|Active substance||Testosterone Undecanoate|
|IN Brand||Cernos Depot|
|Manufacturing by||Sun Pharmaceutical|
|Form release||1 ampoule|
|Shipping time||7 – 18 days (Depending from the Country)|
|Availability & Order|
It is used in androgen replacement therapy primarily for the treatment of male hypogonadism, and has also been investigated for use as a male contraceptive or as hormone replacement therapy in transgender men. Unlike other testosterone esters, testosterone undecanoate is available in both oral and intramuscular formulations.
The Reandron 1000 formulation (Nebido in the United States, Cernos Depot in India) contains 1000 mg of testosterone undecanoate suspended in castor oil with benzyl benzoate for solubilisation and as a preservative, and is administered by intramuscular injection. As an excipient, benzyl benzoate has been reported as a cause of anaphylaxis in a case in Australia. Bayer includes this report in information for health professionals and recommends that physicians “should be aware of the potential for serious allergic reactions” to preparations of this type. In Australia, reports to ADRAC, which evaluates reports of adverse drug reactions for the Therapeutic Goods Administration, show several reports of allergic issues since the anaphylaxis case from 2011.
One ampoule / vial of Nebido (corresponding to 1000 mg testosterone undecanoate) is injected every 10 to 14 weeks. Injections with this frequency are capable of maintaining sufficient testosterone levels and do not lead to accumulation.
Start of treatment
Serum testosterone levels should be measured before start and during initiation of treatment. Depending on serum testosterone levels and clinical symptoms, the first injection interval may be reduced to a minimum of 6 weeks as compared to the recommended range of 10 to 14 weeks for maintenance. With this loading dose, sufficient steady state testosterone levels may be achieved more rapidly.
Maintenance and individualisation of treatment
The injection interval should be within the recommended range of 10 to 14 weeks. Careful monitoring of serum testosterone levels is required during maintenance of treatment. It is advisable to measure testosterone serum levels regularly. Measurements should be performed at the end of an injection interval and clinical symptoms considered. These serum levels should be within the lower third of the normal range. Serum levels below normal range would indicate the need for a shorter injection interval. In case of high serum levels an extension of the injection interval may be considered.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Reaction at the injection site.
- Prostate problems, such as growth of the prostate gland, increased PSA levels and prostate cancer (see warning section above).
- Feeling sick and vomiting.
- Mood changes.
- Nervousness, anxiety or irritability.
- Change in sex drive.
- Breast pain, enlargement of the breasts.
- Persistent painful erection of the penis (priapism). Tell your doctor straight away if you experience this.
- Decreased sperm count.
- Swelling caused by fluid retention (oedema).
- Increased blood pressure (hypertension).
- Increased levels of red blood cells and haemoglobin in the blood (polycythaemia).
- Weight gain.
- Pain in the muscle or joints.
- Male-pattern hair loss.
- Raised cholesterol levels.
- Liver tumours.
- Premature sexual development if used in boys who haven’t reached puberty.
- Premature closure of the ends of bones, causing stunted growth if used in boys who haven’t reached puberty.
The side effects listed above may not include all of the side effects reported by the medicine’s manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.