Posology : מינונים

4.2   Posology and method of administration
Norditropin should only be prescribed by doctors with special knowledge of the therapeutic indication of use.


NOR NOR SPC July21-Notification
Posology
The dosage is individual and must always be adjusted in accordance with the individual's clinical and biochemical response to therapy.

Generally recommended dosages:

Paediatric population:
Growth hormone insufficiency
0.025-0.035 mg/kg/day or 0.7-1.0 mg/m2/day
When GHD persists after growth completion, growth hormone treatment should be continued to achieve full somatic adult development including lean body mass and bone mineral accrual (for guidance on dosing, see Replacement therapy in adults).

Turner syndrome
0.045-0.067 mg/kg/day or 1.3-2.0 mg/m2/day

Pediatric patients with short stature associated with Noonan syndrom A dosage of up to 0.066 mg/kg/day is recommended.

Chronic renal disease
0.050 mg/kg/day or 1.4 mg/m2/day (see section 4.4)

Small for Gestational Age
0.035 mg/kg/day or 1.0 mg/m2/day
A dose of 0.035 mg/kg/day is usually recommended until final height is reached (see section 5.1).
Treatment should be discontinued after the first year of treatment, if the height velocity SDS is below +1.
Treatment should be discontinued if height velocity is < 2 cm/year and, if confirmation is required, bone age is > 14 years (girls) or > 16 years (boys), corresponding to closure of the epiphyseal growth plates.

Adult population:

Replacement therapy in adults
The dosage must be adjusted to the need of the individual patient.
In patients with childhood onset GHD, the recommended dose to restart is 0.2-0.5 mg/day with subsequent dose adjustment on the basis of IGF-1 concentration determination.
In patients with adult onset GHD, it is recommended to start treatment with a low dose: 0.1- 0.3 mg/day. It is recommended to increase the dosage gradually at monthly intervals based on the clinical response and the patient’s experience of adverse events. Serum IGF-1 can be used as guidance for the dose titration. Women may require higher doses than men, with men showing an increasing IGF-1 sensitivity over time. This means that there is a risk that women, especially those on oral oestrogen replacement are undertreated while men are overtreated.
Dose requirements decline with age. Maintenance dosages vary considerably from person to person, but seldom exceed 1.0 mg/day.

Method of administration
Generally, daily subcutaneous administration in the evening is recommended. The injection site should be varied to prevent lipoatrophy.


NOR NOR API JUL21-Notification