Managing testosterone deficiency in clinical practice

For full prescribing information, including side effects, precautions and contraindications, please consult the Summary of Product Characteristics (SmPC).

Presentation: Transdermal gel in a multi-dose container, one pump actuation delivers 1.25g of gel containing 20.25mg of testosterone. Indication: Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. Dosage and administration: Transdermal use. The recommended dose is two pump actuations of gel (i.e. 40.5 mg of testosterone) applied once daily. The daily dose should not exceed four pump actuations (81 mg testosterone) per day. Adjustment of dosage should be achieved by increments of one pump actuation, usually based on measurements of blood testosterone levels and/or clinical response. The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders, or both arms. Allow to dry for at least 3–5 minutes before dressing. Do not apply to the genital areas as the high alcohol content may cause local irritation. Contraindications: Cases of known or suspected cancer of the prostate or breast, known hypersensitivity to testosterone or to any other constituent of the gel. Warnings and precautions for use: Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate blood testosterone measurements. Testosterone levels should be monitored at baseline and at regular intervals during treatment. In patients receiving long-term androgen treatment, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit (to detect polycythaemia), liver function tests, and lipid profile. Testogel may affect results of laboratory tests of thyroid function. Risk of pre-existing prostatic cancer should be excluded and the prostate gland and breast monitored during Testogel treatment. Testogel should be used with caution in cancer patients at risk of hypercalcaemia and associated hypercalciuria due to bone metastases; regular monitoring of blood calcium levels is recommended in these patients. Testogel may cause oedema with or without congestive cardiac failure in patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease. If this occurs, treatment must be stopped immediately. In addition, diuretic therapy may be required. Testogel should be used with caution in patients with ischaemic heart disease. Testosterone may cause a rise in blood pressure and should be used with caution in men with hypertension. Testogel should be used with caution in patient with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy. 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. Testogel should be used with caution in patients with epilepsy and migraine. Testogel may increase the risk of sleep apnoea, especially in patients who are obese or at risk of chronic respiratory disease. Gynaecomastia occasionally develops and occasionally persists. Irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.

This medicine contains ethanol and is flammable. Care should be taken to avoid sources of heat when administering the product, until the gel has dried on the skin. This medicine can be transferred to other persons by close physical contact resulting in increased testosterone serum levels and possibly adverse effects. Additional caution should be taken when using this product and in close physical contact with children as secondary transmission of testosterone through clothing cannot be excluded. The physician should inform the patient carefully about the risk of testosterone transfer. Before close physical contact with another person (adult or child), wash the application site with soap and water once the recommended time period (at least 1 hour) has passed and cover the site again with clean clothing. This product contains ethanol: in neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin. Testogel is not indicated for use in women or in children under 18 years of age. Interactions: Testogel may increase the activity of oral anticoagulants. Concomitant administration of testosterone and ACTH or corticosteroids may increase the risk of developing oedema. Testogel may cause changes in insulin sensitivity, glucose intolerance, glycaemic control, blood glucose and glycosylated haemoglobin levels. In diabetic patients, the dose of antidiabetic medications might need reduction. Monitoring of the glucose level and HbA1c is also recommended. Fertility, pregnancy and lactation: Pregnant women and women who are breast-feeding must avoid any contact with Testogel. This product may have adverse virilising effects on the foetus. Spermatogenesis may be reversibly suppressed with this medicine. This medicine is intended for men only. This medicine is not indicated in women who are breast-feeding. Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Undesirable effects: The most frequently observed clinical adverse drug reactions at the recommended dosage per day were skin reactions at the application site, (erythema, acne, dry skin), anxiety and asthenia. The following commonly (≥1/100; <1/10) occur with Testogel: mood disorders, emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido), dizziness, paraesthesia, amnesia, hyperaesthesia, hypertension, diarrhoea, alopecia urticaria, gynaecomastia, application site reaction, increased haematocrit, increased haemoglobin and increased red blood cell count. The following uncommonly (≥1/1000 to<1/100) occur with Testogel: malignant hypertension, flushing, phlebitis, oral pain, abdominal distention, acne, hirsutism, rash, dry skin, seborrhoea, skin lesions, contact dermatitis, hair colour changes, application site hypersensitivity, application site pruritus, nipple disorder, prostate-abnormalities, testicular pain, increased erection, pitting oedema and PSA increased. Rare (≥1/10,000 to <1/1,000): hepatic neoplasm. Frequency not known: prostate cancer. Please refer to the SmPC for further information. Overdose: Symptom may include application site rash. Serum testosterone levels should be measured if clinical signs and symptoms indicative of overexposure to androgen are observed.

Legal category: POM. Marketing Authorisation Number: PA 1054/002/004. Marketing Authorisation Holder: Laboratoires Besins International, 3 rue Bourg l'Abbe, 75003 Paris, France Date of preparation of Prescribing Information: February 2025 MAT-PROMO-TES-0135

Further information is available upon request or in the SmPC.

