TESTAVAN

Posology Adult men The recommended starting dose of Testavan is 23 mg testosterone (five pump actuations) applied once daily. ). The serum testosterone level should be measured 2-4 hours after dosing approximately 14 days and 35 days after starting treatment or after a dose adjustment.

3 nmol/L (500 ng/dL), the daily Testavan dose may be increased by 5 pump actuations. 4 nmol/L (1050 ng/dL), the daily Testavan dose may be decreased by 5 pump actuations. 6 mg testosterone) dosage adjustment may be made if necessary.

Dose titration should be based on both serum testosterone levels and the existence of clinical signs and symptoms related to testosterone deficiency. Elderly Same dose as for adults. 4). Maximum recommended dose The maximum recommended dose is 69 mg testosterone per day, which is equivalent to 15 pump actuations.

Renal and hepatic impairment There are no dedicated studies undertaken to demonstrate the efficacy and safety of this medicinal product in patients with renal or hepatic impairment. 4). 2). Female population Testavan is not indicated for use in women.

Paediatric population Testavan is not indicated in children and has not been clinically evaluated in males under 18 years of age. Method of administration Transdermal use. Testavan is a gel, which should be applied to the upper arm and shoulder, using the applicator.

Patients should be instructed not to apply Testavan with fingers or hands. Once the gel has dried, cover the application site with clean clothing (such as a t- shirt). Before close physical contact with another person (adult or child), wash the application site with soap and water once the recommended time period (at least 2 hours) has passed and cover again with clean clothing.

Priming of new pump To ensure correct dosing, patients should be instructed to prime each new pump before using it for the first time by pressing the pump head all the way down over a tissue paper until gel appears. Discard the initial gel and safely throw away the used tissue paper.

Administration Testavan should be applied once daily at about the same time, preferably in the morning to clean, dry, intact skin of the upper arm and shoulder using the applicator. 2). To apply the gel after removal of the applicator lid, the pump head should be pressed all the way down over the applicator head.

Patients should be instructed to only make up to five pump actuations onto the applicator at a time. The applicator should be used to spread the gel evenly across the maximum surface area of one upper arm and shoulder, making sure not to get any gel on the hands.

When more than five pump actuations are required to achieve daily dose, the procedure is repeated to the other upper arm and shoulder. Dose Application method 23 mg (5 pump depressions) Apply five pump actuations to an upper arm and shoulder.

Up to 46 mg (Up to 10 pump depressions) Apply five pump actuations to an upper arm and shoulder. Repeat to apply the remaining up to five pump depressions to the opposite upper arm and shoulder. Up to 69 mg (Up to 15 pump depressions) Apply five pump actuations to an upper arm and shoulder.

Repeat to apply five pump depressions to the opposite upper arm and shoulder. Repeat again to apply the remaining up to five pump depressions to the initial upper arm and shoulder. Cleaning of the applicator After use, the applicator should be cleaned with a tissue and the protective lid restored on top of the applicator.

The used tissue paper should be safely thrown away and the product stored safely out of reach of children. Following administration If the gel was touched with the hands during the application procedure, patients should be instructed to wash their hands with water and soap immediately after applying Testavan.

Patients should be advised to let the application site dry completely before getting dressed. 4). Wear clothing that covers the application side at all times to prevent accidental transfer to others.

a. Summary of the safety profile The most commonly reported adverse reactions in phase 2 and phase 3 clinical trials lasting up to 9 months were application site reactions (4%) including: rash, erythema, pruritus, dermatitis, dryness, and skin irritation.

