Saizen is indicated in the 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; 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 fulfill 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.