At a glance
| Product | Increlex |
|---|---|
| Active hormone | Recombinant IGF-1 |
| Age scope | 2 years and older |
| Primary use | Severe primary IGF-1 deficiency |
| Major acute risk | Hypoglycemia, including seizures |
Overview
Increlex treats growth failure in children aged two and older with severe primary IGF-1 deficiency, or growth-hormone gene deletion with neutralizing antibodies to GH. Primary IGF-1 deficiency means the problem is not simply inadequate GH secretion. The label excludes common secondary causes such as malnutrition, hypothyroidism or conventional GH deficiency. Diagnosis therefore determines whether replacing IGF-1 is biologically appropriate. Open growth plates and absence of prohibited malignancy history also matter. A low IGF-1 laboratory value alone does not establish this indication or justify use to improve strength in adults.
How it works
IGF-1 mediates many growth-promoting effects normally stimulated by GH. Mecasermin directly activates the IGF-1 receptor, supporting cell growth and uptake of glucose, amino acids and fatty acids. Direct administration bypasses the need for GH to generate adequate IGF-1, which can be useful in selected GH-resistant conditions. Its insulin-like metabolic actions also explain the possibility of severe hypoglycemia.
Who qualifies
The label covers severe primary IGF-1 deficiency or GH gene deletion with neutralizing GH antibodies. It specifically states that mecasermin is not a substitute for GH in approved GH indications and is not for secondary IGF-1 deficiency from malnutrition or hypothyroidism.
Supporting sources [1]
What treatment studies assess
Long-term clinical work evaluated growth in children with severe IGF-1 deficiency. Height velocity and attained growth are the relevant outcomes. This evidence does not establish improved athletic performance, adult muscle gain or lifespan extension.
Supporting sources [2]
Glucose and tissue-growth risks
Severe hypoglycemia can occur. Other important concerns include intracranial hypertension, enlarged tonsils or adenoids, slipped capital femoral epiphysis and progression of scoliosis. Serious allergic reactions are possible.
Supporting sources [1]
Growth plates and malignancy
Mecasermin is contraindicated for growth promotion after epiphyseal closure and in pediatric patients with malignant neoplasia or a history of malignancy. The label calls for discontinuation if evidence of malignant disease develops.
Supporting sources [1]
IGF-1 and GH are different treatments
GH acts upstream to stimulate IGF-1 production; mecasermin supplies IGF-1 directly. The correct treatment depends on where the growth pathway is impaired, so one hormone cannot be substituted for the other based solely on a desire to raise a laboratory value.
Supporting sources [1]
Reading this profile
Jurisdiction: United States — FDA-approved prescription medicine; indication and formulation restrictions apply.. Molecular class: Recombinant human insulin-like growth factor-1 protein.
This profile was written with AI-assisted research and checked against the linked sources. It has not been represented as a clinician’s review. Evidence summaries describe the cited studies and products; they do not establish that a separately purchased preparation is equivalent.
Sources & references
Follow the original material. Product labels define specific formulations and uses; trial registration describes a study and does not by itself establish benefit.
- DailyMed: Increlex current prescribing information ↗Regulatory source · Checked 2026-10-27
- Long-term treatment with recombinant insulin-like growth factor (IGF)-I in children with severe IGF-I deficiency due to growth hormone insensitivity. ↗Original research · Checked 2026-10-27