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Assess serum testosterone levels at 3, 6 and 12 months after treatment initiation, and annually thereafter. Monitoring levels of total testosterone (TT), sex hormone binding globulin (SHBG), and albumin (to calculate bioavailable or FT) is required to ensure normal testosterone levels are being achieved.
For monitoring purposes, the BSSM recommends a therapeutic target in the mid to upper range (15–30 nmol/L).
Follow-up every 3 months might be necessary in patients with a suboptimal treatment response.
Monitor haematocrit before treatment, at 3–6 months, 12 months, and annually thereafter.
Decrease dosage, or switch preparation, if haematocrit is >0.54. If haematocrit remains high, consider stopping treatment, and reintroduce at a lower dose.
Follow-up every 3 months might be necessary in patients with high or increasing haematocrit levels.
Assess prostate health by prostate-specific antigen (PSA) and digital rectal examination (DRE) before initiating TTh. PSA should be determined at baseline, 3, 6 and 12 months, and then annually thereafter.
PSA increases greater than 1.4 ng/mL during any 1-year period after initiation of TTh or a PSA velocity greater than 0.4 ng/mL per year during sequential PSA measurements over more than 2 years warrant a urologic evaluation and more intensive surveillance for prostate cancer thereafter.
Follow-up every 3 months might be necessary in patients with high or increasing PSA levels.
Assess cardiovascular risk before TTh is initiated and monitor cardiovascular risk factors throughout therapy.
Although monitoring of serum lipids and glycemia is not required for safety during TTh, it could be necessary for monitoring the efficacy of other aspects of treatment.
Men with cardiovascular disease should be monitored carefully, with clinical assessment and measurement of testosterone and haematocrit levels performed regularly.
Testogel® 16.2 mg/g gel should be used with caution in patients with ischaemic heart disease.
Please note that treatment/monitoring guidelines are not a substitute for specific summary of product characteristics when initiating and monitoring testosterone therapy (TTh).
TES/2020/009. April 2021.
Adverse event reporting
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Besins Healthcare (UK) Ltd Drug Safety on 0203 862 0920 or Email: email@example.com
Starting a new treatment can be daunting for patients, help reassure them that support is available to them.