Saizen is indicated in the treatment of:
Children and adolescents:
– Growth failure in children caused by decreased or absent secretion of endogenous growth hormone.
– Growth failure in girls with gonadal dysgenesis (Turner syndrome), confirmed by chromosomal analysis.
– Growth failure in prepubertal children due to chronic renal failure (CRF).
– Growth disturbance (current height SDS <-2.5 and parental adjusted height SDS <-1) in short children born small for gestational age (SGA) with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last year) by 4 years of age or later.
– Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test for growth hormone deficiency. Patients must also fulfil the following criteria:
|– Childhood onset:
Patients who were diagnosed as growth hormone deficient during childhood, must be retested and their growth hormone deficiency confirmed before replacement therapy with Saizen is started.
– Adult onset:
Patients must have growth hormone deficiency as a result of hypothalamic or pituitary disease and at least one other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.
Saizen 8 mg click.easy is intended for multiple dose use.
Saizen dosage should be individualised for each patient based on body surface area or on body weight.
It is recommended that Saizen be administered at bedtime according to the following dosage:
Children and adolescents:
– Growth failure due to inadequate endogenous growth hormone secretion:
0.7-1.0 mg/m2 body surface area per day or 0.025-0.035 mg/kg body weight per day by subcutaneous administration.
– Growth failure in girls due to gonadal dysgenesis (Turner syndrome):
1.4 mg/m2 body surface area per day or 0.045-0.050 mg/kg body weight per day by subcutaneous administration.
Concomitant therapy with non-androgenic anabolic steroids in patients with Turner syndrome can enhance the growth response.
– Growth failure in prepubertal children due to chronic renal failure (CRF):
1.4 mg/m2 body surface area per day, approximately equal to 0.045-0.050 mg/kg body weight per day by subcutaneous administration.
– Growth failure in short children born small for gestational age (SGA):
The recommended daily dose is 0.035 mg/kg body weight (or 1 mg/m2/day, equal to 0.1 IU kg/day or 3 IU m2/day) per day, by subcutaneous administration.
Treatment should be discontinued when the patient has reached a satisfactory adult height, or the epiphyses are fused.
For growth disturbance in short children born SGA, treatment is usually recommended until final height is reached. Treatment should be discontinued after the first year if height velocity SDS is below +1. Treatment should be discontinued when final height is reached (defined as height velocity <2 cm/year), and if confirmation is required if bone age is >14 years (girls) or >16 years (boys), corresponding to closure of the epiphyseal growth plates.
Growth hormone deficiency in adults
At the start of somatropin therapy, low doses of 0.15-0.3 mg are recommended, given as a daily subcutaneous injection. The dose should be adjusted stepwise, controlled by Insulin-like Growth Factor 1 (IGF-1) values. The recommended final growth hormone dose seldom exceeds 1.0 mg/day. In general the lowest efficacious dose should be administered.
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 therapy are under-treated while men are over-treated.
In older or overweight patients, lower doses may be necessary.
Patients with renal or hepatic impairment
Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Method of administration
For administration of the reconstituted solution for injection of Saizen 8 mg click.easy follow the instructions given in the package leaflet and in the instruction manual provided with the selected auto-injector: one.click auto-injector, cool.click needle-free auto-injectors or easypod auto-injector.
Intended users of easypod are primarily children starting from the age of 7 up to adults. Use of the devices by children should always be made under adult’s supervision.
The powder for solution for injection must be reconstituted with the enclosed bacteriostatic solvent (0.3% (w/v) metacresol solution in water for injections) for parenteral use, using the click.easy reconstitution device. For instructions for preparation please see section 6.6.