Androgel

/ CTS

Cutaneous use 
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.

This medicine 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.
Prior to testosterone initiation, 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.
This medicine should be used with caution in cancer patients at 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 or ischemic heart disease, treatment with with testosterone may cause severe complications characterized 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 this medicine 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 tominimise the individual VTE risk.
Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and hematocrit (to detect polycythaemia), liver function tests, and lipids profile.
There is limited experience on the safety and efficacy of the use of this medicine in patients over 65 years of age. 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.
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This medicine 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 apnoea in hypogonadal patients treated with testosterone esters, especially in those with risk factors such as obesity and chronic respiratory disease.
Improved insulin sensitivity may be observed in patients treated with androgens and may require a descrease in thedose of antidiabetic medications . Monitoring of the glucose level and HbA1c is advised for patientstreated with androgens.
Certain clinical signs such as: 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 medicinal product contains an active substance (testosterone) which may produce a positive reaction in anti-doping tests.
This medicine should not be used by women, due to possible virilizing effects.
Potential testosterone transfer
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 repeated contact (inadvertent androgenization).
The physician should inform the patient carefully about the risk of testosterone transfer, for instance during close bodily contact between individuals including children and about safety instructions (see below).
When prescribing, the treating physician should give extra attention to the section in the SmPC “Potential testosterone transfer” to patients with a major risk of not being able to follow these instructions.
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
• wash the application area before any situation in which close contact is foreseen
For people not being treated with the product:
• In the event of adventitious contact with this medicine, the person affected should wash the affected area with soap and water, immediately
• Report the development of signs of excessive androgen exposure such as acne or hair modification.
Patients should wait at least 1 hour before showering or bathing after applying this medicine.
Pregnant women must avoid any contact with this medicine application sites. In case of pregnancy of the partner, the patient must reinforce his attention to the precautions for use.
This medicine contains 3.6 g alcohol (ethanol) in each sachet.
It may cause burning sensation on damaged skin.
This product is flammable until dry.

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.
Diabetic medication
Improved insulin sensitivity, glucose tolerance, glycaemic control, blood glucose and glycosylated haemoglobin levelshave been reported with androgens. In diabetic patients, the dose of antidiabetic medications may need reduction.

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.

Symptoms
Serum testosterone levels should be measured if clinical signs and symptoms indicative of over exposure to androgen are observed. Application site rash has also been reported in case reports of overdose with this medicine.
Treatment
Treatment of over dosage consists of washing the application site immediately and discontinuing treatment if advised by the treating physician.