DECA-DURABOLIN Solution for injection Ref.[8497] Active ingredients: Nandrolone

Medical examination

Physicians should consider monitoring patients receiving Deca-Durabolin before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

• Hematocrit and hemoglobin to exclude polycythemia.

Conditions that need supervision

Patients, especially the elderly, with the following conditions should be monitored for:

• Tumours: Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, and also during androgen therapy. Nevertheless, the hypercalcaemia or hypercalciuria should first be treated appropriately and after restoration of normal calcium levels, if judged necessary and taking into account the risks and benefits on a case by case basis, hormone therapy can be resumed, with caution.
• Pre-existing conditions: In patients with pre-existing cardiac, renal or hepatic insufficiency/disease or epilepsy or migraine anabolic steroid treatment may cause complications characterized by oedema with or without congestive heart failure. In such cases treatment must be stopped immediately. Patients who experienced myocardial infarction, cardiac-, hepatic- or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration of or reoccurrence of disease. In such cases treatment must be stopped immediately.
• Diabetes mellitus: Deca-Durabolin can improve glucose tolerance in diabetic patients (see section 4.5).
• Anti-coagulant therapy: Deca-Durabolin can enhance the anti-coagulant action of coumarin-type agents (see also section 4.5).
• Liver dysfunction: caution should be used in patients with severe hepatic impairment and Deca-Durabolin 50mg/ml should only be used if the benefits outweigh the risks.

Adverse events

If anabolic steroid-associated adverse reactions occur (see section 4.8), treatment with Deca-Durabolin should be discontinued and, upon resolution of complaints, treatment can be resumed.

Virilisation

Patients should be informed about the potential occurrence of signs of virilisation. In particular, singers and women with speech professions should be informed about the risk of deepening of the voice.

If signs of virilisation develop, the risk/benefit ratio has to be newly assessed with the individual patient.

(Mis) use in sports

Nandrolone is classified as a prohibited substance under the Olympic Movement Anti- doping Code (OMAC 1999). The misuse of Nandrolone and other anabolic steroids to enhance ability in sports carries serious health risks and is to be discouraged.

Drug abuse and dependence

Anabolic androgenic steroids have been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with testosterone. Abuse of anabolic androgenic steroids including testosterone can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Anabolic androgenic steroid abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of anabolic androgenic steroids including testosterone carries serious health risks and is to be discouraged.

Excipients

Deca-Durabolin contains arachis oil (peanut oil) and should not be taken/applied by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Deca-Durabolin (see section 4.3).

Deca-Durabolin 50mg/ml contains 100 mg benzyl alcohol per ml solution and must not be given to premature babies or neonates. Benzyl alcohol may cause anaphylactoid reactions in infants and children up to 3 years old.

Paediatric Population

Safety and efficacy have not been adequately determined in children and adolescents. In pre-pubertal children statural growth and sexual development should be monitored since anabolic steroids in general and Deca-Durabolin in high dosages may accelerate epiphyseal closure and sexual maturation.

Enzyme-inducing agents may decrease and enzyme-inhibiting drugs may increase nandrolone levels. Therefore, adjustment of the dose of Deca-Durabolin may be required.

Insulin and other anti-diabetic medicines

Anabolic steroids may improve glucose tolerance and decrease the need for insulin or other anti-diabetic drugs in diabetic patients (see section 4.4). Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Deca-Durabolin treatment.

Anti-coagulant therapy

High doses of Deca-Durabolin may enhance the anti-coagulant action of coumarin- type agents (see section 4.4). Therefore close monitoring of prothrombin time and if necessary a dose reduction of the anti-coagulant is required during therapy.

ACTH or corticosteroids

The concurrent administration of anabolic steroids with ACTH or corticosteroids may enhance edema formations; thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patient predisposed to edema (see section 4.4).

Laboratory test interactions

Anabolic steroids may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increases resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Recombinant Human Erythropoietin

Combination of Deca-Durabolin with rhEPO (recombinant human erythropoietin), especially in females, may enable a reduction of the erythropoietin dose to reduce anemia.

Deca-Durabolin is contra-indicated in women who are pregnant (see section 4.3).

Pregnancy

There are no adequate data for the use of Deca-Durabolin in pregnant women. In view of the risk of virilisation of the foetus, Deca-Durabolin should not be used during pregnancy. Treatment with Deca-Durabolin should be discontinued when pregnancy occurs.

Lactation

There are no adequate data for the use of this medicine during lactation to assess potential harm to the infant or a possible influence on milk production. Therefore, Deca-Durabolin should not be used during lactation.

Fertility

In men treatment with Deca-Durabolin can lead to fertility disorders by repressing sperm-formation. In women treatment with androgens can lead to an infrequent or repressed menstrual cycle (see section 4.8).

Deca-Durabolin has no influence on the ability to drive and use machines.

Due to the nature of Deca-Durabolin, side effects cannot be quickly reversed by discontinuing medication. Injectables in general, may cause local reaction at the injection site.

Deca-Durabolin at the recommended dosages is unlikely to produce virilising effects. High dosages, prolonged treatment and/or too frequent administration may cause:

Endocrine disorders: Virilism

Metabolism and nutrition disorders: Lipids abnormal¹

Psychiatric disorders: Libido increased

Vascular disorders: Hypertension

Respiratory, thoracic and mediastinal disorders: Dysphonia

Gastrointestinal disorders: Nausea

Hepatobiliary disorders: Hepatic function abnormal, Peliosis hepatis, Liver tumours

Skin and subcutaneous tissue disorders: Acne, Pruritus, Hirsutism

Renal and urinary disorders: Urine flow decreased

Reproductive system and breast disorders: Enlarged clitoris

General disorders and administration site conditions: Oedema, Injection site reaction, Sodium retention

Investigations: Haemoglobin increased

¹ Decrease in serum LDL-C, HDL-C and triglycerides.

Virilisation which appears in sensitive women as hoarseness, acne, hirsutism and increase of libido. Hoarseness may be the first symptom of vocal change which may end in long-lasting, sometimes irreversible deepening of the voice.

The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

None known.