Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Ipsen Pharma, 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
In adults with growth hormone deficiency the diagnosis should be established depending on the etiology:
Adult-onset: The patient must have growth hormone deficiency as a result of hypothalamic or pituitary disease, and at least one other hormone deficiency diagnosed (except for prolactin). Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted.
Childhood-onset: Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
Diagnosis and therapy with somatropin should be initiated and monitored by physicians who are appropriately qualified and experienced in the diagnosis and management of patients with the therapeutic indication of use.
The NutropinAq dosage and administration schedule should be individualised for each patient.
0.025-0.035 mg/kg bodyweight given as a daily subcutaneous injection.
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
Up to 0.05 mg/kg bodyweight given as a daily subcutaneous injection.
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed.
Up to 0.05 mg/kg bodyweight given as a daily subcutaneous injection.
Somatropin therapy should be continued in children and adolescents until their epiphysis are closed, or up to the time of renal transplantation.
At the start of somatropin therapy, low initial doses of 0.15-0.3 mg are recommended, given as a daily subcutaneous injection. The dose should be adjusted stepwise, controlled by serum Insulin-like Growth Factor-1 (IGF-I) values. The recommended final dose seldom exceeds 1.0 mg/day. In general, the lowest efficacious dose should be administered. In older or overweight patients, lower doses may be necessary.
Women may require higher doses than men, with men showing an increasing IGF-I sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen therapy, are under-treated while men are over-treated.
The solution for injection should be administered subcutaneously each day. The site of injection should be changed.
NutropinAq is supplied as a multi-dose solution. After removal from the refrigerator, if the solution is cloudy, the content must not be injected. Gently swirl. Do not shake vigorously as it could denature the protein. NutropinAq is intended for use only with the NutropinAq Pen.
For instructions for use and handling of the medicinal product, see section 6.6.
Acute overdose could lead to hyperglycaemia. Long-term overdose could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone.
Treatment is symptomatic and supportive. There is no antidote for somatropin overdose. It is recommended to monitor thyroid function following an overdose.
2 years.
Chemical and physical in-use stability has been demonstrated for 28 days at 2°C-8°C.
From a microbiological point of view, once opened, the product may be stored for a maximum of 28 days at 2°C-8°C. NutropinAq is designed to withstand a nominal (one hour maximum) period of time outside of the refrigerator on a daily basis.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the blister in the outer carton
For in-use storage conditions of the medicinal product, see section 6.3.
2 ml of solution in a cartridge (Type I glass) closed with a stopper (butyl rubber) and a seal (rubber).
Pack sizes of 1, 3 and 6 cartridges.
Not all pack sizes may be marketed.
No special requirements.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
NutropinAq is supplied as a multi-dose solution. After removal from the refrigerator, if the solution is cloudy, the content must not be injected. Gently swirl. Do not shake vigorously as it could denature the protein.
NutropinAq is intended for use only with the NutropinAq Pen. Wipe the rubber seal of the NutropinAq with rubbing alcohol or an antiseptic solution to prevent contamination of the contents by microorganisms that may be introduced by repeated needle insertions. It is recommended that NutropinAq be administered using sterile, disposable needles.
The NutropinAq Pen allows for administration of a minimum dose of 0.1 mg to a maximum dose of 4.0 mg, in 0.1 mg increments.
A cartridge that is in the pen should not be removed during injections.
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