Mecasermin (Increlex)

Covers Increlex (mecasermin) only for pediatric severe primary IGF‑1 deficiency and for children with GH gene deletion who develop neutralizing GH antibodies, excluding other off‑label/compendial uses. Initial approval requires height SDS ≤ −3.0, basal IGF‑1 below the lab reference, normal/increased GH, and prescription by or consultation with a pediatric endocrinologist; reauthorization (approved up to 12 months) requires ≥1 year on therapy, ≥4 cm height gain in the most recent year, open epiphyses, and dosing titration from 0.04–0.08 mg/kg SC twice daily to a 0.12 mg/kg twice‑daily maximum.

"Approval duration is limited to 12 months per authorization."

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