Page 43 - P4304.1-V102_PS Magazine - Oct 24 (PRINT)

Testosterone

Undecanoate

Testosterone undecanoate EVER Pharma 1000mg/4ml solution for injection, is
a testosterone replacement therapy for male hypogonadism, when testosterone
deficiency has been confirmed by clinical features and biochemical tests.

Pregnancy - Testosterone undecanoate EVER Pharma solution for injection
is not indicated for use in women and must not be used in pregnant or
breast-feeding women.
Now included in the Kent Pharma MDS Scheme... PL 46654/0014

Pack Kent NHS PSUK
Product Name Strength Shelf Life PIP Code EAN Code Net Price
Size List Price Discount
Testosterone Undecanoate
EVER Pharma 1000mg/ 1 x 4ml 2 Years 127-6328 9010453004068 £74.04 15% £62.93
4ml
1000mg/4ml solution for injection
Prescribing information
(Please refer to the Summary of Product Characteristics before prescribing). signs of intra-abdominal haemorrhage occur in men using Testosterone undecanoate EVER Pharma solution for
Name and active ingredients: Testosterone undecanoate EVER Pharma 1000mg/4ml solution for injection. injection, a liver tumour should be included in the differential-diagnostic considerations. Hepatic or renal
Therapeutic indications: Testosterone replacement therapy for male hypogonadism, when testosterone deficiency insufficiency – Testosterone replacement therapy should be used with caution in these patients. Cardiac
has been confirmed by clinical features and biochemical tests (see SmPC section 4.4). Posology: One vial insufficiency - Caution should be exercised in patients predisposed to oedema, e.g. in case of severe cardiac, hepatic,
(corresponding to 1000mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this or renal insufficiency or ischemic heart disease, as treatment with androgens may result in increased retention of
frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation. Start of sodium and water. In case of severe complications characterized by oedema with or without congestive heart
treatment – Serum testosterone levels should be measured before and during initiation of treatment. Depending failure treatment must be stopped immediately (see SmPC section 4.8). Testosterone may cause a rise in blood
on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 pressure and should be used with caution in men with hypertension. Clotting disorders – The limitations of using
weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, intramuscular injections in patients with acquired or inherited bleeding disorders always have to be observed.
sufficient steady state testosterone levels may be achieved more rapidly. Maintenance and individualisation of Testosterone should be used with caution in patients with thrombophilia or risk factors for venous
treatment – Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is thromboembolism (VTE). In thrombophilic patients, VTE cases have been reported even under anticoagulation
advisable to measure testosterone serum levels regularly at the end of an injection interval and with clinical treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated.
symptoms considered. These serum levels should be within the lower third of the normal range. Special populations Other conditions – Testosterone undecanoate EVER Pharma solution for injection should be used with caution in
- Patients with hepatic impairment - The use of Testosterone undecanoate EVER Pharma solution for injection is patients with epilepsy and migraine, as the conditions may be aggravated. Improved insulin sensitivity may occur in
contraindicated in men with past or present liver tumours (see SmPC section 4.3). Method of administration: patients treated with androgens who achieve normal testosterone plasma concentrations following replacement
Strictly for intramuscular injection and must be administered very slowly (over two minutes). Care should be taken therapy. Therefore, the dosage of hypoglycaemic agents may need to be lowered. Pre-existing sleep apnoea may be
to inject the solution deeply into the gluteal muscle following the usual precautions for intramuscular administration. potentiated. Androgens are not suitable for enhancing muscular development in healthy individuals or for
Special care must be taken to avoid intravasal injection (see SmPC section 4.4 under Application). The contents of a increasing physical ability. Drug abuse and dependence – Testosterone has been subject to abuse, typically at doses
vial are to be injected intramuscularly immediately after opening. Contraindications: The use of Testosterone higher than recommended for the approved indication(s) and in combination with other anabolic androgenic
undecanoate EVER Pharma solution for injection is contraindicated in men with androgen-dependent carcinoma of steroids which carries serious health risks and is to be discouraged. Application – Pulmonary micro embolism of oily
the prostate or of the male mammary gland, past or present liver tumours and hypersensitivity to the active solutions like Testosterone undecanoate EVER Pharma solution, can in rare cases lead to signs and symptoms such
substance or to any of the excipients (listed in SmPC section 6.1) The use of Testosterone undecanoate EVER as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may
Pharma solution for injection in women is contraindicated. Special warnings and precautions for use: Testosterone occur during or immediately after the injection and are reversible. Interaction with other medicinal products and
