TESTIM® 1% (testosterone gel) | Who Should Be Screened for Low Testosterone?

Who Should Be Screened for Low Testosterone?

There are a number of challenges in diagnosing hypogonadism in men. The signs and symptoms are often nonspecific to hypogonadism and are modified by age and comorbidities, making diagnosis of this disorder challenging.¹ Assessing your patients for low testosterone should include a combined approach that considers age, signs and symptoms, and presence of certain comorbidities such as:

Diabetes²
Erectile dysfunction³
Obesity²
High cholesterol²
Long-term use of opioid pain medications⁴
HIV^5,6

Physicians should be aware that these risk factors have been linked to a higher chance of having low testosterone. More rigorous screening of these patients for low testosterone may be indicated.

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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:

Bhasin S, et al. Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6):2536-2559.
Mulligan T, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006;60(7):762-769.
Bodie J, et al. Laboratory evaluations of erectile dysfunction: an evidence based approach. J Urol. 2003;169:2262-2264.
Daniell HW. Hypogonadism in men consuming sustained-action oral opioids. J Pain. 2002;3(5):377-384.
Dobs AS. Androgen therapy in AIDS wasting. Baillière's Clin Endocrinol Metab. 1998;12(3):379-390.
Grinspoon S, et al. Effects of androgen administration in men with the AIDS wasting syndrome: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1998;129(1):18-26.

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