Saizen Dosage/Direction for Use

Saizen is intended for multiple dose use in an individual patient.
Saizen dosage should be individualised for each patient based on body surface area (BSA) or on body weight (BW).
Posology: 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 (BW) per day by subcutaneous administration or intramuscular administration.
Growth failure in girls due to gonadal dysgenesis (Turner Syndrome): 1.4 mg/m² body surface area (BSA) per day or 0.045-0.050 mg/kg body weight (BW) 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 (BSA), approximately equal to 0.045-0.050 mg/kg body weight (BW), 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 U/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.
Adults: 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 replacement 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 Pharmacology: Pharmacokinetics under Actions but no recommendation on a posology can be made.
Method of administration: For administration of the solution for injection of Saizen follow the instructions given in the package leaflet and in the instruction manual provided with the selected injector: cool.click needle-free auto-injectors, easypod auto-injector or aluetta pen 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.
For instructions for handling please see Special precautions for disposal and other handling under Cautions for Usage.