TESTOSTERONE UNDECANOATE (ANDRIOL, NEBIDO) — 250 MG/ML, 10 ML
Testosterone Undecanoate is a long-acting ester of testosterone formulated as an oil-based sterile solution for intramuscular administration. According to the supplied product information, testosterone undecanoate provides a prolonged testosterone depot following injection and has a reported mean half-life of approximately 33.9 ± 4.9 days. The supplied information also describes sustained testosterone concentrations following administration in hypogonadal men.
Testosterone is an endogenous androgen that plays an important role in the development and maintenance of male reproductive function and secondary sexual characteristics. Testosterone deficiency may be associated with reduced sexual desire, fatigue, reduced energy, changes in muscle mass, and reduced bone health. Testosterone replacement therapy may therefore be considered in appropriate adult male patients when testosterone deficiency has been clinically established.
The supplied information identifies Testosterone Undecanoate for replacement therapy in adult males with conditions associated with an absence or deficiency of endogenous testosterone production. These include primary hypogonadism, where testicular function is impaired, and hypogonadotropic hypogonadism, where insufficient gonadotropin or luteinising hormone-releasing hormone activity contributes to low testosterone concentrations.
Primary hypogonadism may result from congenital or acquired conditions affecting the testes. The supplied information includes conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter’s syndrome, chemotherapy, and certain toxic injuries. Hypogonadotropic hypogonadism may be associated with gonadotropin or LHRH deficiency or injury affecting the pituitary-hypothalamic system.
Testosterone undecanoate is formulated as an ester of testosterone. Esterification increases the lipid solubility of testosterone and allows the active hormone to be released gradually following intramuscular administration. This pharmacological characteristic distinguishes long-acting testosterone preparations from shorter-acting testosterone formulations.
Treatment with testosterone requires appropriate medical assessment and monitoring. Before treatment, the patient’s medical history and relevant risk factors should be reviewed. Particular attention should be given to prostate health, cardiovascular history, liver and kidney function, lipid status, sleep-related breathing disorders, blood-clotting history, and other conditions that may affect the suitability of androgen therapy.
The supplied product information identifies breast or prostate carcinoma as contraindications. It also highlights potential adverse effects including acne, injection-site pain, increased prostate-specific antigen (PSA), changes in estradiol levels, and other androgen-related effects. Rare adverse events associated with injectable testosterone undecanoate preparations may include pulmonary oil microembolism and anaphylaxis.
Testosterone therapy can also interact with other medicines. The supplied information identifies possible interactions with insulin and other antidiabetic medicines, oral anticoagulants such as warfarin, and corticosteroids. Medical supervision is therefore important when testosterone therapy is initiated, discontinued, or adjusted.
The supplied information provides a physician-directed dosing regimen for testosterone undecanoate. Because testosterone is a prescription androgen and inappropriate use can cause serious adverse effects, administration should follow the prescribing information and the instructions of a qualified healthcare professional. The product should not be used to increase dosage, frequency, or treatment duration without medical direction.
Testosterone Undecanoate 250 mg/ml is supplied as a 10 ml multiple-dose vial. The supplied storage instructions state that it should be stored in a cool, dry place at 15–25°C and protected from light.
3. Product Specifications
Specification Details
Product Name Testosterone Undecanoate
Brand References Andriol, Nebido
Strength 250 mg/ml
Active Ingredient Testosterone undecanoate
Molecular Formula C30H48O3
Molecular Weight 456.7003 g/mol
CAS Number 5949-44-0
Dosage Form Injectable, oil-based sterile solution
Route Intramuscular injection
Market Status Prescription
Company Hilma Biocare
Presentation 10 ml multiple-dose vial
4. Indications
The supplied information describes Testosterone Undecanoate as replacement therapy for adult males with conditions associated with deficient or absent endogenous testosterone production.
Primary hypogonadism may include:
Cryptorchidism
Bilateral torsion
Orchitis
Vanishing testis syndrome
Orchidectomy
Klinefelter’s syndrome
Certain chemotherapy-related or toxic testicular injuries
Hypogonadotropic hypogonadism may include:
Gonadotropin deficiency
LHRH deficiency
Pituitary-hypothalamic injury associated with tumours, trauma, or radiation
5. Contraindications
According to the supplied information, Testosterone Undecanoate should not be used in men with:
Known or suspected carcinoma of the prostate
Known or suspected carcinoma of the breast
Hypersensitivity to the product or its ingredients
A qualified healthcare professional should assess suitability before treatment.
6. Possible Side Effects
Reported adverse reactions in the supplied information include:
Acne
Injection-site pain
Increased PSA
Changes in estradiol
Hypogonadal symptoms
Premature closure of bony epiphyses in susceptible patients
Precocious puberty
Rare pulmonary oil microembolism
Rare anaphylaxis
7. Drug Interactions
Potential interactions listed in the supplied information include:
Insulin and antidiabetic medicines: testosterone may alter glucose control.
Oral anticoagulants: androgen therapy may affect anticoagulant activity and require closer monitoring.
Corticosteroids: concurrent use may increase fluid retention.
8. Patient Monitoring
Medical monitoring may include assessment of:
Testosterone levels
Prostate health and PSA
Haematological parameters
Lipid profile
Liver function
Cardiovascular risk factors
Blood glucose in patients with diabetes
Other parameters considered appropriate by the treating clinician
9. Dosage & Administration
The supplied source provides a physician-directed intramuscular dosing schedule for testosterone undecanoate. This is a prescription medicine and should only be administered according to a qualified healthcare professional’s prescription and the applicable product information.
Do not increase the dose, injection frequency, or duration of treatment without medical supervision.
10. Presentation
Testosterone Undecanoate 250 mg/ml — 10 ml multiple-dose vial.
11. Storage
Store in a cool, dry place between 15–25°C.
Protect from light.
