Testoviron Depot

/ Bayer

Testoviron Depot 250 is injected intramuscularly. Experience shows that transitory reactions which occur in rare cases during or immediately after oily injections (urge to cough, coughing fits, respiratory distress) can be avoided by injecting the solution very slowly. Testosterone serum levels should be measured before initiating treatment, as well as during therapy. The injections must be administered very slowly. Care should be taken to inject Testoviron Depot 250 deeply into the gluteal muscle, while observing the usual precautions for intramuscular administration. Special care must be given to avoid intravasal injection. The intramuscular injection must be conducted immediately after opening the ampoule.  Testosterone replacement therapy for male hypogonadism in adults.
Initial treatment: The contents of one ampoule or one prefilled syringe are applied intramuscularly in intervals of 2 to 3 weeks.
Maintenance treatment: To maintain an adequate androgenic effect in adults, injections should be given in the recommended intervals of 2 to 3 weeks. Shorter or longer intervals between injections may be needed, depending on individual hormone requirements.
Inducing puberty in boys with delayed puberty: When used to induce puberty in boys, a dose of 50 to not more than 100 mg testosterone enanthate is administered over 4 to 6 months, followed by a 3-month pause in therapy. The treatment can be repeated if necessary (note: a 14-day regimen of 50 mg is recommended for the 100 mg/month dose).

Testosterone replacement therapy in male hypogonadism, in cases where testosterone deficiency has been confirmed on the basis of clinical and laboratory evidence Inducing puberty in boys with delayed puberty (pubertas tarda).

Hypersensitivity to the active substance or to any of the excipients listed. Androgen-dependent carcinoma of the prostate or male mammary gland, Past or existing liver tumours, Hypercalcaemia in cases of malignant tumours, Newborn infants, Small children, Women.

Elderly patients treated with androgens may be at increased risk of developing prostatic hyperplasia. There is no clear evidence that androgens actually cause prostate cancer, but androgens can potentiate the growth of existing prostate cancer. Existing prostate carcinoma should therefore be excluded before use of testosterone preparations. For the treatment of hypogonadism, Testoviron Depot may be used only if hypogonadism (hyper or hypogonadotropic) has been demonstrated and if other aetiology, responsible for the symptoms, has been excluded. Testosterone insufficiency must be clearly demonstrated in the clinical symptoms (regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction, etc.) and confirmed by two separate blood testosterone measurements. There is only little experience with the use of Testoviron Depot in patients over 65 years of age. At present, there is no consensus about age-specific testosterone reference values. However, it should be taken into account that physiological serum testosterone levels decrease with increasing age. In children, testosterone may accelerate bone maturation as a result of peripheral conversion to oestrogen, thereby reducing adult height. In longer-term or higher-dose administration, radiological bone age measurements should therefore be conducted at regular intervals. Testoviron Depot must not be used in women, as women may develop signs of virilisation, e.g. acne, hirsutism, voice changes (particular care is required in women professionally reliant on singing or speaking), depending on individual sensitivity to androgenic impulses. Testoviron Depot is not suitable for the treatment of male sterility.
Venous Thromboembolism: There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products, such as Testoviron Depot. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with Testoviron Depot and initiate appropriate workup and management.
Medical examination: Before the start of therapy with testosterone, all patients must undergo a detailed medical examination in order to exclude the risk of pre-existing prostatic cancer. In patients receiving testosterone therapy, careful and regular check-ups of the prostate gland and breast must be performed in accordance with currently established methods (digital rectal examination and monitoring of serum PSA) at least once yearly, or twice yearly in elderly patients and in patients at risk (with certain clinical or familial factors). In addition to laboratory checks on testosterone concentrations, the following laboratory parameters should also be checked periodically in patients before and during long-term androgen therapy: haemoglobin, haematocrit and liver function tests. Due to variability in laboratory values, all measuring of testosterone levels should be carried out in the same laboratory.
Tumours: Androgens may accelerate the development of sub-clinical prostatic cancer and benign prostatic hyperplasia. Testoviron Depot should be used with caution in cancer patients at risk of hypercalcaemia (and associated hypercalciuria), e.g due to bone metastasis; It is recommended that serum calcium levels be regularly monitored in these patients. Cases of benign and malignant liver tumours that can lead to life-threatening intra-abdominal bleeding have been observed following use of testosterone depot preparations.
Other diseases: In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, therapy with testosterone can cause serious complications, characterised by oedema, which may or may not be accompanied by congestive heart failure . In this case , therapy must be discontinued immediately. Caution should be exercised in patients predisposed to oedema, as treatment with androgens can exacerbate sodium retention. Studies on the efficacy and safety of this medicinal product have not been conducted in patients with impaired renal or hepatic function. Testosterone therapy must therefore be performed only with caution in these patients. The restrictions on the use of intramuscular injections that apply to patients with acquired or congenital blood coagulation disorders must be observed. Testoviron Depot should be used only with caution in patients with epilepsy or migraine, as it may aggravate these disorders. In diabetic patients treated with androgens who achieve normal plasma testosterone levels after testosterone therapy, there may be a reduction in blood glucose, and hence a decrease in the need for insulin. Certain clinical symptoms , such as irritability, nervousness, weight gain, persistent or frequent erections may indicate excessive androgen exposure and require a dose adjustment. Testoviron Depot should be permanently discontinued if symptoms of excessive androgen exposure persist or recur during therapy on the recommended dosing schedule. Pre-existing sleep apnoea may be exacerbated.
Administration: Like all oily solutions, Testoviron Depot must be injected precisely and very slowly via the intramuscular route. A pulmonary microembolism with oily solutions can lead to symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia or syncope. These reactions can occur during or immediately after the injection and are reversible. Treatment is usually carried out with supportive measures, e.g. with additional oxygen administration. The use of Testoviron Depot can lead to positive results in doping tests. Androgens such as those contained in Testoviron Depot are not suitable for enhancing muscular development in healthy individuals or for boosting physical performance. It is impossible to predict the health consequences of using Testoviron Depot as a doping agent; serious health risks cannot be ruled out.

Undesirable effects that may occur when using androgens the most commonly observed undesirable effects are injection site pain , injection-site redness, cough and/or dyspnoea during or immediately after the injection.
For full details see prescribing information.

Oral anticoagulants: Testosterone and its derivatives have been reported to increase the effect of oral anticoagulants. Patients receiving oral anticoagulants thus require close monitoring, especially at the beginning or end of androgen therapy. More frequent monitoring of prothrombin times and INR determinations is advised.
ACTH & corticosteroids: The concurrent administration of testosterone with ACTH or corticosteroids can promote oedema formation; therefore, these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema.
Phenobarbital: Phenobarbital increases the breakdown of steroid hormones in the liver (impaired efficacy is possible).
Other interactions: Androgens can increase insulin sensitivity and thereby reduce the doses of insulin or other antidiabetics needed for treatment.
Effects on laboratory tests: Androgens may decrease levels of thyroxine-binding globulin, thereby resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4 in the uptake test. However, free thyroid hormone levels remain unchanged. There is no clinical evidence of impaired thyroid function.

Fertility: Testosterone replacement therapy can reversibly suppress spermatogenesis.
Pregnancy & breast-feeding: Testoviron Depot is contraindicated in women; its use is prohibited in pregnant or breast feeding women.

In case of overdose, no special therapeutic measures are required other than discontinuing the medicinal product or reducing the dose.