Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Humatrope ® (somatropin)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
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). |
|
Endocrine disorders Hypothyroidism: 1%-10%. |
|
Reproductive system and breast disorders Gynaecomastia: 0.1%-1% |
|
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. Insulin resistance. |
|
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. |
|
Vascular disorders 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 Weakness: 0.1%-1%. Injection site pain (reaction): 1%-10%. Oedema (local and generalised): 1%-10% paediatrics; 10% adults. |
|
Investigations Glucosuria: <0.01% paediatrics; 0.01%-0.1% adults. |
Paediatric patients
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.
Adult patients
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.
Reference
Humatrope Summary of Product Characteristics.
Date of Last Review: 09 February 2022