Nebido 1000 mg/4 ml Solution for Injection
Nebido
Prescription MedicinesTestosterone Replacement Therapy
Certifications
- Authorised as a prescription Only medicine by relevant national medicines regulatory authorities (e.g. MHRA in the UK, HPRA and other EU authorities).
- Manufactured in accordance with Good Manufacturing Practice (GMP) standards for medicinal products.
- Subject to ongoing pharmacovigilance, including reporting of suspected adverse reactions through national systems such as the MHRA Yellow Card scheme.
- Authorised as a prescription Only medicine by relevant national medicines regulatory authorities (e.g. MHRA in the UK, HPRA and other EU authorities).
- Manufactured in accordance with Good Manufacturing Practice (GMP) standards for medicinal products.
- Subject to ongoing pharmacovigilance, including reporting of suspected adverse reactions through national systems such as the MHRA Yellow Card scheme.
Testosterone Replacement Therapy
Description
Nebido 1000 mg/4 ml Solution for Injection is a long-acting depot preparation of testosterone undecanoate for intramuscular use in adult men with confirmed hypogonadism. Each 4 ml ampoule or vial contains 1000 mg testosterone undecanoate (250 mg/ml) dissolved in castor oil with benzyl benzoate as excipient, forming a clear, colourless to yellowish-brown oily solution. After deep intramuscular injection into the gluteal muscle, testosterone undecanoate is slowly released and cleaved to testosterone, providing sustained serum testosterone levels and allowing dosing intervals of typically 10 to 14 weeks. Nebido is used as testosterone replacement therapy to treat clinical symptoms and biochemical deficiency in male hypogonadism, such as reduced libido, erectile dysfunction, infertility, fatigue, loss of muscle mass, decreased bone density and mood disturbances.
Bnefits
- Long-acting depot testosterone injection providing stable testosterone levels with dosing intervals usually every 10 to 14 weeks.
- Avoids daily or frequent dosing associated with shorter-acting testosterone formulations, improving convenience and adherence.
- By restoring physiologic testosterone levels, it helps improve libido, erectile function and overall sexual health in hypogonadal men.
- Supports increases in lean body mass and muscle strength and helps reduce fat mass when combined with appropriate lifestyle measures.
- Helps maintain or improve bone mineral density, reducing the risk of osteoporosis related to androgen deficiency.
- Intramuscular depot administration bypasses first-pass hepatic metabolism associated with some oral androgen preparations.
- Dosing can be individualised by adjusting injection intervals based on trough testosterone levels and clinical response.
- Established safety and efficacy profile with extensive clinical use and regulatory approval in multiple countries.
Indications
- Testosterone replacement therapy in adult men with primary or secondary hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
- Treatment of symptoms associated with male hypogonadism such as reduced libido, erectile dysfunction, impaired fertility, fatigue, depressed mood, loss of muscle mass and decreased bone mineral density, when due to testosterone deficiency.
Composition
- Active ingredient: 1000 mg testosterone undecanoate in 4 ml solution (250 mg testosterone undecanoate per ml), corresponding to approximately 631.5 mg testosterone per ampoule or vial.
- Excipient with known effect: 2000 mg benzyl benzoate per 4 ml ampoule or vial.
- Other excipients: refined castor oil (vehicle for the oily solution).
- Sugar free and contains no preservatives.
Formulation
- Pharmaceutical form: clear, colourless to yellowish-brown oily solution for injection.
- Depot intramuscular formulation of testosterone undecanoate in castor oil with benzyl benzoate, designed for slow release from the injection site.
- Concentration: 250 mg/ml testosterone undecanoate in a 4 ml ampoule or vial (total 1000 mg per container).
- Sterile, pyrogen-free, single-use solution intended strictly for deep intramuscular injection.
Packaging
- Single-use 4 ml type I glass ampoule or vial containing 1000 mg testosterone undecanoate in oily solution.
- Each pack from the referenced seller contains 1 x Nebido 1000 mg/4 ml solution for injection.
- Supplied in an outer carton with package leaflet and labelling compliant with prescription medicine regulations.
