Testosterone esters injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection of testosterone esters.
Drugs List
Therapeutic Indications
Uses
Supportive therapy for female-to-male transsexuals
Testosterone replacement therapy associated with hypogonadism in males
Dosage
Adjust dose according to individual response.
Adults
Testosterone replacement therapy in primary and secondary hypogonadal disorders
250mg testosterone esters injected once every 3 weeks is often considered adequate.
Female-to-male transsexuals
Dosage recommendations vary from one 250mg injection given every two weeks, to one 250mg injection every four weeks.
Administration
For deep intramuscular injection.
Contraindications
Children under 3 years
Suspected prostate cancer
Androgen-dependent neoplasm
Breast cancer
Breastfeeding
History of hepatic neoplasm
Hypercalcaemia
Pregnancy
Prostate cancer
Precautions and Warnings
Children aged 3 to 18 years
Family history of breast cancer
Pre-pubertal children
Predisposition to hypercalcaemia
Predisposition to venous thromboembolism
Bronchial carcinoma
Cardiac impairment
Diabetes mellitus
Epileptic disorder
Hepatic impairment
History of endometrial cancer
Hypertension
Ischaemic heart disease
Migraine
Psychiatric disorder
Renal cell carcinoma
Renal impairment
Skeletal metastasis
Sleep apnoea
Thrombophilia
Contains arachis (peanut) oil
Contains benzyl alcohol
Monitor testosterone levels at baseline and periodically during treatment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor calcium levels in patients at risk of hypercalcaemia
Monitor female to male transsexuals for hormone dependent neoplasms
Monitor hepatic function, haematocrit and haemoglobin in long term therapy
Monitor serum lipids profile regularly in long term therapy
Patients at risk of osteoporosis should have bone density assessed
Regular examination of prostate advised to exclude prostatic cancer
Abuse may cause serious adverse events, dependence and withdrawal symptoms
Increased risk of premature sexual development+epiphyseal closure in boys
Reinitiate therapy at lower dose once androgen dependent effects resolve
May interfere with thyroid function tests
Discontinue if oedema progresses or signs of cardiac failure occur
Cases of venous thromboembolism have been reported even under anticoagulant treatment, testosterone treatment requires careful evaluation after the first thrombotic event.
Female-to-male transsexual supportive therapy
Hysterectomy and bilateral oophorectomy should be considered 18 to 24 months after treatment of testosterone, to reduce risk of endometrial and ovarian cancer. Continued monitoring is required for patients on long term treatment who did not proceed with such interventions.
Pregnancy and Lactation
Pregnancy
Testosterone esters are contraindicated during pregnancy.
The manufacturer advises treatment with testosterone esters should be discontinued during pregnancy. Human data have shown teratogenic effects. Testosterone rapidly crosses the placenta and causes masculinisation of the female foetus.
Lactation
Testosterone esters are contraindicated during breastfeeding.
The manufacturer advises testosterone esters should not be used during breastfeeding. There is no clear data on whether testosterone, given by oily injection, appears in breast milk after maternal exposure during breast feeding.
Side Effects
Abnormal clotting factor
Acne
Aggression
Alopecia
Altered glucose tolerance
Altered serum lipid profile
Anxiety
Arthralgia
Asthenia
Changes in libido
Cholestatic jaundice
Decreased ejaculate volume
Depression
Electrolyte disturbances
Fluid retention
Frequent or persistent erections
Gynaecomastia
Headache
Hepatic impairment
Hepatic tumours
Hirsutism
Hoarseness
Hypercalcaemia
Hypercalciuria
Hypertension
Increase in haematocrit
Increase in haemoglobin
Increase in prostate specific antigen (PSA)
Increased bone growth
Injection site reactions
Irregular menstruation
Irritability
Male pattern baldness
Mood changes
Muscle cramps
Myalgia
Nausea
Nervousness
Oedema
Oligospermia
Paraesthesia
Peliosis hepatis
Phallic enlargement in prepubertal males
Polycythaemia
Precocious sexual development (pre-pubertal males)
Premature closure of epiphyses (in pre-pubertal males)
Priapism
Prostate abnormalities
Prostate cancer
Pruritus
Seborrhoea
Sleep apnoea
Sodium retention
Spermatogenesis suppression
Testicular atrophy
Virilism in females
Voice changes
Weight gain
Effects on Laboratory Tests
Athletes should be advised that testosterone replacement therapy contains an active substance which may produce a positive reaction in an anti-doping test.
May decrease thyroxine-binding globulin levels. Free thyroid levels and thyroid function remain unchanged.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: December 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Sustanon 250, 250mg/ml solution for injection. Aspen. Revised June 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 November 2019
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Testosterone Last revised: 3 December 2018
Last accessed: 14 November 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.