The use of Nebido is contraindicated in men with:
The use of Nebido in women is contraindicated.
(The following is an excerpt from the European Association of Urology guidelines on hypogonadism).2
Testosterone treatment is clearly contraindicated in men with advanced prostate cancer. A topic under debate is the use of testosterone treatment in hypogonadal men with history of prostate cancer and no evidence of active disease. So far only systematic reviews with a limited number of patients and a relatively short period of follow-up are available and indicate no increased risk for prostate cancer recurrence.4,5 According to a retrospective study on hypogonadal men with previous history of prostate cancer receiving testosterone following cancer diagnosis, treatment was not associated with increased overall or cancer-specific mortality, but testosterone treatment was more likely to be prescribed in patients undergoing radical prostatectomy for well-differentiated tumours.6 No randomised placebo-controlled trials are available yet to document its longterm safety profile in these patients.
Nebido is contraindicated in men with androgen-dependent carcinoma of the prostate or of the male mammary gland.
The fear of increased risk of heart attack and stroke was mainly caused by two high profile studies.7,8 The European licensing authority found that the signal for an increased cardiovascular risk associated with the use of testosterone was weak and inconclusive.9 Since the publication of these studies in 2013 / 2014, many new studies have refuted the alleged cardiovascular risks10-23, and support the position statement of the European licensing authority that testosterone therapy is not associated with increased risk of heart attack and stroke. To the contrary, many of the newer studies actually show reduced risk of cardiovascular events as well as reduced mortality.10-23
In patients suffering from severe cardiac, or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.
It should be noted that in a 2015 analysis of randomised, double-blind, placebo-controlled trials (RCTs) concluded that severe lower urinary tract symptoms, as well as untreated sleep apnoea, may not be absolute contraindications to testosterone replacement therapy. 24
Six new RCTs all show that testosterone replacement therapy in patients with LUTS does not worsen LUTS symptoms – measured by the validated International Prostate Symptom Score (IPSS) questionnaire – compared to placebo.25-30 Even in men with severe LUTS, no differences in IPSS were seen in men receiving testosterone replacement therapy vs. placebo.30 Notably, there was actually a small improvement in IPSS scores in the testosterone-treated group.30
Regarding untreated severe obstructive sleep apnoea (which was a contraindication in older guidelines), new RCTs show no worsening in sleep-related parameters after testosterone therapy vs. placebo.31,32 Also, in healthy men without obstructive sleep apnoea, testosterone therapy does not cause any adverse sleep related effects.25 Please refer to the SmPC for a full list of contraindications and precautions. Sleep apnoea has been reported under treatment with testosterone-containing preparations and pre-existing sleep apnoea may be potentiated. Urinary disorders are listed as adverse reactions in the SmPC.
The guidelines also cite severe, uncontrolled, or poorly controlled congestive heart failure as a relative contraindication to testosterone therapy. A placebo controlled trial of 41 hypogonadal men with stable congestive heart failure treated with injectable testosterone along with a standardised exercise regimen found significant improvements peak oxygen uptake (p<0.01) and leg strength (p<0.05) in the testosterone treated group from baseline.33 This study suggests that men with well-controlled congestive heart failure may be considered for testosterone therapy. However, the specific contraindication against testosterone therapy in men with uncontrolled congestive heart failure remains unexamined.
Please refer to the SmPC for a full list of contraindications and precautions.
Report Adverse Events
Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.mhra.gov.uk.
Adverse events should also be reported to Bayer plc, Tel: 01182063500, Fax: 01182063703, Email: email@example.com.
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Please report any quality complaint to Bayer Plc, Email: firstname.lastname@example.org