TESTIM® 1% (testosterone gel)

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Indication and Important Safety Information

Indication

Testim 1% (testosterone gel) is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

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 unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Androgens are contraindicated in men with cancer of the breast or known or suspected cancer of the prostate. Testim is not indicated for women and must not be used in women. Pregnant and nursing women should avoid skin contact with Testim application sites on men. Testosterone may cause fetal harm, or harm a breast-feeding baby.

Testim should not be used in patients with known hypersensitivity to testosterone or any of the ingredients in Testim, including soy.

Men treated with androgens may be at an increased risk for prostate cancer, or the development or worsening of benign prostatic hyperplasia.

Testim is not meant for use in women. If you are pregnant, may become pregnant, or are breast-feeding, Testim may harm your unborn or breast-feeding baby. Women who are pregnant or who may become pregnant should avoid contact with the area where Testim has been applied.

Virilization can occur in women and children secondarily exposed to testosterone. To minimize the potential for secondary exposure to testosterone from Testim-treated skin, patients should wash their hands thoroughly and immediately with soap and water after application of Testim and should cover the application site(s) with clothing after the gel has dried. Prior to any situation in which direct skin-to-skin contact is anticipated, patients should wash the application sites thoroughly with soap and water so as to remove any testosterone residue.

Other risks associated with the use of testosterone include: edema with or without congestive heart failure, gynecomastia, and potentiation of sleep apnea. Large doses of testosterone may suppress spermatogenesis.

The most common adverse events occurring with the use of Testim include: application site reaction, increase in hematocrit/hemoglobin, headache, and increase in blood pressure.

Please see Full Prescribing Information and Medication Guide

References:

Testim [Prescribing Information]. Malvern, PA: Auxilium Pharmaceuticals, Inc; 2009.
Steidle C, et al; North American AA2500 T Gel Study Group. AA2500 testosterone gel normalizes androgen levels in aging males with improvements in body composition and sexual function. J Clin Endocrinol Metab. 2003;88(6):2673-2681.
Dean JD, et al. Long-term effects of Testim 1% testosterone gel in hypogonadal men. Rev Urol. 2005;7(2):87-94.
Marbury T, et al. Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGel. Biopharm Drug Dispos. 2003;24(3):115-120.

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