Nebido by Bayer

Nebido - Bayer

1. Name of the medicinal product

Nebido 1000 mg/4 ml, solution for injection.

2. Qualitative and quantitative composition

Each ml solution for injection contains 250 mg testosterone undecanoate corresponding to 157.9 mg testosterone.
Each ampoule / vial with 4 ml solution for injection contains 1000 mg testosterone undecanoate corresponding to 631.5 mg testosterone.

3. Pharmaceutical form

Solution for injection.
Clear, yellowish oily solution.

4. Therapeutic indications

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Examples of hypogonadal disorder are:

  • after castration
  • eunuchoidism
  • hypopituitarism
  • endocrine impotence
  • male climacteric symptoms like decreased libido and decreased mental and physical activity
  • certain types of infertility due to disorders of spermatogenesis

Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.

5. Dosage of administration

In general, the dose should be adjusted according to the response of the individual patient.

Adults
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.

Elderly Patients
Limited data do not suggest the need for a dosage adjustment in elderly patients.

Paediatric population
Nebido is not indicated for use in children and adolescents and it has not been clinically evaluated in males under 18 years of age.

6. Method of administration

For intramuscular use.
The injections must be administered very slowly (over two minutes). Nebido is strictly for intramuscular injection. Care should be taken to inject Nebido deeply into the gluteal muscle following the usual precautions for intramuscular administration. Special care must be taken to avoid intravasal injection. The contents of an ampoule / vial are to be injected intramuscularly immediately after opening.

7. Side effects

The most frequently reported undesirable effects during treatment with Nebido are acne and injection site pain.
Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injection and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported rarely in clinical trials (in ≥ 1/10,000 and < 1/1,000 injections) as well as from postmarketing experience. Suspected anaphylactic reactions after Nebido injection have been reported. Androgens may accelerate the progression of sub-clinical prostatic cancer and benign prostatic hyperplasia. Table 1 below reports adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Nebido. The frequencies are based on clinical trial data and defined as common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to <1/100) and rare (≥ 1/10,000 to < 1/1,000). The ADRs were recorded in 6 clinical studies (N=422) and considered at least possibly causally related to Nebido.

System Organ Class Common
(≥ 1/100 to < 1/10)
Uncommon
(≥ 1/1000 to <1/100)
Rare
(≥ 1/10,000 to < 1/1,000)
Blood and lymphatic system disorders Polycythaemia

Haematocrit increased *

Red blood cell count increased *

Haemoglobin increased *

Immune system disorders Hypersensitivity
Metabolism and nutrition disorders Weight increased

Increased appetite

Glycosylated haemoglobin increased

Hypercholesterolaemia

Blood triglycerides increased

Blood cholesterol increased

Psychiatric disorders Depression

Emotional disorder

Insomnia

Restlessness

Aggression

Irritability

Nervous system disorders Headache

Migraine

Tremor

Vascular disorders Hot flush Cardiovascular disorder

Hypertension

Dizziness

Respiratory, thoracic and mediastinal disorders Bronchitis

Sinusitis

Cough

Dyspnoea

Snoring

Dysphonia

Gastrointestinal disorders Diarrhoea

Nausea

Hepatobiliary disorders Liver function test abnormal

Aspartate aminotransferase increased

Skin and subcutaneous tissue disorders Acne Alopecia

Erythema

Rash 1

Pruritus

Dry skin

Musculoskeletal and connective tissue disorders Arthralgia

Pain in extremity

Muscle disorders 2

Musculoskeletal stiffness

Blood creatine phosphokinase increased

Renal and urinary disorders Urine flow decreased

Urinary retention

Urinary tract disorder

Nocturia

Dysuria

Reproductive system and breast disorders Prostate specific antigen increased

Prostate examination abnormal

Benign prostate hyperplasia

Prostatic intraepithelial neoplasia

Prostate induration

Prostatitis

Prostatic disorder

Libido changes

Testicular pain

Breast induration

Breast pain

Gynaecomastia

Oestradiol increased

Testosterone increased

General disorders and administration site conditions Various kinds of injection site reactions 3 Fatigue

Asthenia

Hyperhidrosis 4

Injury, poisoning and procedural complications Pulmonary oil microembolism **

* Respective frequency has been observed in relation to the use in testosterone containing products.
** Frequency is based on the number of injections.
The most appropriate MedDRA term to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
1 Rash including Rash papular
2 Muscle disorders: Muscle spasm, Muscle strain and Myalgia
3 Various kinds of injection site reaction: Injection site pain, Injection site discomfort, Injection site pruritus, Injection site erythema, Injection site haematoma, Injection site irritation, Injection site reaction
4 Hyperhidrosis: Hyperhidrosis and Night sweats

Description of selected adverse reactions
Pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia, or syncope. These reactions may occur during or immediately after the injections and are reversible. Cases suspected by the company or the reporter to represent oily pulmonary microembolism have been reported rarely in clinical trials (in ≥ 1/10,000 and < 1/1,000 injections) as well as from postmarketing experience. In addition to the above mentioned adverse reactions, nervousness, hostility, sleep apnoea, various skin reactions including seborrhoea, increased hair growth, increased frequency of erections and in very rare cases jaundice have been reported under treatment with testosterone containing preparations. Therapy with high doses of testosterone preparations commonly reversibly interrupts or reduces spermatogenesis, thereby reducing the size of the testicles; testosterone replacement therapy of hypogonadism can in rare cases cause persistent, painful erections (priapism). High-dosed or long-term administration of testosterone occasionally increases the occurrences of water retention and oedema.

8. Shell life

5 years

The medicinal product must be used immediately after first opening.

Nebido by Bayer