Introducing Increlex

The First and Only

• The FIRST rhIGF-1 (recombinant human insulin-like growth factor-1) therapy approved in the United States
• The ONLY isolated IGF-1 replacement therapy indicated specifically for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD)¹

For a Distinct Disease State

Severe primary IGF-1 deficiency (Primary IGFD) is a distinct diagnosis of short stature and is defined by:¹

• Height standard deviation score ≤ -3.0
• Basal IGF-1 standard deviation score ≤ -3.0
• Normal or elevated growth hormone¹

It is believed that approximately 6,000 children in the US
have severe primary IGF-1 deficiency (Primary IGFD)²

• Severe Primary IGFD causes are rooted in the IGF-1 expression and production pathway.
• Disease state includes patients with mutations in the growth hormone receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects.
  • Patients are not growth hormone deficient, and therefore, cannot be expected to respond adequately to exogenous GH treatment.
• Reduced levels of endogenous IGF-1 can be detected by an IGF-1 assay.

Increlex is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as growth hormone deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

Thyroid and nutritional deficiencies should be corrected before initiating Increlex treatment.

Increlex is not a substitute for growth hormone treatment.