Increlex
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Increlex®▼ - mecasermin

Increlex<sup>®</sup> - 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

Increlex® is indicated for:

  • The long-term treatment of growth failure in children and adolescents from 2 to 18 years 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.

▼Increlex is subject to additional monitoring as a condition of its marketing authorisation in Europe. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Reporting forms and information can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to the Ipsen Medical Information department on 01753 627777 or medical.information.uk@ipsen.com.