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Helping Your Patients Restore Hormonal Balance with Confidence

Prescribing information and Adverse Event Reporting information can be found here 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   Tostran Special Warnings (Consult the Summary of Product Characteristics for more information). 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. Tostran Special Warnings (Consult the Summary of Product Characteristics for more information) 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.

Prescribing information and Adverse Event Reporting information can be found hereHealthcare Professionals (SmPC) Tostran offers flexible dosing Tostran offers flexible titration in 10mg increments, up to 80mg (maximum dose), enabling individualised, dosing for patients. Fig 1. Based on Tostran Summary of Product Characteristics One gram of gel contains 20 mg testosterone. One press of the canister piston delivers 0.5 g of gel containing 10 mg testosterone. The recommended starting dose of Tostran is 3 g gel (60 mg of testosterone). Dose titration should be based on both serum testosterone levels and the existence of clinical signs and symptoms related to androgen deficiency. The daily dose should not exceed 4 g of gel (80 mg testosterone). Priming the Tostran canister Each full depression of the canister piston delivers 0.5 g gel containing 10 mg testosterone. To obtain a full first dose, prime the canister pump. With the canister in the upright position, slowly and fully depress the actuator repeatedly until gel appears (fig. 1). Depress the actuator a further six times (fig 2) Discard the gel from the six depressions. Discard the gel from the six depressions. It is only necessary to prime the pump before the first dose. The canister should be stored in an upright position between use. Tostran Application The recommended starting dose of Tostran is 60mg (3g gel) Apply once daily at approximately the same time each morning. Apply to clean, dry, intact skin and rub in gently with one finger until dry. Rub the entire dose onto either the abdomen or both inner thighs, alternating daily. The abdomen site and both inner thigh areas should be an area of at least 10 x 15 cm each. Daily rotation between the abdomen and both inner thighs is recommended to minimise application site reactions. Wash hands with soap and water. Once the gel has dried, cover the application site with clean clothing. 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. Tostran Treatment Control Measure serum testosterone concentration approximately 14 days after initiation of therapy and at regular intervals to ensure proper dosing. The blood sample should be obtained 2 hours after application of Tostran. If the serum testosterone concentration is between 5.0 - 15.0 µ g/l, the dose should not be changed from 3g/day (60 mg testosterone). If the serum testosterone concentration is below 5.0 µ g/l, the dose should be increased to 4 g/day (80 mg testosterone). If the testosterone concentration is above 15.0 µ g/l, the dose should be reduced to 2 g/day (40 mg testosterone). Smaller 0.5 g gel (10 mg testosterone) dosage adjustments may be made if necessary. All testosterone measurements should be performed in the same laboratory.

Prescribing information and Adverse Event Reporting information can be found here Benefits of testosterone therapy in testosterone deficient men Testosterone preparations differ in formulation, routes of administration, dosage intervals and safety profiles.Optimised testosterone treatment can: Improve mood and well-being Improve muscle mass and strength Restore or maintain masculine characteristics, such as facial and body hair Maintain bone strength and prevent osteoporosis Maintain red cell production and prevent anaemia Induce or complete secondary sexual development Improve sex drive, libido and sexual function Jayasena CN, Anderson RA, Llahana S, et al. Society for Endocrinology guidelines for testosterone replacement therapy in male hypogonadism. Clin Endocrinol (Oxf). 2022;96:200?219. doi:10.1111/cen.146332

Prescribing information and Adverse Event Reporting information can be found here Managing Testosterone Deficiency Tostran® (testosterone) is indicated for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests1. Tostran is indicated for Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.1 Tostran is the only transdermal testosterone gel in UK that gives titration flexibility of 10mg incremental doses ranging from 10mg to 80mg per day. 1,2 Tostran improved signs & symptoms of testosterone deficiency syndrome & metabolic syndrome in hypogonadal men.4 1. Tostran Summary of Product Characteristics 2. Testogel Summary of Product Characteristics 3. Testavan Summary of Product Characteristics 4. Jones TH et al. Diabetes Care 2011; 34(4): 828-837