Testosterone undecanoate parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of testosterone undecanoate.
Drugs List
Therapeutic Indications
Uses
Hypogonadism - in male
Replacement therapy for male hypogonadism where testosterone deficiency has been confirmed by clinical features and biochemical tests.
Dosage
Adults
1000mg every 10 to 14 weeks.
Treatment initiation:
Measure serum testosterone levels before and during treatment. The first injection interval may be reduced to 6 weeks to achieve sufficient steady state testosterone levels more rapidly.
Maintenance :
After the initial loading doses, injection intervals should be kept within the 10 to 14 week range. Serum testosterone levels and clinical symptoms should determine the interval.
At the end of a dosing interval, the serum testosterone levels should be in the lower third of the normal range.
Higher serum levels at the end of the interval would indicate the need for a longer injection interval.
Lower serum levels indicate the need for a shorter injection interval.
Administration
For deep intramuscular slow injection (over two minutes) into the gluteal muscle only.
Contraindications
Children under 18 years
Androgen-dependent neoplasm
Breast cancer in males
Hepatic neoplasm
History of hepatic neoplasm
Hypercalcaemia
Prostate cancer
Precautions and Warnings
Patients over 65 years
Predisposition to hypercalcaemia
Predisposition to venous thromboembolism
Benign prostatic hyperplasia
Coagulopathy
Diabetes mellitus
Epileptic disorder
Hepatic impairment
Hypertension
Ischaemic heart disease
Migraine
Renal impairment
Severe cardiac disorder
Skeletal metastasis
Sleep apnoea
Thrombophilia
Exclude other causes of hypogonadism prior to treatment
Observe patient closely during and immediately after administration
For slow, deep intramuscular injection into the gluteal muscle
If intra-abdominal haemorrhage consider liver tumour
If upper abdominal complaints/liver enlargement consider liver tumour
Monitor blood glucose closely in patients with diabetes mellitus
Monitor calcium levels in patients at risk of hypercalcaemia
Monitor haematological parameters regularly throughout treatment
Monitor hepatic function regularly
Monitor patients with epilepsy while taking this treatment
Monitor patients with migraine during treatment
Monitor serum lipids profile regularly in long term therapy
Monitor testosterone levels periodically
Regular examination of breasts advised to exclude possibility of cancer
Regular examination of prostate advised to exclude prostatic cancer
Abuse may cause serious adverse events, dependence and withdrawal symptoms
May induce or enhance hepatic tumour development
May interfere with thyroid function tests
Measurements of plasma testosterone should be carried out in the same lab
Discontinue if oedema progresses or signs of cardiac failure occur
Discontinue if signs of excessive androgen exposure persists/re-occurs
If polycythaemia occurs, suspend treatment or reduce dose
May affect spermatogenesis
Testosterone deficiency should be clearly demonstrated by clinical features (e.g. regression of secondary sexual characteristics, change in body composition, asthenia, reduced libido, erectile dysfunction). Confirmation via two separate blood testosterone measurements is required.
Exclude pre-existing prostate cancer prior to initiation of treatment. Detailed and regular monitoring of the prostate (digital rectal examination and estimation of serum PSA) and breast should be performed. These tests should be performed twice annually in elderly patients and those at risk (clinical or familial factors); or annually in all other patients.
May accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia.
Improved insulin sensitivity may occur when normal testosterone plasma concentrations are achieved.
Pregnancy and Lactation
Pregnancy
Not indicated for use in women.
Lactation
Not indicated for use in women.
Counselling
Athletes should be advised that testosterone replcement therapy contains an active substance which may produce a positive reaction in an anti-doping test.
Side Effects
Abnormal liver function tests
Acne
Aggression
Alopecia
Anaphylactic reaction
Anxiety
Arthralgia
Aspartate aminotransferase increased
Asthenia
Breast changes
Breast pain
Bronchitis
Cardiac disorders
Changes in libido
Chest pain
Cough
Creatine phosphokinase increased
Depression
Diarrhoea
Dizziness
Dry skin
Dysphonia
Dyspnoea
Dysuria
Elevated blood testosterone
Emotional disorder
Erythema
Fatigue
Fluid retention
Frequent or persistent erections
Gynaecomastia
Headache
Hepatic tumours
Hostility
Hot flushes
Hypercholesterolaemia
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypertrichosis
Impaired urination
Increase in haematocrit
Increase in haemoglobin
Increase in plasma triglyceride concentration
Increase in prostate specific antigen (PSA)
Increased appetite
Increased glycated haemoglobin (HbA1c) levels
Injection site reactions
Insomnia
Interference with spermatogenesis
Irritability
Jaundice
Migraine
Mood changes
Muscle cramps
Muscle disorders
Myalgia
Nausea
Nervousness
Nocturia
Oedema
Oestradiol increased
Pain during erection
Pain on intramuscular injection
Painful extremities
Paraesthesia
Polycythaemia
Prostate abnormalities
Prostate cancer
Prostatic hyperplasia
Prostatitis
Pruritus
Pulmonary embolism
Pulmonary oil microembolism
Rash
Restlessness
Seborrhoea
Sinusitis
Skin disorder
Sleep apnoea
Snoring
Stiffness
Syncope
Testicular disorders
Testicular pain
Thrombosis
Tremor
Urinary retention
Urinary tract disorders
Weight gain
Effects on Laboratory Tests
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 ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Further Information
Last Full Review Date: November 2021
Reference Sources
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 November 2021
Summary of Product Characteristics: Nebido 1000mg/4ml, solution for injection. Bayer plc. Revised March 2020.
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