Nebido is a drug used in testosterone replacement therapy.
Release form and composition
Nebido is produced in the form of a solution for intramuscular injection: clear, oily, with a yellowish tinge (in ampoules of type I amber glass, 4 ml each, and 1 ampoule in a cardboard box with a glued-in holder).
The composition of 1 ampoule includes:
- Active substance: testosterone undecanoate - 1 g;
- Auxiliary components: benzyl benzoate - 2 g; refined castor oil (for parenteral administration) - 1.18 g.
Indications for use
Nebido is prescribed to men with testosterone deficiency in primary and secondary hypogonadism (testosterone replacement therapy).
- Androgen-dependent carcinoma of the mammary and prostate glands;
- Liver tumors (in history or at present);
- Hypercalcemia associated with malignant tumors;
- Hypersensitivity to the drug.
Nebido should be used with caution in apnea syndrome.
Due to limited data, the drug is not prescribed to men under 18 years of age. Studies on the safety and efficacy of therapy in patients with functional disorders of the liver and renal failure have not been conducted. Elderly patients dose adjustment is not required.
Nebido women are not prescribed.
Dosing and Administration
Nebido must be administered intramuscularly (strictly) immediately after opening the ampoule. Injections must be made very slowly. Care should be taken to prevent the drug from entering the blood vessel.
Nebido solution is administered in a dose of 1 g (1 ampoule) 1 time in 10-14 weeks. With such a frequency of use of the drug is maintained testosterone at a sufficient level, and at the same time, the cumulation of the substance does not occur.
Before starting therapy, it is necessary to determine the amount of testosterone in serum. The first break between injections can be reduced, but it should not be less than 6 weeks. Css (stationary concentration of a substance) at such a dose is reached quickly.
Before each injection, it is necessary to measure the concentration of testosterone in serum. If its level is below the normal rate, it may be necessary to reduce the interval between injections. At high concentrations, it is necessary to consider the question of whether to increase the interval between use of the drug. However, the interval between injections should remain in the recommended range (10-14 weeks).
Most often with Nebido, acne and pain develop at the injection site.
During therapy, disturbances may also occur on the part of some body systems that manifest themselves with different frequencies (from ≥1 / 100 to <1/10 - often; from ≥1 / 1000 to <1/100 - infrequently):
- Cardiovascular system: often - tides; infrequently - dysfunction of the cardiovascular system, hypertension, increased blood pressure, dizziness;
- The digestive system: infrequently - diarrhea, nausea;
- Immune system: infrequently - hypersensitivity;
- Respiratory system, chest organs and mediastinum: infrequently - cough, sinusitis, snoring, shortness of breath, dysphonia, bronchitis;
- Nervous system: infrequently - migraine, headache, tremor;
- Blood and lymphatic system: often - polycythemia; infrequently - an increase in hematocrit, an increase in hemoglobin level and red blood cell count;
- Liver and biliary tract: infrequently - abnormal liver function tests, including an increase in aspartate aminotransferase activity;
- Musculoskeletal and connective tissue: infrequently - musculoskeletal stiffness, pain in the extremities, arthralgia, muscle spasms, myalgia, muscle tension, increased activity of creatine phosphokinase in blood;
- Skin and subcutaneous tissue: often - acne; infrequently - alopecia, erythema, rash, papular rash, itching, dry skin;
- Genitals and mammary glands: often - pathological results of examination of the prostate gland, an increase in the level of prostate-specific antigen, benign prostatic hyperplasia; infrequently - pain in the testicles, seal of the prostate gland, gynecomastia, intraepithelial neoplasia of the prostate gland, prostatitis, dysfunction of the prostate gland, increased or decreased libido, breast pain, tightness in the mammary gland, increased estradiol, testosterone, including and free testosterone in the blood;
- Kidneys and urinary tract: infrequently - a decrease in the volume of excreted urine, dysfunction of the urinary tract, urinary retention, nocturia, dysuria;
- Mind: infrequently - depression, insomnia, disturbances in the emotional sphere, aggression, anxiety, irritability;
- Metabolism and nutrition: often - an increase in body weight; infrequently - increased appetite, increased levels of glycated hemoglobin, hypercholesterolemia, increased levels of triglycerides and cholesterol in the blood;
- Disorders at the injection site and general disorders: often - various types of reactions at the injection site (swelling, pain, itching, discomfort, irritation, hematoma); infrequently - asthenia, fatigue, night sweats, hyperhidrosis.
During the clinical trials, as well as in the post-marketing period, rare cases of the development of a fatty microembolism of the pulmonary artery were reported. There is also evidence of the occurrence of anaphylactic reactions after administration of Nebido.
In addition to the above side effects, there were reports of the development of the following disorders:
- Aggression, nervousness, sleep apnea, various skin reactions (including seborrhea), increased erections, jaundice;
- Priapism (persistent painful erections);
- Reversible reduction or cessation of spermatogenesis, which can lead to a decrease in the size of the testicles (with high doses of testosterone);
- Fluid retention and edema (with prolonged therapy with high doses).
In elderly patients, with the use of Nebido, the risk of prostatic hyperplasia may increase, and therefore, before starting therapy with testosterone-containing drugs, prostate cancer must be excluded.
For prophylactic purposes, regular examination of the prostate gland is recommended.
Patients undergoing long-term treatment should periodically monitor hematocrit and hemoglobin to detect polycythemia.
Care must be taken with regard to patients who are prone to edema, since the use of Nebido can lead to delayed excretion of sodium ions.
If during therapy there are severe pains in the upper abdomen, the liver increases, and if there are signs of intra-abdominal bleeding, it is necessary for differential diagnosis to take into account the likelihood of a liver tumor.
With the use of Nebido, existing sleep apnea syndrome may increase.
Androgens should not be used to enhance muscle development and increase physical ability in healthy men.
The use of Nebido can reversibly reduce spermatogenesis.
To avoid pulmonary microembolism (manifested as coughing, shortness of breath, indisposition, hyperhidrosis, chest pain, dizziness, paresthesia, or fainting), Nebido solution should be injected very slowly intramuscularly.
The use of testosterone in the treatment of children with masculinization can lead to accelerated growth and maturation of the bone tissue, as well as premature closure of the growth zone of the epiphysis, which can cause a decrease in final growth. Also, therapy increases the likelihood of common acne.
With the simultaneous use of Nebido with certain drugs, the following effects may occur:
- Oxyphenbutazone: an increase in its concentration in serum;
- Insulin: enhancing its hypoglycemic effect (may require lower doses of hypoglycemic drugs);
- Drugs that induce microsomal enzymes (for example, barbiturates): an increase in testosterone clearance;
- Oral anticoagulants: an increase in their activity, which may lead to the need for dose adjustment.
Due to the lack of necessary data on possible interactions, Nebido should not be mixed with other drugs.
Terms and conditions of storage
Keep out of reach of children at temperature up to 25 ° C.
Shelf life - 5 years.