Frequently asked
questions (FAQ)

What is the role of testosterone in the body?

Testosterone is well known for its role as the primary male sex hormone, promoting secondary sexual characteristics and the formation of reproductive tissues.

However, testosterone has many roles in helping to maintain the homeostasis of bodily processes, from cognition to cardiovascular health.¹

Find more information on the role of testosterone.

What is hypogonadism?

Male hypogonadism (also known as testosterone deficiency) is defined as a clinical and biochemical syndrome associated with advancing age and comorbidities. It is characterised by a deficiency in serum androgen levels and relevant signs and symptoms, including low mood, fatigue, reduced muscle mass and decreased libido.¹

More information about testosterone deficiency can be found here.

At what level of testosterone, in patients with symptoms of testosterone deficiency, should I consider treating with testosterone therapy?

Regarding the thresholds for treatment intervention in symptomatic men, the British Society for Sexual Medicine and International Society for Sexual Medicine guidelines recommend the following:^1,2

Refer to our when to treat section for further information

What is Testogel^®?

Testogel^® is a prescription only medicine that contains testosterone. It is indicated in adults as testosterone therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.^3,6

What does 16.2 mg/g gel relate to in the product name of Testogel^® 16.2 mg/g gel?

This simply means the quantity of testosterone (mg) that is delivered for every gram (g) of gel. There are 16.2 mg of testosterone per 1 g of gel.

Why is the formulation of Testogel^® 16.2 mg/g gel referred to as mg/g instead of %?

According to the Quality Review of Documents³ (QRD) recommendations on the expression of strength in the name of centrally authorised human medicinal products published in 2009 by the European Medicines Agency (EMEA), semi solid preparations in gel form should be expressed under the format ‘x mg/g’.

How does Testogel^® 40.5 mg, transdermal gel in sachet fit into the Testogel^® range?

Testogel^® 40.5 mg, transdermal gel in sachet has been introduced to replace Testogel^® 50 mg, transdermal gel in sachet, harmonising the Testogel^® range. Testogel^® 40.5 mg, transdermal gel in a sachet returns testosterone level within the normal range with a smaller, more concentrated volume. It is just as effective as the 16.2 mg/g gel found in the Testogel^® pump, giving patients the flexibility to easily switch between the pump and sachet.

Please note, if patients are going to interchange between pump and sachet, they should be made aware that the dosing differs.

The recommended daily dose of Testogel^® 40.5 mg is 1 x sachet, which is equivalent to 2 x Testogel^® 16.2 mg/g gel pump actuations.

How do I prescribe Testogel^®?

On prescribing systems, the name of the product will appear as brand and as a non-proprietary name. They may be shown as follows:⁵

• Brand description: Testogel^® 16.2 mg/g gel (testosterone) or Testogel^® 40.5 mg, transdermal gel in sachet
• Non–proprietary description: Testosterone 16.2 mg/g gel or Testosterone 40.5 mg

What is the recommended daily dose of Testogel^®?

The recommended dose is two pump actuations of Testogel^® 16.2 mg/g gel, or one sachet of Testogel^® 40.5 mg, transdermal gel in sachet, applied once daily.

The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding four pump actuations or two sachets (81 mg testosterone) per day.³

Please refer to the dosage section for more information.

How is Testogel^® supplied?

Testogel^® 16.2 mg/g gel is supplied in a multi-dose container with a metering pump that contains 88 g of gel and delivers a minimum of 60 doses. At the recommended dose of two pump actuations (40.5 mg of testosterone), the pump container should supply a minimum of 30 days treatment. Each actuation delivers 20.25 mg of testosterone in 1.25 g of gel.³

Testogel^® 40.5 mg, transdermal gel in a sachet, is supplied in sachets containing 40.5 mg testosterone in 2.5 g gel.

Where can I report any adverse events?

You can report side effects directly via the Yellow Card Scheme 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 0902 or email: pharmacovigilance@besins-healthcare.com.

By reporting side effects, you can help provide more information on the safety of this medicine.

What assessments should be carried out before initiating Testogel^® and what are the monitoring requirements after treatment initiation?

Testosterone deficiency should be diagnosed on the basis of:^1,3,8

• Signs and symptoms
• Two fasting total serum testosterone tests on separate occasions – the BSSM recommends these tests be carried out between 7am and 11am

Prior to testosterone therapy initiation, all patients must undergo a prostate specific antigen (PSA) test and a digital rectal examination (DRE) in order to exclude a risk of pre-existing prostate cancer.

Monitoring requirements of patients being treated with testosterone therapy:^3,8

• Testosterone levels should be monitored at baseline and at regular intervals during treatment
• Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels
• In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit (to detect polycythaemia), liver function tests, and lipid profile.

Please refer to warnings and contraindications of the SmPC for Testogel^® 16.2 mg/g gel or Testogel^® 40.5 mg, transdermal gel in a sachet, before initiating treatment.

How effective is Testogel^®?

Testogel^® 40.5 mg, transdermal gel in sachet contains the same effective 16.2 mg/g gel found in the Testogel^® pump, which has been assessed in a randomised placebo-controlled trial. The recommended dose of Testogel^® (40.5 mg, once daily) has been shown to be effective at helping men with TD reach a eugonadal total testosterone concentration.⁹ However, patients should be monitored regularly when receiving testosterone therapy to ensure they are on the correct dosage.⁸

Visit the efficacy page for more study information and results.

What are the application sites for Testogel^®?

Testogel^® should be applied to clean, dry, intact skin of the upper arms and shoulders. Do not apply Testogel^® to any other parts of the body.⁸

For more information on applying Testogel^®, consult the Method of administration section of the Testogel^® 16.2 mg/g gel SmPC or Testogel^® 40.5 mg, transdermal gel in sachet SmPC.

What precautions need to be taken to prevent possible transfer of Testogel^®?

You should inform the patient carefully about the risk of testosterone transfer to another person and about safety instructions. Testogel^® should not be prescribed in patients with a major risk of non-compliance.³

Specific precautions are recommended for both the patient and those not being treated. Please refer to the Special warnings and precautions section of the SmPC for Testogel^® 16.2 mg/g gel or Testogel^® 40.5 mg, transdermal gel in sachet.

What is the shelf-life of Testogel^®?

3 years.³