Increlex is used to treat children with a form of growth failure called severe primary IGF-1 deficiency (IGFD), which can cause permanent short stature. The supply interruption of Increlex occurred in
“We are very pleased that the resupply of Increlex will be taking place in the U.S., as we have been working in very close collaboration with the
The active substance in Increlex® is a recombinant insulin-like growth factor of human origin (IGF-1). IGF-1 is the direct hormonal mediator of stature and bone growth and must be present for normal growth of bones and cartilage in children. In severe primary IGF-1 deficiency, children’s serum IGF-1 levels are low despite the presence of normal or elevated growth hormone (GH) levels. If the IGF-1 is not present in sufficient quantities, the child will not reach a normal stature.
Increlex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (IGFD), or with growth hormone (GH) gene deletion, who have developed neutralizing antibodies to GH. Severe primary IGFD is defined by height standard deviation score = -3.0 and basal IGF-1 standard deviation score = -3.0 and normal or elevated growth hormone (GH).
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 Increlex treatment. Increlex is not a substitute to GH for approved GH indications. Increlex has not been studied in children < 2 years of age.
Important Safety Information
Warnings and Precautions:
Common adverse reactions include: hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
Please see the full Prescribing Information for Increlex available at http://increlex.com/pdf/hcp-full-prescribing-information.pdf
Patient Information for Increlex available at http://increlex.com/pdf/patient-full-prescribing-information.pdf
Forward Looking Statements
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