INCRELEX SUMMARY
INCRELEX™ (mecasermin [rDNA origin] injection)
INCRELEX™ (mecasermin [rDNA origin] injection) is an aqueous solution for injection containing human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology.
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:
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height standard deviation score ≤–3.0 and
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basal IGF-1 standard deviation score ≤–3.0 and
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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.
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