תבנית:תרופה/אינקרלקס - Increlex: הבדלים בין גרסאות

INCRELEX (mecasermin [rDNA origin] injection) is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe Primary IGFD is defined by: - height standard deviation score lower or equal to -3.0 and - basal IGF-1 standard deviation score lower or equal to -3.0 and - basal IGF-1 levels below the 2.5th percentile for age and gender and - normal or elevated growth hormone (GH). Severe Primary IGFD includes patients with mutations in the GH receptor (GHR) post-GHR signaling pathway, and IGF-1 gene defects they are not GH deficient and therefore they cannot be expected to respond adequately to exogenous GH treatment. INCRELEX is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment. INCRELEX is not a substitute for GH treatment.