|Tostran should not be used to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated and if other aetiologies responsible for the symptoms have not been excluded. Testosterone deficiency should be clearly demonstrated by clinical features and confirmed by two separate blood testosterone measurements before initiating therapy with any testosterone replacement, including Tostran treatment.For the time being there is no consensus concerning age specific reference values for testosterone. However it should be taken into consideration that the physiological serum levels of testosterone decrease with age. To ensure proper dosing, serum testosterone concentrations should be measured (see Section 4.2).Tostran is not indicated for treatment of male sterility or sexual impotence.Prior to initiation of testosterone replacement therapy, all patients must undergo a detailed examination in order to exclude a risk of pre-existing prostatic cancer. Careful and regular monitoring of the prostate gland and breast must be performed in accordance with recommended methods (digital rectal examination and estimation of serum prostate specific antigen (PSA)) in patients receiving testosterone therapy at least annually and twice yearly in elderly patients and at risk patients (those with clinical or familial factors).Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.Oedema with or without congestive heart failure may be a serious complication in patients with pre-existing cardiac, renal or hepatic disease. The treatment must be discontinued immediately if such complications occur. In addition, diuretic therapy may be required.There are no studies undertaken to demonstrate the efficacy and safety of this medicinal product in patients with renal or hepatic impairment. Therefore, testosterone replacement therapy should be used with caution in these patients.The treatment of hypogonadal men with testosterone may potentiate sleep apnoea in some patients, especially those with risk factors such as obesity or chronic lung disease.The following checks should be carried out periodically: full blood count (including haemoglobin and haematocrit to detect polycythaemia), lipid profile and liver function tests. Care should be taken in patients with skeletal metastases due to the risk of hypercalcaemia/hypercalcuria developing from androgen therapy. Regular monitoring of the serum levels of calcium in these patients is recommended.Testosterone may cause a rise in blood pressure and Tostran should be used with caution in men with hypertension.Tostran should be used with caution in patients with ischemic heart disease, epilepsy and migraine as these conditions may be aggravated.Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.General: certain clinical signs may indicate excessive androgen exposure requiring dosage adjustment. The physician should instruct patients to report any of the following:• Irritability, nervousness, weight gain. • Too frequent or persistent erections of the penis.• Any nausea, vomiting, changes in skin colour or ankle swelling.• Breathing disturbances, including those associated with sleep.If the patient develops a severe application site reaction, treatment should be reviewed and discontinued if necessary.Athletes should be informed that Tostran contains an active substance (testosterone), which may give positive results in a doping test. Androgens are not suitable for enhancing muscular development in healthy individuals or for increasing physical ability.Tostran should not be used in women due to possible virilising effects.|
Potential for transferIf no precautions are taken, testosterone gel can be transferred to other persons by close skin to skin contact, resulting in increased testosterone serum levels and possibly adverse effects (e.g. growth of facial and/or body hair, deepening of the voice, irregularities of the menstrual cycle) in case of repeat contact (inadvertent androgenisation).The physician should inform the patient carefully about the risk of testosterone transfer and about safety instructions (see below). Tostran should not be prescribed in patients with a major risk of non-compliance with safety instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders).This transfer is avoided by wearing clothes covering the application area or bathing or showering prior to contact.As a result, the following precautions are recommended:
For the patient:• wash hands with soap and water after applying the gel,• cover the application area with clothing once the gel has dried,• bathe or shower before any situation in which this type of contact is foreseen.
For the health care professional or carer:• disposable gloves should be used if a health care professional or carer needs to apply the testosterone gel to the patient,• the disposable gloves should be resistant to alcohols as the gel contains both ethanol and isopropyl alcohol, which facilitate the penetration of testosterone.
For people not being treated with Tostran:• in the event of contact with an application area which has not been washed or is not covered with clothing, wash the area of skin onto which testosterone may have been transferred as soon as possible, using soap and water, • report the development of signs of excessive androgen exposure such as acne or hair modification.To guarantee partner safety the patient should be advised for example to observe a minimum of four hours between Tostran application and sexual intercourse, to wear clothing covering the application site, during contact period or to bathe or shower before sexual intercourse.Furthermore, it is recommended to wear clothing covering the application site during contact periods with children, in order to avoid a risk of contamination to children's skin.Pregnant women must avoid contact with Tostran application sites. In case of pregnancy of a partner, the patient must take extra care with the precautions for use described above (see also Section 4.6).Absorption studies of testosterone conducted in patients treated with Tostran indicate that patients should wait at least two hours between gel application and bathing or showering.Tostran contains butylhydroxytoluene (E321) which may cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes. Tostran contains propylene glycol which may cause skin irritation.