For full prescribing information, including side effects, precautions and contraindications, please consult the Summary of Product Characteristics (SPC)

Presentation: 5 g sachets containing 50 mg of testosterone. Indication: Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. Dosage and administration: Transdermal use. The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily. The daily dose should not exceed 10 g of gel per day (100 mg testosterone). Adjustment of dosage should be in steps of 2.5 g of gel, usually based on measurements of serum testosterone concentrations. The gel should be administered by the patient himself, onto clean, dry, healthy skin over both shoulders or both arms or the abdomen. Allow drying for at least 3–5 minutes before dressing. Do not apply to the genital areas as the high alcohol content may cause local irritation. Contraindications: Cases of known or suspected cancer of the prostate or breast, known hypersensitivity to testosterone or to any other constituent of the gel. Warnings and precautions for use: Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate blood testosterone measurements. Testosterone level should be monitored at baseline and at regular intervals during treatment. In addition, in patients receiving long-term androgen therapy, the following laboratory parameters should be checked regularly: haemoglobin, haematocrit (to detect polycythaemia), liver function tests and lipid profile. Testogel may affect results of laboratory tests of thyroid function. Risk of pre-existing prostatic cancer should be excluded and the prostate gland and breast must be monitored during Testogel treatment. Testogel should be used with caution in cancer patients at risk of hypercalcaemia and associated hypercalciuria due to bone metastases; regular monitoring of serum calcium concentrations is recommended in these patients. Testogel may cause oedema with or without congestive cardiac failure in patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease. If this occurs, treatment must be stopped immediately. In addition, diuretic therapy may be required. Testosterone may cause a rise in blood pressure and should be used with caution in patients with hypertension. Testogel should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy. 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. Irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment. Testogel should be used with caution in patients with epilepsy and migraine. Testogel may increase the risk of sleep apnoea, especially in patients who are obese or at risk of chronic respiratory disease.

This medicine contains ethanol and is flammable. Care should be taken to avoid sources of heat when administering the product, until the gel has dried on the skin. Additional caution should be taken when using this product and in close physical contact with children as secondary transmission of testosterone through clothing cannot be excluded. The physician should inform the patient carefully about the risk of testosterone transfer. Before close physical contact with another person (adult or child), wash the application site with soap and water once the recommended time period (at least 1 hour) has passed and cover the site again with clean clothing. This product contains ethanol: in neonates (pre-term and term newborn infants), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin. Testogel is not indicated for use in women or in children under 18 years of age. Interactions: May increase the activity of oral anticoagulants. Concomitant administration of testosterone and ACTH or corticosteroids may increase the risk of developing oedema. Changes in insulin sensitivity, glucose tolerance, glycaemic control, blood glucose and glycosylated haemoglobin levels have been reported with androgens. Therefore, in diabetic patients, the dose of antidiabetic medications may need to be decreased. Fertility, pregnancy and lactation: Spermatogenesis may be reversibly suppressed with this medicine. Pregnant women must avoid any contact with Testogel. This product may have adverse virilising effects on the foetus. This medicine is not indicated in women who are breast-feeding. Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed. Undesirable effects: The most frequently observed adverse drug reactions at the recommended dosage per day were skin reactions: reaction at the application site, (erythema, acne, dry skin) and emotional symptoms. The following commonly (≥1/100; <1/10) occur with Testogel: mood disorders, emotional symptoms (mood swings, affective disorder, anger, aggression, impatience, insomnia, abnormal dreams, increased libido), dizziness, paraesthesia, amnesia, hyperaesthesia, headache, hypertension, diarrhoea, alopecia, urticaria, gynaecomastia, application site reaction, haematocrit increased, haemoglobin increased, red blood cell count increased. The following uncommonly (≥1/1000 to<1/100) occur with Testogel: malignant hypertension, flushing, phlebitis, oral pain, abdominal distension, acne, hirsutism, rash, dry skin, seborrhoea, skin lesions, contact dermatitis, hair colour changes, application site hypersensitivity, application site pruritus, nipple disorder, prostate-abnormalities, testicular pain, increased frequency of erections, pitting oedema, PSA increased. Rare (≥1/10,000 to <1/1,000): hepatic neoplasm. Frequency not known: prostate cancer. Please refer to the SmPC for further information. In case of severe application site reactions, treatment should be reviewed and discontinued if necessary. Overdose: Symptom may include application site rash. Serum testosterone levels should be measured if clinical signs and symptoms indicative of overexposure to androgen are observed.

Legal category: POM. Marketing Authorisation Number: PA 1054/002/002. Marketing Authorisation Holder: Laboratoires Besins International, 3, rue du Bourg L'Abbe, 75003, Paris, France. Date of preparation of Prescribing Information: February 2025 MAT-PROMO-TES-0136

Further information is available upon request or in the SmPC.