Testoviron Depot

/ Bayer

Serum testosterone levels must be measured before the start and during initiation of therapy. Serum levels below the normal range would indicate that the injection interval must be shortened. If serum levels are excessive, prolongation of the injection interval can be considered.
To achieve low dose levels, corresponding aliquots (0.2 mL equivalent to 50 mg testosterone enantate, 0.4 mL equivalent to 100 mg testosterone enantate, etc.) must be removed from the 250 mg testosterone enantate ampoule using a 1 mL injection syringe with 0.01 mL graduations. The injections must be administered very slowly.
Male hypogonadism
For long-term replacement in hypogonadism, 1 mL (equivalent to 250 mg testosterone enantate) is recommended every 2–3 weeks as a guide. Individual dosage can be modified depending on the clinical picture and serum testosterone levels measured.
In cases of rare, persistent and painful erection (priapism), the dose must be reduced or the therapy temporarily discontinued.
Puberty induction in boys with delayed puberty (pubertas tarda)
Puberty induction with testosterone enantate should be performed only by a physician experienced in paediatric endocrinology. The dosing schedule is predicated on the underlying pathological picture and should be guided by the relevant recommendations by professional associations. Various dosage regimens have been used. Some with lower dosages initially with gradual increases as puberty progresses, with or without a decrease to maintenance levels. Other regimens use higher dosage to induce pubertal changes and lower dosage for maintenance after puberty. The chronological and skeletal ages must be taken into consideration, both in determining the initial dose and in adjusting the dose. Dosage is within the range of 50 to 200 mg every 2 to 4 weeks within 4 to 6 months.
See prescribing information for full details.

– Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical.
– Puberty induction 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, Testosterone 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 this medical product in patients over 65 years of 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.
Testosterone 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.
This medical product 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. 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 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. This medical product 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.
* This medical product 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.
* This medical product 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.
Drug abuse and dependence
Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone
Administration: Like all oily solutions, this medical product must be injected precisely and very slowly via the intramuscular route. A pulmonary microembolism with oily solutions can in rare cases lead to signs and 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. The patient should therefore be observed during and immediately after each injection in order to allow for early recognition of possible signs and symptoms of pulmonary oily microembolism. Treatment is usually carried out with supportive measures, e.g. with supplemental oxygen administration.

Common: Haematocrit increased, red blood cell count increased, haemoglobin increased.
See prescribing information for full details.

Medicinal products that influence the effect of testosterone
Barbiturates and other enzyme inducers
Interactions may occur with medicinal products that induce microsomal enzymes. This may also result in increased testosterone clearance.
The effect of androgens on other medicinal products
Oxyphenbutazone
There have been reports of increased serum oxyphenbutazone levels.
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.
Antidiabetics: Androgens can increase insulin sensitivity and thereby reduce the doses of insulin or other antidiabetics needed for treatment.
Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Testoviron Depot-250 treatment. Concomitant use of testosterone replacement therapy and sodium-glucose co-transporter 2 (SGLT-2) inhibitors has been associated with an increased risk of erythrocytosis. Since both substances may independently elevate haematocrit levels, a cumulative effect is possible. Monitoring of haematocrit and haemoglobin levels is recommended in patients receiving both treatments.
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: This medical product 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.