• Treatment of growth failure in children with severe primary insulin-like growth factor-1 (IGF-1) deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Primary IGFD (insulin-like growth factor deficiency):

• Diagnosis of primary IGF-1 deficiency
  

GH Gene Deletion with Growth Hormone Neutralizing Antibodies:

• Documentation of growth hormone gene deletion and GH neutralizing antibodies

Indications for Continuation of Increlex in Children or Adolescents:

Documentation of adequate compliance with therapy, AND any of the following:

• Growth rate greater than 2.5 cm per year

OR

• Measured mid parental height has not been reached

OR

• Growth rate has increased by 50% over baseline in the first year of therapy

• Patients with closed epiphyses
• Patients with active or suspected neoplasm
• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature.

• Severe Primary IGFD is defined by:
  • height standard deviation score less than or equal to -3.0 and
  • basal IGF-1 standard deviation score less than or equal to -3.0 and
  • normal or elevated growth hormone (GH).
• 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.
• Increlex is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating treatment.
• Increlex is not a substitute for GH treatment.
• Failure to increase height velocity during the first year of therapy by at least 2 cm/year suggests the need for assessment of compliance and evaluation of other causes of growth failure, such as hypothyroidism, under-nutrition, and advanced bone age.
• Increlex should not be used in children less than 2 years old.
• The following are contraindications to Increlex use: active or suspected neoplasia, known hypersensitivity, intravenous administration and close epiphyses.