Safety — Testogel® 40.5 mg, transdermal gel in sachet
CONTRAINDICATIONS1,2
Testogel® 40.5 mg, transdermal gel in sachet is contraindicated in:
- Cases of known or suspected prostatic cancer or breast carcinoma
- Cases of known hypersensitivity to the active substance or any of the excipients
ADVERSE REACTIONS2
The most frequently observed adverse drug reactions at the recommended dosage of gel per day were skin reactions: reaction at the application site, erythema, acne, and dry skin.
| Preferred Terms | ||
|---|---|---|
| MedDRA System Organ Class | Common Adverse Reactions (≥ 1/100 to < 1/10) | Uncommon Adverse Reactions (≥ 1/1000 to < 1/100) |
| Psychiatric disorders | Mood disorders | |
| Nervous system disorders | Dizziness, paraesthesia, amnesia, hyperaesthesia | |
| Vascular disorders | Hypertension | |
| Gastro-intestinal disorders | Diarrhoea | |
| Skin and subcutaneous tissue disorders | Alopecia, urticaria | |
| Reproductive system and breast disorders | Gynaecomastia (which may be persistent, is a common finding in patients treated for hypogonadism), mastodynia, prostatic disorders | Prostate abnormalities |
| General disorders and administration site conditions | Headache | |
| Investigations | Changes in laboratory tests (polycythaemia, lipids). Haematocrit increased, red blood count increased, haemoglobin increased | Haematocrit increased, Haemoglobin increased, red blood cell count increased |
SPECIAL WARNINGS AND PRECAUTIONS:2
- Testogel® 40.5 mg, transdermal gel in sachet 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
- In patients suffering from severe cardiac, hepatic or renal insufficiency 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
- Testosterone may cause a rise in blood pressure and Testogel® 40.5 mg, transdermal gel in sachet should be used with caution in men with hypertension
- Testosterone 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 (e.g. deep-vein thrombosis, pulmonary embolism, ocular thrombosis) 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
- Improved insulin sensitivity may be observed in patients treated with androgens and may require a decrease in the dose of antidiabetic medications
- With large doses of exogenous androgens, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH), which could possibly lead to adverse effects on semen parameters including sperm count
- This medicine should not be used by women, due to possible virilizing effects
- The attention of athletes is drawn to the fact that Testogel® 40.5 mg, transdermal gel in sachet contains an active substance (testosterone) which may produce a positive reaction in anti-doping tests
Please consult the Summary of Product Characteristics to view the contraindications, warnings, special precautions and the full list of adverse reactions associated with Testogel® 40.5 mg, transdermal gel in sachet.