Adult & childhood onset growth hormone deficiency (GHD). In childn, growth failure due to GHD, growth failure in girls due to gonadal dysgenesis (Turner syndrome), growth retardation in prepubertal childn due to chronic renal disease & short childn born small for gestational age (SGA), who failed to show catch-up growth by 4 yr.
Hypersensitivity. Evidence of tumour activity; discontinue if there is evidence of tumour growth. Longitudinal growth promotion in childn w/ closed epiphyses. Acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. For childn w/ chronic renal disease, treatment w/ Norditropin NordiFlex should be discontinued at renal transplantation. Pregnancy & lactation.
Adults: Patients w/ previous malignant disease, leukemia, benign intracranial HTN. Monitor thyroid function; patients w/ diabetes or glucose intolerance. Test for Abs to somatropin in any patient who fails to respond to therapy. Previously undiagnosed central (secondary) hypoadrenalism may be unmasked & glucocorticoid replacement may be required. Somatropin dose may be increased in women concomitantly receiving oral oestrogen therapy; evaluate patients. Limited experience in patients >60 yr & w/ >5 yr GHD treatment. Childn: Regularly assessed by a specialist in child growth. Patients w/ Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnoea, or unidentified resp infection. Rule out other medical reasons that could explain growth disturbance in short childn born SGA before starting treatment. Not recommended to initiate treatment near onset of puberty. Silver-Russell syndrome. Monitor growth of hands & feet in Turner syndrome; signs of scoliosis; renal function in patients w/ chronic renal disease. Otological evaluation on at least an annual basis in girls w/ Turner syndrome. Measure fasting insulin & blood glucose prior to treatment & annually thereafter in Turner syndrome & SGA; IGF-1 level prior to treatment & twice a yr thereafter in Turner syndrome & SGA. Perform oral glucose tolerance testing in patients w/ increased risk of DM. Not recommended in women of childbearing potential not using contraception & during pregnancy. Lactation.
Concomitant treatment w/ glucocorticoids inhibits the growth promoting effect of somatropin. In women on oral oestrogen replacement, a higher dose of growth hormone may be required to achieve the treatment goal. Somatropin may increase the clearance of compd metabolised by CP450 3A4 (eg, sex steroids, corticosteroids, anticonvulsants & cyclosporine). Somatropin effect can be influenced by additional therapy w/ other hormones eg, gonadotropin, anabolic steroids, oestrogen & thyroid hormone. Insulin dose adjustment may be needed after initiation of somatropin treatment.
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