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Humatrope ® (somatropin)
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Humatrope® (somatropin): Undesirable effects
Summary of the safety profile of somatropin
The following table of undesirable effects and frequencies is based on clinical trial and post-marketing spontaneous reports.
Immune system disorders
Hypersensitivity to solvent (metacresol/glycerol): 1%-10%.
Hypersensitivity to the active substance: Frequency not known (cannot be estimated from the available data).
Reproductive system and breast disorders
Metabolism and nutrition disorders
Mild hyperglycaemia: 1% paediatrics; 1%-10% adults.
Type 2 diabetes mellitus: 0.1 % - 1 % paediatrics; adult cases were reported spontaneously with unknown frequency.
Nervous system disorders
Benign intracranial hypertension: 0.01%-0.1%.
Headache: >10% adults.
Insomnia: <0.01% paediatrics; 1%-10% adults.
Paraesthesia: 0.01%-0.1% paediatrics; 1%-10% adults.
Carpal tunnel syndrome: 1%-10% adults.
Hypertension: <0.01% paediatrics; 1%-10% adults.
Respiratory, thoracic and mediastinal disorders
Dyspnoea: 1%-10% adults.
Sleep apnoea: 1%-10% adults.
Musculoskeletal and connective tissue disorders
Localised muscle pain (myalgia): 1%-10% adults; 0.01%-0.1% paediatrics.
Joint pain and disorder (arthralgia): >10% adults.
Progression of scoliosis: 1 %-10 % paediatrics.
General disorders and administration site conditions
Injection site pain (reaction): 1%-10%.
Oedema (local and generalised): 1%-10% paediatrics; 10% adults.
Glucosuria: <0.01% paediatrics; 0.01%-0.1% adults.
In clinical trials with growth hormone deficient patients, approximately 2% of the patients developed antibodies to growth hormone. In trials in Turner syndrome, where higher doses were used, up to 8% of patients developed antibodies to growth hormone. The binding capacity of these antibodies was low and growth rate was not affected adversely. Testing for antibodies to growth hormone should be carried out in any patient who fails to respond to therapy.
A mild and transient oedema was observed early during the course of treatment.
Leukaemia has been reported in a small number of children who have been treated with growth hormone. However, there is no evidence that leukaemia incidence is increased in growth hormone recipients without predisposing factors.
In patients with adult onset growth hormone deficiency, oedema, muscle pain and joint pain and disorder, were reported early in therapy and tended to be transient.
Adult patients treated with growth hormone, following diagnosis of growth hormone deficiency in childhood, reported side-effects less frequently than those with adult onset growth hormone deficiency.
Humatrope Summary of Product Characteristics.
Date of Last Review: 09 February 2022