Norditropin NordiLet

Norditropin NordiLet Special Precautions

somatropin

Manufacturer:

Novo Nordisk

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
Do not use Norditropin NordiLet if the growth hormone solution in the pre-filled pen is cloudy or discoloured. Check this by turning the pen upside down once or twice. To ensure proper dosing and avoid injection of air, check the flow (prime the pen) before the first injection from a new Norditropin NordiLet pen. Do not use Norditropin NordiLet if a drop of growth hormone solution does not appear at the needle tip.
Children treated with somatropin should be regularly assessed by a specialist in child growth. Somatropin treatment should always be instituted by a physician with special knowledge of growth hormone deficiency and its treatment. This is true also for the management of Turner syndrome, chronic renal disease and SGA.
The maximum recommended daily dose should not be exceeded.
The stimulation of longitudinal growth in children can only be expected until the epiphysial discs are closed.
Growth hormone deficiency in adults: Growth hormone deficiency in adults is a lifelong disease and needs to be treated accordingly. However, experience in patients older than 60 years of age and in patients with more than 10 years of treatment in adult growth hormone deficiency is still limited.
Turner syndrome: Monitoring of growth of hands and feet in Turner syndrome patients treated with growth hormone is recommended, and a dose reduction to the lower part of the dose range should be considered if increased growth is observed.
Girls with Turner syndrome generally have an increased risk of otitis media, which is why careful otological evaluation is recommended.
Chronic renal disease: The growth retardation in children with chronic renal disease should be clearly established before somatropin treatment by following growth on optimal treatment for renal disease over one year. Conservative management of uraemia with customary medication and if needed dialysis should be maintained during somatropin therapy.
Patients with chronic renal disease normally experience a decline in renal function as part of the natural course of their illness. However, as a precautionary measure during somatropin treatment, renal function should be monitored for an excessive decline or increase in the glomerular filtration rate (which could imply hyperfiltration).
Neoplasms: There is no evidence for increased risk of new primary cancers in children or adults treated with somatropin.
In patients in complete remission from tumours or malignant disease, somatropin therapy has not been associated with an increased relapse rate.
An overall slight increase in second neoplasms has been observed in childhood cancer survivors treated with growth hormone, with the most frequent being intracranial tumours. The dominant risk factor for second neoplasms seems to be prior exposure to radiation.
Patients who have achieved complete remission of malignant disease should be followed closely for relapse after commencement of somatropin therapy.
Benign intracranial hypertension: Very rare cases of benign intracranial hypertension have been reported. If appropriate, somatropin treatment should be discontinued.
In the event of severe or recurrent headache, visual problems, nausea, and/or vomiting, a funduscopy for papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial hypertension should be considered, and if appropriate, the growth hormone treatment should be discontinued.
At present there is insufficient evidence to guide clinical decision making in patients with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring for symptoms of intracranial hypertension is necessary.
Patients with growth hormone deficiency secondary to an intracranial lesion should be examined frequently for progression or recurrence of the underlying disease process.
Thyroid function: Somatropin increases the extrathyroidal conversion of T4 to T3, and may as such unmask incipient hypothyroidism.
As hypothyroidism interferes with the response of somatropin therapy, patients should have their thyroid function tested regularly and should receive replacement therapy with thyroid hormone when indicated.
Patients with Turner syndrome have an increased risk of developing primary hypothyroidism associated with antithyroid antibodies.
Scoliosis: Scoliosis may progress in any child during rapid growth. Signs of scoliosis should be monitored during treatment. However, growth hormone treatment has not been shown to increase the incidence or severity of scoliosis.
Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders, and Legg-Calvé-Perthes disease may occur more frequently in patients with short stature. These diseases may present as the development of a limp or complaints of hip or knee pain and physicians and parents should be alerted to this possibility.
Carbohydrate metabolism: Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients, and consequently hyperglycaemia may occur in subjects with inadequate insulin secretory capacity. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment.
Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome or a family history of diabetes mellitus. Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycaemic drugs (i.e. insulin or oral agents) may require adjustment when somatropin therapy is instituted in these patients.
IGF-I: It is recommended to measure the IGF-I level before start of treatment and regularly thereafter.
There have been reports of fatalities after initiating therapy with growth hormone in paediatric patients with Prader-Willi syndrome, for which Norditropin is not approved. Fatalities were reported in patients who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified respiratory infection.
Norditropin NordiLet replacement in adult GHD patients should preferably be monitored by an endocrinologist with special experience in pituitary disease.
Effects on ability to drive and use machinery: No influence on the ability to drive and use machinery.
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