This website has been developed by Besins Healthcare (UK) Ltd. This website has separate sections for healthcare professionals and patients who have been prescribed Testogel® 16.2 mg/g gel, within the UK.

Besins Healthcare is a pharmaceutical company specialising in the development of innovative drugs for the well-being of men and women throughout their life.

This website is provided for HCPs in the UK by Besins Healthcare (UK) Ltd.

Frequently asked
questions (FAQ)

Frequently asked questions

For full information regarding Testogel® 16.2 mg/g gel please refer to Testogel® 16.2 mg/g Summary of Product Characteristics.

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Couldn’t find the information that you were looking for? We’ve shared our most frequently asked questions. Simply search for your query below.

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

Treatment Diagram

Refer to our when to treat section for further information

What is Testogel® 16.2 mg/g gel?

Testogel® 16.2 mg/g gel 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.4

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

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 do I prescribe Testogel® 16.2 mg/g gel?

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)
  • Non–proprietary description: Testosterone 16.2 mg/g gel

What is the recommended daily dose of Testogel® 16.2 mg/g gel?

The recommended dose is two pump actuations of gel (i.e. 40.5 mg of testosterone) 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 81 mg testosterone per day.3

Refer to dosage for more information.

How is Testogel® 16.2 mg/g gel 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 2 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

Who should not use Testogel® 16.2 mg/g gel?

Testogel® 16.2 mg/g is contraindicated:3

  • Cases of known or suspected prostatic cancer or breast cancer
  • Hypersensitivity to testosterone or any of the excipients
  • An active desire to have children
  • Severe chronic heart failure

Testogel® should be used in caution with patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing reports of thrombotic events (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy.3

In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimise the individual VTE risk.3

Testogel® 16.2 mg/g should be used with caution in patients with ischaemic heart disease.

The safety and efficacy of Testogel® 16.2 mg/g in males under 18 years have not been established. Testogel® 16.2 mg/g gel is not indicated for use in women and must not be used in women who are or may become pregnant, or are breastfeeding.3

Refer to safety for more information.

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® 16.2 mg/g gel and what are the monitoring requirements after treatment initiation?

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

  • Signs and symptoms
  • Two fasting total serum testosterone tests on separate occasions 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.

Patients on testosterone should be monitored by:1,3,6

  • Serum testosterone should be checked at 2–4 weeks, 3–6 months and 12 months after therapy initiation
  • PSA test at 3–6 months after starting treatment and then annually
  • Haematocrit should be monitored before treatment, at 3-6 months, 12 months and annually thereafter
  • Haemoglobin, liver function and lipids should be monitored periodically

Please refer to warnings and contraindications of the SPC before initiating treatment with Testogel® 16.2 mg/g gel.

Are Testogel® 16.2 mg/g gel and Testogel® 50 mg, gel in sachet interchangeable?

No. Dosing and application sites for Testogel® 16.2 mg/g gel differ from Testogel® 50 mg and therefore the products are not interchangeable.3,7

How do I transition from Testogel® 50 mg to Testogel® 16.2 mg/g pump?

The recommended starting dose for Testogel® 50 mg Sachet is one sachet, for Testogel® 16.2 mg/g gel it is 2 actuations of the pump.

There are no comparative dosing studies that advise on how patients can be switched from one formulation of Testogel to the other. The guidance in the individual products’ summary of product characteristics should be followed when starting and titrating the dose of a particular Testogel formulation.3,7

For further information please refer to Testogel® 16.2 mg/g – Summary of Product Characteristics  and Testogel® 50 mg gel in sachet – Summary of Product Characteristics (SmPC).

What are the application sites for Testogel® 16.2 mg/g gel?

Testogel® 16.2 mg/g gel should be applied to clean, dry, intact skin of the upper arms and shoulders. Do not apply Testogel® 16.2 mg/g gel to any other parts of the body.3

For more information on applying Testogel® 16.2 mg/g gel consult the Applying Testogel® 16.2 mg/g gel section of the SPC.

What precautions need to be taken to prevent possible transfer of Testogel® 16.2 mg/g gel?

You should inform the patient carefully about the risk of testosterone transfer to another person and about safety instructions. Testogel® 16.2 mg/g gel 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 warnings and precautions section of the SPC.

What is the shelf-life of Testogel® 16.2 mg/g gel?

3 years.3

TES/2020/009. November 2020.

References

  1. 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.
  2. Men’s Health Review Panel. Men’s Health Handbook for General Practice. Toronto: MUMS Guideline Clearinghouse; 2019.
  3. Testogel® 16.2 mg/g gel – Summary of Product Characteristics (SmPC) – https://www.medicines.org.uk/emc/product/8919/smpc. Accessed April 2021.
  4. European Medicines Agency. 2010. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500056428.pdf. Accessed April 2021.
  5. National Institute for Health and Care Excellence (NICE). Testosterone, Gel. Available at:
    https://bnf.nice.org.uk/medicinal-forms/testosterone.html. Accessed April 2021.
  6. Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014;8:1010–112.
  7. Testogel® 50 mg gel in sachet – Summary of Product Characteristics (SmPC) – https://www.medicines.org.uk/emc/product/6808/smpc. Accessed April 2021.

TES/2020/009. November 2020.

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