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1 Indications And Usage Increlex (Mecasermin) Injection Is Indicated For The Treatment Of Growth Failure In Pediatric Patients 2 Years Of Age And Older With Severe Primary Igf-1 Deficiency Or With Growth Hormone (Gh) Gene Deletion Who Have Developed Neutralizing Antibodies To Gh. (1.1) Limitations Of Use: Increlex Is Not A Substitute To Gh For Approved Gh Indications. Severe Primary Igf-1 Deficiency (Primary Igfd) Increlex Is Indicated For The Treatment Of Growth Failure In Pediatric Patients 2 Years Of Age And Older With: Severe Primary Igf-1 Deficiency Or Growth Hormone (Gh) Gene Deletion Who Have Developed Neutralizing Antibodies To Gh. Severe Primary Igf-1 Deficiency (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). Limitations Of Use: Increlex Is Not A Substitute To Gh For Approved Gh Indications. Increlex Is Not Indicated For Use In Patients With Secondary Forms Of Igf-1 Deficiency, Such As Gh Deficiency, Malnutrition, Hypothyroidism, Or Chronic Treatment With Pharmacologic Doses Of Anti-Inflammatory Corticosteroids.
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