Usage
- Nebido is for intramuscular use only and must be administered by a healthcare professional experienced in testosterone therapy.
- Inject one 4 ml ampoule or vial (1000 mg testosterone undecanoate) very slowly (over approximately 2 minutes) deep into the gluteal muscle, taking special care to avoid intravascular injection.
- Before starting treatment, confirm hypogonadism with clinical assessment and at least two separate serum testosterone measurements taken in the morning.
- At the start of therapy, serum testosterone levels should be measured before and during initiation; the first injection interval may be shortened to a minimum of 6 weeks to reach steady-state levels more rapidly if clinically indicated.
- For maintenance, the recommended injection interval is generally every 10 to 14 weeks; adjust interval based on trough testosterone levels at the end of an injection cycle and the patient’s clinical symptoms.
- Do not divide the contents of a single ampoule or vial between multiple patients; the full 4 ml dose is intended for one patient and should be used immediately after opening.
- Regularly monitor serum testosterone, haematocrit/haemoglobin, lipid profile, liver function, PSA and prostate status, as well as clinical response and adverse effects during long-term therapy.
- Use caution in patients with pre-existing cardiovascular, hepatic, renal or prostatic disease and follow specific monitoring recommendations in the official product information.
- If signs of serious adverse reactions such as pulmonary oil microembolism (e.g. cough, dyspnoea, chest pain) or anaphylactic reactions occur during or immediately after injection, stop the injection and provide appropriate medical management.
- Nebido is not indicated for use in women or children and adolescents under 18 years of age.
Contraindications
- Known or suspected androgen-dependent carcinoma of the prostate or male breast carcinoma.
- Past or present liver tumours.
- Hypercalcaemia associated with malignant tumours.
- Hypersensitivity to testosterone undecanoate or to any of the excipients (benzyl benzoate, castor oil).
- Use in women is contraindicated.
- Use in children and adolescents under 18 years is not indicated.
- Nebido should not be used in men with severe cardiac, hepatic or renal insufficiency without careful specialist assessment due to potential fluid retention and related complications.
Adverse Effects
- Very common and common adverse reactions include acne, injection-site pain or discomfort, increased haematocrit or erythrocytosis, weight gain and oily skin.
- Changes in prostate parameters such as increased prostate-specific antigen (PSA) and possible exacerbation of benign prostatic hyperplasia symptoms.
- Fluid retention and oedema, which may be of concern in patients with underlying cardiac, hepatic or renal disease.
- Mood and libido changes, including increased or decreased libido, irritability or mood swings.
- Gynaecomastia, testicular atrophy, changes in sperm production and possible effects on fertility with long-term use.
- Headache, dizziness, hair loss or increased body hair growth and voice changes may occur in some patients.
- Laboratory changes including alterations in lipid profile, liver enzymes and coagulation parameters.
- Pulmonary oil microembolism (POME) events and anaphylactic reactions have been reported rarely in association with testosterone undecanoate depot injections; symptoms may include cough, dyspnoea, chest pain, malaise, sweating, dizziness or syncope during or immediately after injection and require prompt medical attention.
- As with all intramuscular injections, there is a risk of local reactions such as bruising, haematoma, induration or infection at the injection site.
Storage Conditions
- Store in the original package to protect from light.
- Store at or below the temperature specified in the official product information (commonly not above 30 °C).
- Do not freeze.
- Keep out of the sight and reach of children.
- Do not use after the expiry date printed on the pack.
- Do not use if the ampoule or vial is cracked, damaged, or the solution shows visible particulate matter or significant discoloration.
Duration
Nebido is generally intended for long-term testosterone replacement therapy. Duration of treatment is individual and may be lifelong in chronic hypogonadism, with injection intervals typically every 10 to 14 weeks; continuation should be regularly re-evaluated based on clinical response, laboratory monitoring and risk\u2013benefit assessment.
Onset
Serum testosterone concentrations begin to rise within days after intramuscular injection, with peak levels usually reached within one to two weeks and maintained within the therapeutic range throughout the dosing interval. Clinical improvements in symptoms such as libido, mood, energy and erectile function often become evident within several weeks, while changes in body composition and bone density may take several months of continuous therapy.
