Treatment of 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; retarded growth in children born small for their gestational age defined as follows: Present height <-2.5 SDS and the SDS of the adjusted height of the parents is <-1; weight and/or height at birth <-2 SDS, in children who have not reached their normal growth rate by the age of ≥4 years (ie, with a growth rate <0 SDS in the course of the last year).
Adults with pronounced growth hormone deficiency with onset in childhood or adulthood. The deficiency must be confirmed by 2 dynamic tests, 1 of which must preferably be the GHRH + arginine test. If deficit of a further pituitary axis is detected, 1 single test is sufficient. The tests must be carried out under adequate substitution of the other hormone deficiencies.
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 1 other hormone deficiency diagnosed (except for prolactin) and adequate replacement therapy instituted, before replacement therapy using growth hormone may begin.