Testoviron Depot Special Precautions

The general aim of androgen replacement therapy for confirmed testosterone deficiency in males is to keep serum testosterone levels within the reference range for the age group concerned. Overreplacement should be avoided.
Androgens are not indicated for enhancing muscular development in healthy individuals or for increasing physical ability.
Older patients treated with androgens may be at increased risk for the development of prostatic hyperplasia. Androgens can enhance the growth of an existing prostatic carcinoma. Therefore, carcinoma of the prostate has to be excluded before starting therapy with testosterone preparations.
As a precaution, regular examinations of the prostate are recommended. Haemoglobin and haematocrit should be checked periodically in patients on long-term androgen therapy to detect cases of polycythaemia (see Adverse Reactions).
Testosterone replacement therapy should only be given to men when deficiency of the hormone has been confirmed by clinical features and biochemical tests. Testosterone levels should then be monitored regularly during treatment. Haemoglobin, haematocrit, liver function and blood lipid profile should also be monitored regularly.
In general, the risk of bleeding from using intramuscular injections in patients with acquired or inherited bleeding disorders always has to be taken into account. Testosterone and its derivatives have been reported to increase the activity of coumarin-derived oral anticoagulants (see also Interactions).
Testosterone should be used with caution in patients with thrombophilia, as there have been post-marketing studies and reports of thrombotic events in these patients during testosterone therapy.
Cases of benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage, have been observed after the use of hormonal substances such as the one contained in Testoviron Depot. The doctor must therefore be informed of the occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time as it may then be necessary to withdraw the preparation. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in men using Testoviron Depot.
Caution should be exercised in patients predisposed to oedema. e.g. in case of severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, as treatment with androgens may result in increased retention of sodium and water. In case of severe complications characterised by oedema with or without congestive heart failure, treatment must be stopped immediately (see Adverse Reactions).
Testosterone may cause a rise in blood pressure and Testoviron Depot should be used with caution in men with hypertension.
Testoviron Depot must not be used in women, due to possible virilising effects.
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.
Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use.
Abuse of testosterone along with other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/ or psychiatric events.
Pre-existing sleep apnoea may be potentiated.
As with all oily solutions, Testoviron Depot must be injected intramuscularly and extremely slowly. Pulmonary microembolism of oily solutions can lead to signs and symptoms such as cough, dyspnoea and chest pain. There may be other signs and symptoms including vasovagal reactions such as malaise, hyperhydrosis, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible.
Treatment is usually supportive, e.g. by administration of oxygen.
Clotting disorders: 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 to minimise the individual VTE risk. 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.
Use in Hepatic Impairment: No formal studies have been performed in patients with liver impairment. The use of Testoviron Depot is contraindicated in men with past or present liver tumours.
Use in Renal Impairment: See previously mentioned.
Effects on Laboratory Tests: See Interactions.
Effects on Ability to Drive and Use Machines: Not known.
Use in Children: Testoviron Depot is not indicated for use in children and adolescents.
In addition to causing masculisation in children, testosterone can cause accelerated growth, bone maturation and premature epiphyseal closure, thereby reducing adult height.
Use in the Elderly: Limited data do not suggest the need for a dosage adjustment in elderly patients.
There is limited experience on the safety and efficacy of the use of these medicines in patients over 65 years of age. It should be borne in mind that physiological testosterone levels naturally decrease somewhat with age.