Norditropin Nordiflex Adverse Reactions

Growth hormone deficient patients are characterised by extracellular volume deficit. When treatment with somatropin is initiated, this deficit is corrected. Fluid retention with peripheral oedema may occur especially in adults. Carpal tunnel syndrome is uncommon but may be seen in adults. The symptoms are usually transient, dose dependent and may require transient dose reduction.
Mild arthralgia, muscle pain and paraesthesia may also occur, but are usually self-limiting.
Adverse reactions in children are uncommon or rare.
Clinical trial experience: Children may experience the following: Uncommon effects (≥1/1,000 to <1/100): Injection site reaction, Injection site pain, Headache.
Rare effects (≥1/10,000 to <1/1,000): Arthralgia and myalgia, Peripheral oedema, Rash.
Adults may experience the following: Very common effects (≥1/10): Peripheral oedema.
Common effects (≥1/100 to <1/10): Headache and paraesthesia, Arthralgia, joint stiffness and myalgia.
Uncommon effects (≥1/1,000 to <1/100): Carpal tunnel syndrome, Injection site pain, Pruritus, Muscle stiffness, Type 2 diabetes mellitus.
In children with Turner syndrome increased growth of hands and feet has been reported during somatropin therapy.
A tendency for increased incidence of otitis media in Turner syndrome patients treated with high doses of Norditropin has been observed in one open-label randomised clinical trial. However, the increase in ear infections did not result in more ear operations/ tube insertions compared to the lower dose group in the trial.
Post-marketing experience: In addition to the above-mentioned adverse drug reactions, those presented as follows have been spontaneously reported and are by an overall judgement considered possibly related to Norditropin treatment. Frequencies of these adverse events cannot be estimated from the available data: Neoplasms benign and malignant (including cysts and polyps): Leukaemia has been reported in a small number of growth hormone deficiency patients (see Precautions).
Immune system disorders: Hypersensitivity (see Contraindications). Formation of antibodies directed against somatropin. The titres and binding capacities of these antibodies have been very low and have not interfered with the growth response to Norditropin administration.
Endocrine disorders: Hypothyroidism. Decrease in serum thyroxin levels (see Precautions).
Metabolism and nutrition disorders: Hyperglycaemia (see Precautions).
Nervous system disorders: Benign intracranial hypertension (see Precautions).
Musculoskeletal and connective tissue disorders: Legg-Calvé-Perthes disease. Legg-Calvé-Perthes disease may occur more frequently in patients with short stature.
Investigations: Increase in blood alkaline phosphatase level.