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Testosterone therapy
(TTh)

Safety of TTh

Cardiovascular

Based on existing evidence and prior to the publication of results from the gold-standard TRAVERSE study, it appears as though patients with a correct diagnosis of hypogonadism and normalisation of circulating testosterone from administration of testosterone therapy (TTh) have reduced cardiovascular (CV) events and CV death (MACE).1,2

The weight of current medical evidence from well performed studies supports that TESTOSTERONE when replaced to adequate NORMAL HEALTHY RANGE levels has no overall adverse effects on the cardiovascular system and has shown benefits in patients not suffering from existing severe cardiac, hepatic or renal insufficiency, or ischaemic disease.1

Please also refer to warnings and precautions for use in those with existing CV disease.

Fertility

TTh can impact male fertility by lowering sperm count. UK guidelines indicate that TTh should be contraindicated in men with an active desire to have children.8

TTh commonly interrupts or reduces spermatogenesis due to negative feedback on the hypothalamic-pituitary-testicular (HPT) axis.1,2

Risk of prostate cancer

Risk of prostate cancer

Guidelines from the European Association of Urology (EAU), the British Society for Sexual Medicine (BSSM), the International Consultation of Sexual Medicine (ICSM), the International Society of Sexual Medicine (ISSM), the Endocrine Society (ES), and the International Study of the Ageing Male (ISSAM) conclude that there is no compelling evidence that TTh is associated with an increased risk of prostate cancer.8

Please consult SmPC for full list of warnings and precautions.

Haematocrit

TTh may increase haematocrit levels. UK guidelines indicated that TTh should be contraindicated if haematocrit is >0.54.8

Haematocrit should be monitored before treatment, at 3-6 months, 12 months and annually thereafter. A decrease in TTh dosage or switching preparation may be required if haematocrit is >0.54. If haemocrit remains high, consider stopping TTh and reintroducing at a lower dose.8

References

  1. Corona G, Sforza A, Maggi M. Testosterone Replacement Therapy: Long-Term Safety and Efficacy. World J Mens Health. 2017;35(2):65–76.
  2. TRAVERSE – ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03518034. Accessed April 2021.
  3. Hackett G, Kirby M, Edwards D, et al. British Society for Sexual Medicine Guidelines on Adult Testosterone Deficiency, With Statements for UK Practice. J Sex Med. 2017;14(12):1504–1523.
  4. de Souza GL and Hallak J. Anabolic steroids and male infertility: a comprehensive review. BJU Int. 2011;108(11):1860–1865.

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: pharmacovigilance@besins-healthcare.com