Androgel Special Precautions

Androgel should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other etiology, responsible for the symptoms, has been excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction etc.) and confirmed by 2 separate blood testosterone measurements. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.
Due to variability in laboratory values, all measures of testosterone should be carried out in the same laboratory. Androgel is not a treatment for male sterility or impotence.
Prior to testosterone initiation, 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 PSA) in patients receiving testosterone therapy at least once yearly 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.
Androgel 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, treatment with Androgel may cause severe complications characterised by oedema with or without congestive cardiac failure. In this case, treatment must be stopped immediately. In addition, diuretic therapy may be required. Androgel should be used with caution in patients with ischemic heart disease.
Testosterone may cause a rise in blood pressure and Androgel should be used with caution in patients with hypertension.
Beside laboratory tests of the testosterone concentrations in patients on long term androgen therapy the following laboratory parameters should be checked periodically: hemoglobin, hematocrit (to detect polycythaemia), liver function tests, and determination of lipids profile.
Androgel should be used with caution in patients with epilepsy and migraine as these conditions may be aggravated.
There are published reports of increased risk of sleep apnoea in hypogonadal subjects treated with testosterone esters, especially in those with risk factors such as obesity and chronic respiratory disease.
Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy. Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment. If the patient develops a severe application site reaction, treatment should be reviewed and discontinued if necessary.
The attention of athletes is drawn to the fact that this proprietary medicinal product contains an active substance (testosterone) which may produce a positive reaction in anti doping tests.
Androgel should not be used by women, due to possibly virilizing effects.
Potential testosterone transfer: If no precaution is 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 androgenization).
The physician should inform the patient carefully about the risk of testosterone transfer and about safety instructions (see as follows). Androgel 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 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, shower before any situation in which this type of contact is foreseen.
* for people not being treated with Androgel: 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.
According to in vitro absorption studies on testosterone conducted with Androgel, it seems preferable for patients to observe at least 6 hours between gel application and bathing or showering. Occasional baths or showers taken between 1 and 6 hours after application of the gel should not significantly influence the treatment outcome. To guarantee partner safety the patient should be advised for example to observe a long interval between Androgel application and sexual intercourse, to wear a T shirt covering the application site, during contact period or to shower before sexual intercourse.
Furthermore, it is recommended to wear a T shirt, covering the application site, during contact period with children, in order to avoid a contamination risk of children skill.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
Use in Pregnancy: Pregnant women must avoid any contact with Androgel application sites. In case of pregnancy of the partner, the patient must reinforce his attention to the precautions for use (see Use in Pregnancy & Lactation).