Presentation and Status in Health Basket
5 gr (in 30 unit-dose sachets)
Adults and elderly: The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily, at about the same time, preferably in the morning. The daily dose should be adjusted by the doctor depending on the clinical or laboratory response in individual patients, not exceeding 10 g of gel per day. The adjustment of posology should be achieved afby 2.5 g of gel steps. The application should be administered by the patient himself, onto clean, dry, healthy skin over the shoulders, arms and/or abdomen. After opening the sachet, the total content must be extracted from the sachet and applied immediately onto the skin. The gel has just to be simply spread on the skin gently as a thin layer. It is not necessary to rub in on the skin. Allow drying for at least 3-5 minutes before dressing. Wash hands with soap and water after applications. Do not apply to the genital areas as the high alcohol content may cause local irritation. Steady state plasma testosterone concentrations are reached approximately on the 2nd day of treatment with Androgel. In order to adjust the testosterone dose, serum testosterone concentrations must be measured in the morning before application from the 3rd day on after starting treatment (one week seems reasonable). The dose may be reduced if the plasma testosterone concentration is raised above the desired level. If the concentration is low, the dosage may be increased, not exceeding 10 g of gel per day.
Children: Androgel is not indicated for use for children and has not been evaluated clinically with males less than 18 years old.
Testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
In case of known or suspected breast carcinoma or prostatic cancer.
In case of known hypersensitivity to testosterone or any of the excipients.
NOTE: Secondary Exposure to Testosterone – Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
Androgel should be used only if hypogonadism (hyper- and hypogonadotrophic) has been demonstrated and if other etiology, responsible for the symptoms, has not 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 two 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 initiation a treatment containing testosterone, all patients must undergo a detailed examination in order to exclude any 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 by patients suffering from cancer and having a risk of hypercalcaemia (and associated hypercalciuria), due to bone metastases. Regular monitoring of serum calcium concentration is recommended in these patients. In patients suffering from severe cardiac, hepatic or renal insufficiency, treatment with Androgel may cause severe complications characterized 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 on increased risk of sleep apnea in hypogonadal patients 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 concentration following replacement therapy. 3 Certain clinical signs such as: irritability, nervousness, weight increase, prolonged or frequent erections may indicate excessive androgen exposure requiring a 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 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 possible virilizing effects. Human data: There are rare reports of hepatocellular carcinoma in patients receiving long-term oral therapy with androgens in high doses. Withdrawal of the drugs did not lead to regression of the tumours in all cases.
Potential to Secondary Exposure to Testosterone: If no precaution is taken, secondary exposure to testosterone in children and women can occur with testosterone gel use in men, resulting in increased testosterone serum levels and possibly adverse effects. Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of testosterone gel. (See 4.8 Undesirable effects). Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified. The physician should inform the patient carefully about the risk of testosterone transfer and about safety instructions (see below). Androgel should not be prescribed in patients with a major risk of noncompliance with safety instructions (e.g. severe alcoholism, drug abuse, severe psychiatric disorders).
Frequent: Skin reactions (10%) such as erythema, acne and dry skin. Other effects reported: Headaches, alopecia, gynecomastia, polycythemia, prostatic disorders, diarrhea, dizziness, asthenia, hypertension, mood disorders, changes in laboratory tests (polycythemia, etc.), reduced libido, hyperesthesia, paraesthesia.
For full details see prescribing information.
+ Oral anticoagulants: Changes in anticoagulant activity (the increased effect of the oral anticoagulant by modification of coagulation factors hepatic synthesis and competitive inhibition of plasma protein binding): increased monitoring of the prothrombin time and INR determinations are recommended. Patients receiving oral anticoagulants require close monitoring especially when androgens are started or stopped. Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements. Concomitant administration of testosterone with ACTH or corticosteroids may increase the risk of developing oedema. As a result, these medicinal products should be administered cautiously, particularly in patients with cardiac, renal or hepatic disease. Interaction with laboratory test: androgens may decrease levels of thyroxin binding globulin, resulting in decreased T4 serum concentrations and in increased resin uptake of T3 and T4. Free thyroid hormone levels, however, remain unchanged, and there is no clinical evidence of thyroid insufficiency
Pregnancy and Lactation
Androgel is intended for use by men only. Androgel is not indicated in pregnant or breast feeding women. No clinical trial has been conducted with this treatment in women. Pregnant women must avoid any contact with Androgel application areas. This product may have adverse virilizing effects on the foetus. In the event of contact, wash with soap and water as soon as possible.
Only one case of acute testosterone overdose following an injection has been reported in the literature. This was a case of a cerebrovascular accident in a patient with a high plasma testosterone concentration of 114 ng/ml (395 nmol/l). It would be most unlikely that such plasma testosterone concentrations be achieved using the transdermal route.