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Endocrinology

Increlex®

Increlex®

mecasermin

Description

Increlex® is a liquid formulation of recombinant human insulin-like growth factor-1(IGF-1).

Active substance

mecasermin, recombinant DNA-derived human IGF-1, Escherichia coli

Indications

Increlex® is indicated for:

the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (primary IGFD).

Severe primary IGFD is defined by:

- Height standard deviation score ≤ -3.0 and
- Basal IGF-1 levels below the 2.5th percentile for age and gender and
- GH sufficiency
- Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

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. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

Further information

Summary of product characteristics

Patient information leaflet

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