undecanoate EVER Pharma solution for injection is not recommended for use in children and adolescents. other forms of interaction: Oral anti-coagulants – Testosterone and derivatives have been reported to increase the
Testosterone undecanoate EVER Pharma solution for injection should be used only if hypogonadism (hyper- and activity of coumarin derived oral anti-coagulants. Other interactions – Concurrent administration of testosterone
hypogonadotrophic) has been demonstrated and if other aetiology, responsible for the symptoms, has been with ACTH or corticosteroids may enhance oedema formation. Fertility, pregnancy and lactation: Fertility –
excluded before treatment is started. Testosterone insufficiency should be clearly demonstrated by clinical features Testosterone replacement therapy may reversibly reduce spermatogenesis (see SmPC sections 4.8 and 5.3).
(regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile Pregnancy and breastfeeding – Testosterone undecanoate EVER Pharma solution for injection is not indicated for
dysfunction etc.) and confirmed by two separate blood testosterone measurements. Elderly population - There is use in women and must not be used in pregnant or breast-feeding women (see SmPC section 4.3). Undesirable
limited experience on the safety and efficacy of the use of Testosterone undecanoate EVER Pharma solution for effects: Common (≥1/100 to <1/10) – Polycythaemia, Haematocrit increased, Red blood cell count increased,
injection in patients over 65 years of age. Medical examination – Prior to testosterone initiation, all patients must Haemoglobin increased, Weight increased, Hot flush, Acne, Prostate specific antigen increased, Prostate
undergo a detailed examination to exclude a risk of pre-existing prostatic cancer. Careful and regular monitoring of examination abnormal, Benign prostate hyperplasia, Various kinds of injection site reactions. Uncommon (≥1/1000
the prostate gland and breast must be performed in accordance with recommended methods (digital rectal to < 1/100) – Hypersensitivity, Increased appetite, Glycosylated haemoglobin increased, Hypercholesterolaemia,
examination and estimation of serum PSA) in patients receiving testosterone therapy at least once yearly and twice Blood triglycerides increased, Blood cholesterol increased, Depression, Emotional disorder, Insomnia, Restlessness,
yearly in elderly patients and at risk patients (those with clinical or familial factors). Local guidelines for safety Aggression, Irritability, Headache, Migraine, Tremor, Cardiovascular disorder, Hypertension, Dizziness, Bronchitis,
monitoring under testosterone replacement therapy should be taken into consideration. Laboratory tests – Sinusitis, Cough, Dyspnoea, Snoring, Dysphonia, Diarrhoea, Nausea, Liver function test abnormal, Aspartate
Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should aminotransferase increased, Alopecia Erythema, Rash, Pruritus, Dry skin, Arthralgia, Pain in extremity, Muscle
adjust the dosage individually to ensure maintenance of eugonadal testosterone levels. In patients receiving long- disorders 2 , Musculoskeletal stiffness, Blood creatine phosphokinase increased, Urine flow decreased, Urinary
term androgen therapy, laboratory parameters including haemoglobin and haematocrit, liver function tests and retention, Urinary tract disorder, Nocturia, Dysuria, Prostatic dysplasia, Prostate induration, Prostatitis, Prostatic
lipid profile should be regularly monitored (see SmPC section 4.8). Due to variability in laboratory values, all disorder, Libido changes, Testicular pain, Breast induration, Breast pain, Gynaecomastia, Oestradiol increased,
measures of testosterone should be carried out in the same laboratory. Tumours – Androgens may accelerate the Testosterone increased, Fatigue, Asthenia, Hyperhidrosis. Rare (≥1/10,000 to <1/1,000) – Pulmonary oil micro
progression of sub-clinical prostatic cancer and benign prostatic hyperplasia. Testosterone undecanoate EVER embolism. Presentation: 5ml amber glass (type I) vial with a bromobutyl rubber stopper and an aluminium cap
Pharma solution for injection should be used with caution in cancer patients at risk of hypercalcaemia (and containing a fill volume of 4ml. Pack size: 1 x 4ml. List Price: £74.04. Legal Classification: POM. Marketing
associated hypercalciuria), due to bone metastases. Regular monitoring of serum calcium concentrations is Authorisation Holder: EVER Valinject GmbH, Oberburgau 3, 4866 Unterach am Attersee, Austria. Marketing
recommended in these patients. Cases of benign and malignant liver tumours have been reported in users of Authorisation Number: PL 46654/0014. For a copy of the SmPC or further medical information, please contact:
hormonal substances such as androgen compounds. If severe upper abdominal complaints, liver enlargement or medical@kent-athlone.com. Date of preparation: May 2024 UK24/006 SmPC May 2024.
Adverse events should be reported.Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Kent
Pharma UK Ltd on 01233 506574 or medical@kentathlone.com. For a copy of the SmPC or further medical information, please contact: medical@kentathlone.com. Additional information available on request. Date of preparation: July 2024 Ref: UK24/17/01
For further information and to sign up to the Kent Pharma MDS Scheme, contact your PSUK Account Manager today!
Kent Pharma UK Ltd | 2nd Floor | Connect 38 | 1 Dover Place | Ashford | Kent | TN23 1FB
Tel: +44 (0) 845 437 5565 | Email: customer.service@kent-athlone.com
www.kentpharma.co.uk
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