine Society clinical practice guideline. J Clin Endocrinol Metab 2006;91(6):1995-2010.
- Data on file, Solvay Pharmaceuticals, Inc. Marietta, GA.
- Vermeulen A, Kaufman JM, Giagulli VA. Influence of some biological indexes on sex hormone-binding globulin and androgen levels in aging or obese males. J Clin Endocrinol Metab. 1996;81:1821-1826.
- Wang C, Swerdloff RS, Iranmanesh A, et al; and Testosterone Gel Study Group. Effects of transdermal testosterone gel on bone turnover markers and bone mineral density in hypogonadal men. Clin Endocrinol. 2001;54:739-750.
- Wang C, Swerdloff RS, Iranmanesh A, et al; and Testosterone Gel Study Group. Transdermal testosterone gel improves sexual function, mood, muscle strength, and body composition parameters in hypogonadal men. J Clin Endocrinol Metab. 2000;85(8):2839-2853.
- Wang C, Cunningham G, Dobs A, et al. Long-term testosterone gel (AndroGel) treatment maintains beneficial effects on sexual function and mood, lean and fat mass, and bone mineral density in hypogonadal men. J Clin Endocrinol Metab. 2004;89:2085-2098.
INDICATION
- AndroGel® (testosterone gel) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary Hypogonadism or Hypogonadotropic Hypogonadism.
IMPORTANT SAFETY INFORMATION
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel.
- Children should avoid contact with any unwashed or unclothed application sites in men using testosterone gel.
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
- AndroGel is contraindicated: in men with breast cancer or known or suspected prostate cancer; in women who are pregnant, may become pregnant, or are breastfeeding as testosterone may cause fetal harm; or in men with known hypersensitivity to any of the ingredients in AndroGel, including alcohol and soy products.
- Patients with benign prostatic hyperplasia (BPH) treated with androgens are at increased risk for worsening signs and symptoms of BPH.
- Patients treated with androgens may be at increased risk for prostate cancer.
- Strict adherence to the following precautions is advised in order to minimize the potential for secondary exposure to testosterone from AndroGel-treated skin:
| - | Children and women should avoid contact with unwashed or unclothed application site(s) of men using testosterone gel. |
| - | Patients should wash their hands with soap and water after application. |
| - | Cover the application site with clothing after the gel has dried. |
| - | Wash the application site thoroughly with soap and water prior to any situation where skin-to-skin-contact of the application site with another person is anticipated. |
| - | Do not apply AndroGel to the genitals. |
- Signs of virilization in children and women and the possibility of secondary exposure to testosterone gel should be brought to the attention of the healthcare provider. Testosterone gel should be promptly discontinued until the cause of the virilization is identified.
- AndroGel is not indicated for use in women.
- Treatment with androgens may lead to: azoospermia; edema in patients with preexisting cardiac, renal or hepatic disease; gynecomastia; sleep apnea in those with risk factors; changes in insulin sensitivity or glycemic control; and changes in anticoagulant activity.
- Monitor serum testosterone, prostate-specific antigen, hemoglobin, hematocrit, liver function test, and lipid levels periodically.
- Most common adverse reactions (incidence ≥5%) are acne, application site reactions, abnormal lab tests, and prostatic disorders.
Please see full Prescribing Information including boxed warning and Medication Guide.
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