Increlex® is used to treat children who are very short for their age because their bodies do not make enough IGF-1. This condition is called severe primary IGF-1 deficiency. Increlex® should not be used for other causes of growth failure and should not be used instead of growth hormone.
Increlex® is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (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 ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH).
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 antiinflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating Increlex® treatment. Increlex® is not a substitute to GH for approved GH indications. Increlex® has not been studied in children < 2 years of age.