Androgel Special Precautions

ANDROGEL 16.2 mg/g gel should only be used if hypogonadism (hypo- or hypergonadotrophic) has been demonstrated and if other aetiologies, which may be the cause of the symptoms, have been ruled out before starting the treatment. Testosterone insufficiency should be clearly demonstrated by clinical signs (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction, etc.) and confirmed by 2 separate blood testosterone assays. Currently, there is no consensus on age-based normal testosterone ranges. However, it should be taken into account that physiological blood testosterone values decrease with age.
Due to the variability of the outcomes between different laboratories, all assays must be performed by the same laboratory for a given subject.
ANDROGEL 16.2 mg/g gel is not indicated for the treatment of male sterility or impotence.
Before initiating a testosterone-based treatment, patients must undergo a thorough examination to rule out any risk of pre-existing prostate cancer. Careful and regular surveillance of the prostate and breasts should be carried out using the recommended methods (rectal examination and PSA-prostate-specific antigen assay) at least once a year in any patient receiving a testosterone treatment and twice a year in elderly subjects and patients at risk (clinical or family factors).
Androgens may accelerate the progression of subclinical prostate cancer or benign prostate hyperplasia.
ANDROGEL 16.2 mg/g gel should only used with caution in patients with cancer with a risk of hypercalcaemia (and associated hypercalciuria), related to bone metastases. It is recommended to ensure regular monitoring of blood calcium levels in these patients.
In patients with severe heart, liver, or kidney failure or ischemic heart disease, treatment with testosterone could lead to severe complications characterised by oedema, with or without congestive heart failure. In this case, the treatment should be discontinued immediately. In addition, diuretic treatment may be necessary.
ANDROGEL 16.2 mg/g gel should be used with caution in patients with ischemic heart disease.
Testosterone may cause blood pressure to increase. Therefore, ANDROGEL 16.2 mg/g should be used with caution in men with hypertension.
Blood clotting disorders: Testosterone should be used with caution in patients with thrombophilia or with risk factors for venous thromboembolism (VTE), as thromboembolic events have been reported in these patients while taking testosterone treatment, in studies and post-marketing follow-ups (e.g. deep vein thrombosis, pulmonary embolism, ocular thrombosis). In patients with thrombophilia, cases of VTE have been reported even while taking an anticoagulant treatment. Therefore, the continuation of the testosterone treatment after a first thrombotic event should be carefully evaluated. If the treatment is continued, further action should be taken to minimise the risk of VTE.
Testosterone levels should be monitored before starting treatment and at regular intervals during the treatment. Clinicians should adjust the dosage for each patient to ensure that the testosterone levels are maintained at a eugonadal level.
In patients on long-term androgen treatment, in addition to the biological assays of blood testosterone levels, the following laboratory parameters should be monitored regularly: haemoglobin levels, haematocrit (to detect polycythaemia), liver function, and lipid panel.
There is limited experience on the safety and efficacy of ANDROGEL 16.2 mg/g gel used in patients over 65 years of age. Currently, there is no consensus on baseline testosterone values based on age. However, the decrease in the physiological values of testosterone with age should be considered.
ANDROGEN 16.2 mg/g, gel should be used with caution in patients with epilepsy and migraine, as their condition may be aggravated.
Literature has reported risks of increased sleep apnoea during treatment with testosterone esters in subjects treated for hypogonadism, particularly in at-risk subjects with obesity or a chronic respiratory disease.
Improvement in insulin sensitivity may be observed in patients treated with androgens and may require a reduction in the dose of antidiabetic drugs.
Some clinical signs such as irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring a dosage adjustment.
In case of severe reaction at the application site, treatment should be reconsidered and stopped if necessary.
With high doses of exogenous androgens, spermatogenesis may be suppressed through feedback of the pituitary follicle-stimulating hormone (FSH), potentially leading to adverse effects on semen parameters including sperm count.
Gynaecomastia may sometimes develop and persist in patients treated with androgens for hypogonadism. ANDROGEL 16.2 mg/g, should not be used in women due to possible virilising effects.
The attention of athletes should be drawn to the fact that this medicine contains an active ingredient (testosterone) that can induce a positive reaction to tests performed during anti-doping controls.
Risk of inadvertent testosterone transfer: If no precautions are taken, testosterone can be transferred to another person at any time after dosing by close skin contact with the area where the gel is applied, leading to an increase in testosterone levels and, in the event of repeated contact (inadvertent androgenisation), possible adverse effects (for example, growth of facial and/or body hair, deepening of the voice, irregularities in the menstrual cycle in women, and premature puberty and organ development in children). If virilisation occurs, testosterone treatment should be promptly discontinued until the cause of the virilisation has been identified.
The doctor should inform the patient about this risk of testosterone transfer and about the precautions for use (see as follows). ANDROGEL 16.2 mg/g, gel should not be prescribed in patients at major risk of non-compliance with the precautions for use (e.g. severe alcoholism, drug use, severe psychiatric disorders).
The possible risk of transfer is substantially reduced (but not eliminated) by wearing clothes (such as a sleeved shirt) covering the application area. Most residual testosterone is removed from the skin surface by washing with soap and water before contact.
Therefore, the following precautions are recommended: For the patient: Wash hands with soap and water after applying the gel, cover the application area with clothing (such as a sleeved shirt) after the gel has dried, have a shower and wash the application site(s) thoroughly with soap and water to remove any testosterone residue before any situation in which such contact is anticipated.
For people not treated with ANDROGEL 16.2 mg/g: In the event of contact with an application area that has not been washed or is not covered with clothing, wash the skin surface on which testosterone transfer may have occurred with soap and water as soon as possible; report the appearance of signs of androgenisation such as acne or changes to hair.
To improve partner safety, the patient should be informed, for example, to wash the application area with soap and water before sexual intercourse or, if this is not possible, wear clothing, such as a T-shirt, covering the application site during the period of contact.
In addition, it is recommended to wear clothing covering the application site (such as a sleeved shirt) during contact periods with children to reduce the risk of contacting the children's skin.
Pregnant women must avoid contact with the application sites of ANDROGEL 16.2 mg/g, gel. In the case of pregnancy of a partner, the patient must be especially vigilant regarding the precautions for use.
This medicine contains 0.9 g of alcohol (ethanol) per 1.25 g measure of gel. This may cause a burning sensation on damaged skin.
This medicinal product may be flammable until the product dries.