Ongoing patient care behind every bottle
Regularly monitoring adult male patients on testosterone therapy is important not only for titration, but for patient safety, for treatment response, and to ensure proper application.
AndroGel 1.62% Monitoring Guidelines1
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
14 and 28 Days
3 and 6 Months
- Serum calcium concentration (for cancer patients)
After Dose Adjustment
- PSA = prostate specific antigen.
- LFTs = liver function tests.
- aAfter the first year of therapy, hematocrit can be measured on an annual basis.
- BPH: Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH
- 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. Hematocrit can be re-evaluated 3 to 6 months after initiation of therapy, and then annually thereafter. 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
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions. If abuse is suspected, check serum testosterone concentrations and counsel patients concerning the serious adverse reactions associated with abuse. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events.