The majority of these reactions were mild to moderate in severity. b. Tabulated summary of adverse events Adverse drug reactions reported in phase 2 and phase 3 clinical trials with Testavan are listed in the following table. 000 to < 1/100); Testavan drug-related adverse reactions reported during clinical trials with more than one case (N=379) MedDRA System Organ Class Common (≥1/100 to <1/10) Uncommon (≥ 1/1,000 to < 1/100) General disorders and administration site conditions Application site reaction (including rash, erythema, pruritus, dermatitis, dryness, and skin irritation) Investigations Blood triglycerides increased/hypertriglyceridaemia, PSA increased, haematocrit increased, Haemoglobin increased Vascular disorders Hypertension Nervous System Disorder Headache According to literature and spontaneous reporting from testosterone gels, other known undesirable effects are listed in the below table: MedDRA System Organ Class Adverse Reactions – Preferred term Blood and lymphatic system disorders Polycythaemia, anaemia Psychiatric disorders Insomnia, depression, anxiety, aggression, nervousness, hostility Nervous system disorders Headache, dizziness, paraesthesia Vascular disorders Hot flushes (vasodilation), deep vein thrombosis Respiratory, thoracic and mediastinal disorders Dyspnoea, sleep apnoea Gastrointestinal disorders Nausea Skin and subcutaneous tissue disorders Various skin reactions may occur including acne, seborrhoea and balding (alopecia), sweating, hypertrichosis Musculoskeletal and connective tissue disorders Musculoskeletal pain, muscle cramps Renal and urinary disorders Urination impaired, urinary tract obstruction Reproductive system and breast disorders Gynaecomastia, erection increased, testis disorder, oligospermia, benign prostatic hyperplasia, libido changes (therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism), prostate abnormalities, prostate cancer*) General disorders and administration site conditions Asthenia, malaise, application site reaction.

High dose or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema; hypersensitivity reactions may occur. Investigations Weight increase, elevated PSA, elevated haematocrit, red blood cell count increased or elevated haemoglobin Metabolism and nutrition disorders Electrolyte changes (retention of sodium, chloride, potassium, calcium, inorganic phosphate and water) during high dose and/or prolonged treatment.

Hepatobiliary disorders Jaundice and liver function test abnormalities. * Data on prostate cancer risk in association with testosterone therapy are inconclusive. Because of the alcohol contained in the product, frequent applications to the skin may cause irritation and dry skin.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Testavan should be used only if male hypogonadism has been demonstrated and if other etiology, responsible for the symptoms, has been excluded before treatment is started. ) and confirmed by two separate blood testosterone measurements before initiating therapy with any testosterone replacement, including Testavan treatment.

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).

Testosterone levels should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. Certain clinical signs: irritability, nervousness, weight gain, prolonged or frequent erections may indicate excessive androgen exposure requiring dosage adjustment.

Androgens may accelerate the progression of sub-clinical prostate cancer and benign prostatic hyperplasia. Testavan 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. Testavan is not a treatment for male sterility or impotence. There is limited experience on the safety and efficacy of the use of Testavan in patients over 65 years of age.

Currently, there is no consensus concerning age specific reference values for testosterone. However, it should be taken into consideration that the physiologically testosterone serum levels are lower with increasing age. Testosterone may cause a rise in blood pressure and Testavan should be used with caution in men with hypertension.

In patients suffering from severe cardiac, hepatic or renal insufficiency, or ischaemic heart disease treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In this case, treatment must be stopped immediately.

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 to minimise the individual VTE risk. Testosterone should be used with caution in patients with ischemic heart disease, epilepsy and migraine as these conditions may be aggravated.

There are published reports of increased risk of sleep apnoea in hypogonadal men treated with testosterone esters, especially in those with risk factors such as obesity or chronic respiratory disease. If the patient develops a severe application site reaction, treatment should be reviewed and discontinued if necessary.

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile. Testavan should not be used in women due to possible virialising effects.

As washing after Testavan administration reduces testosterone levels, patients are advised not to wash or shower for at least 2 hours after applying Testavan. When washing occurs up to 2 hours after the gel application, the absorption of testosterone may be reduced.

Testavan contains propylene glycol, which may cause skin irritation. Testavan contains ethanol. 84 %w/w). It may cause a burning sensation on damaged skin. Alcohol based products including Testavan are flammable; therefore avoid fire, flame or smoking until the gel has dried.

g. growth of facial and/or body hair, acne, deepening of the voice, irregularities of the menstrual cycle in woman or premature puberty and genital enlargement in children) 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).

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: • use the cap applicator for hands-free administration to reduce the risk of secondary exposure to testosterone. • if the gel was touched with the hands during the application procedure, wash hands thoroughly 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 skin to skin contact with another person is foreseen. For people not being treated with Testavan: • in the event […]

1. • Known or suspected carcinoma of the breast or the prostate