Norditropin NordiFlex

Norditropin NordiFlex Adverse Reactions

somatropin

Manufacturer:

Novo Nordisk

Distributor:

DKSH
Full Prescribing Info
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 paresthesia may also occur, but are usually self-limiting.
Adverse reactions in children are uncommon or rare.
Clinical trial experience: See table.

Click on icon to see table/diagram/image

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 previously 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: Hyperglycemia (see Precautions).
Nervous system disorders: Benign intracranial hypertension (see Precautions).
Musculoskeletal and connective tissue disorders: Slipped capital femoral epiphysis. Slipped capital femoral epiphysis may occur more frequently in patients with endocrine 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.
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 national reporting system listed in Appendix V.
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