Mecasermin [rDNA origin] Injection

INCRELEX® (mecasermin [rDNA origin] injection) contains human insulin-like growth factor-1 (rhIGF-1) produced by recombinant DNA technology. IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the product is identical to that of endogenous human IGF-1. The rhIGF-1 protein is synthesized in bacteria (E. coli) that have been modified by the addition of the gene for human IGF-1.

INCRELEX® is a sterile, aqueous, clear and colorless solution intended for subcutaneous injection. Each multi-dose vial of INCRELEX® contains 10 mg per mL mecasermin, 9 mg per mL benzyl alcohol, 5.84 mg per mL sodium chloride, 2 mg per mL polysorbate 20, and 0.05M acetate at a pH of approximately 5.4.

Severe Primary IGF-1 Deficiency (Primary IGFD)

INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the treatment of:

• growth failure in children with severe primary IGF-1 deficiency.
• growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Severe Primary IGF-1 deficiency (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).

Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. 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 INCRELEX® treatment.

Limitations of use

INCRELEX® is not a substitute to GH for approved GH indications.

Mecasermin is a man-made form of insulin-like growth factor-1 (IGF-1), a substance that is normally produced in the body. IGF-1 is important for the growth of bones and muscles.

Mecasermin is used to treat growth failure in children whose bodies do not make enough IGF-1.

Mecasermin may also be used for purposes not listed in this medication guide.

Your doctor or pharmacist can provide more information about mecasermin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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