A clear reason for follow-up visits

Regularly monitoring adult male patients on testosterone therapy is important not only for titration, but for patient safety, treatment response, and to ensure proper application as well.

Monitor pre-dose morning serum total testosterone (TT) concentration1:

  • 14 and 28 days after starting treatment
  • Following dose adjustment
  • Periodically during treatment and titrate dose based on patient’s response to therapy

Monitoring patients using AndroGel 1.62%1

  • BPH:

    Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. Avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization. AndroGel 1.62% should be discontinued until the cause of virilization is identified
  • PSA:

    Monitor prostate specific antigen (PSA) levels periodically. Patients treated with androgens may be at increased risk for prostate cancer and should be evaluated prior to initiating and during treatment with androgens
  • Hematocrit and Hemoglobin:

    Monitor hematocrit prior to and periodically during treatment. Monitor hemoglobin periodically. Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. An increase in red blood cell mass may increase the risk of thromboembolic events
  • Deep vein thrombosis (DVT) and pulmonary embolism (PE):

    If a venous thromboembolism (VTE) is suspected, discontinue AndroGel 1.62% and initiate appropriate workup and management. VTE, including DVT and PE, has been reported in patients using testosterone products
  • Cardiovascular Risk:

    Some studies, but not all, have reported an increased risk of major adverse cardiovascular events (MACE) in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use AndroGel 1.62%
  • Liver Function:

    Monitor liver function tests (LFTs) periodically. Treatment with androgens may lead to serious hepatic effects. AndroGel 1.62% is not known to cause these adverse effects
  • Lipids:

    Monitor lipid concentrations periodically. Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy
  • Serum Calcium Concentrations:

    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

Review The Endocrine Society guidelines for recommendations on monitoring

Review The Endocrine Society guidelines for recommendations on monitoring


Overall monitoring of testosterone therapy3

  • At every visit, possible adverse events should be monitored
  • The Endocrine Society recommends the following standardized monitoring plan for patients receiving testosterone therapy

Baseline

  • Testosterone levels
  • Hematocrita
  • BMD of lumbar spine/femoral neckb
  • Digital rectal exam (DRE)c
  • PSAc

3-6 Months

  • Testosterone levels
  • Hematocrita
  • DREc
  • PSAc

Annually

  • Testosterone levels
  • Hematocrita

1-2 Years

  • BMD of lumbar spine/femoral neckb

aIf hematocrit is >54%, stop therapy until hematocrit decreases to a safe level; evaluate the patient for hypoxia and sleep apnea; reinitiate therapy with a reduced dose.

bAt baseline in men with severe androgen deficiency or low-trauma fracture, and after 1-2 years on treatment for hypogonadal men with osteoporosis or low-trauma fracture, consistent with regional standard of care.

cIn men 40 years of age or older with baseline PSA greater than 0.6 ng/mL, perform digital rectal examination and check PSA level before initiating treatment, at 3-6 months, and then in accordance with guidelines for prostate cancer screening depending on the age and race of the patient.

Safety considerations1

  • Avoid unintentional exposure of women or children to AndroGel 1.62%. Secondary exposure to testosterone can produce signs of virilization. Exposure of a pregnant woman to AndroGel may result in potential hazard to the fetus. AndroGel 1.62% should be promptly discontinued until the cause of virilization is identified.