Safety and Monitoring


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AndroGel is the #1-prescribed testosterone replacement therapy (TRT)⁴

Since 2001, more than 7 million prescriptions have been filled for AndroGel⁴

Proven safe over time:

AndroGel study results at 42 months

In clinical studies of AndroGel, mean serum PSA concentration increased by 0.26 ng/mL (P<.001) at 6 months with no significant increase over the next 36 months¹
Demonstrated no clinically significant increase in lipid levels with up to 42 months of use^15,16
At the 10-g dose, hematocrit/hemoglobin increased (P<.0001) at day 90 to above normal range with no further statistical increase over the next 36 months^15,16

The most frequent adverse events reported by ≥5% of patients associated with the consistent use of AndroGel included abnormal lab test, acne, prostate disorder, and application site reaction.

Monitoring:

The following table outlines recommended monitoring for patients on TRT:

PSA=prostate-specific antigen; DRE=digital rectal exam; BMD=bone mineral density; Hct=hematocrit; Hgb=hemoglobin; LFTs=liver function tests; LUTS=lower urinary tract symptoms
*All guidelines recommend annual monitoring following the first year of TRT.
† Monitor BMD every 2 years if considered an important clinical parameter for the patient.
‡ Clinicians must be mindful of interassay and intra-individual (biologic) variation when monitoring PSA over time. Baseline PSA measurement (eg, interassay variability increases with higher mean PSA concentrations; intra-individual variability increases with lower PSA concentrations) and assay platform used are factors that influence variability. Coefficients of variation can approximate up to 15% for each.
§ Following the initial 3-month PSA and DRE evaluation, men should be followed in accordance with updated prostate cancer detection guidelines based on age and race.

Benefits of AndroGel

Professional resources


		AndroGel is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. AndroGel is not indicated for use in women. Geriatric patients treated with androgens may be at an increased risk for the development of prostatic hyperplasia and prostatic carcinoma. The most frequent adverse events reported by ≥5% of patients associated with the consistent use of AndroGel included abnormal lab test, acne, prostate disorder, and application site reaction.

This information is intended for residents of the United States.
For international product information please visit us at http://www.solvay.com.
© 2007 Solvay Pharmaceuticals, Inc.