Tostran^® (Testosterone) Safety & Tolerability

Tostran Contraindications, Interactions & Adverse Events

Contraindications

• Hypersensitivity to active substance(s) or to any of the excipients.
• Known or suspected carcinoma of the breast or the prostate.

Interactions

• Patients receiving oral anticoagulants require close monitoring of their INR especially when androgen treatment is started, stopped or the dose of Tostran changed.

Frequency of Adverse Events

• There is limited experience of treating men older than 65 years with Tostran.
• No formal studies have been conducted in patients with renal or hepatic impairment.
• 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 such cases, treatment must be stopped immediately.
• Tostran should be used with caution in men with hypertension.
• In patients receiving long-term androgen therapy, haemoglobin, and haematocrit, liver function tests and lipid profile laboratory parameters should also be monitored.
• Tostran is not indicated for treatment of male sterility or sexual impotence.
• 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. Androgens may accelerate the progression of sub- clinical prostatic cancer and benign prostatic hyperplasia.
• The treatment of hypogonadal men with testosterone may potentiate sleep apnoea in some patients.
• Care should be taken in patients with skeletal metastases due to the risk of hypercalcaemia/hypercalciuria developing from androgen therapy. Regular monitoring of the serum levels of calcium in these patients is recommended.

• Use with caution in patients with epilepsy and migraine as these conditions may be aggravated.
• Improved insulin sensitivity may occur in patients treated with androgens who achieve normal testosterone plasma concentrations following replacement therapy.
• Athletes should be informed that Tostran contains an active substance (testosterone), which may give positive results in a doping test.
• Tostran should not be used in women due to possible virilising effects.
• Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism.
• Additional caution should be taken when using this product and in close physical contact with children as secondary transmission of testosterone through clothing cannot be excluded.
• Pregnant women must avoid contact with Tostran application sites.
• Tostran may cause burning sensation on damaged skin.
• Tostran is flammable until dry.