INCRELEX (Ipsen Pty Ltd)

INCRELEX (solution for injection) 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 less than or equal to ≤ -3.0 and
• Baseline height velocity less than the 25th percentile for bone age, based on two measurements over 12 months 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, hypopituitarism, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

IGF-1 and GH levels must be performed using validated assays with paediatric normal ranges.