Indications for INCRELEX:
Growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or in those with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.
Limitations of Use:
Not a substitute to GH for approved GH indications.
Closed epiphyses: not recommended.
Administer before or after (+/–20 minutes) a meal/snack; rotate inj sites (upper arm, thigh, buttock or abdomen). <2yrs: not established. Individualized. ≥2yrs: initially 0.04 to 0.08mg/kg SC twice daily; may increase after 1 week by 0.04mg/kg per dose; max 0.12mg/kg twice daily.
Growth promotion in patients with closed epiphyses. Malignant neoplasia or history of malignancy. IV administration.
Not for secondary forms of IGF-1 deficiency. Correct thyroid and nutritional deficiences before treatment. Measure preprandial glucose level before treatment and monitor until a tolerated dose is established. Reduce dose if hypoglycemia occurs despite adequate food intake with therapy. Monitor for lymphoid tissue hypertrophy complications. Monitor for malignant neoplasms; discontinue if develops. Do funduscopic exam for intracranial hypertension at the start of therapy, then periodically. Evaluate any child with onset of limp or hip/knee pain for possible slipped capital femoral epiphysis. Monitor for progression of scoliosis. Infants: avoid. Pregnancy. Nursing mothers.
Recombinant human insulin-like growth factor-1 (rhIGF-1).
Hypoglycemia, local/systemic hypersensitivity (including anaphylaxis), lymphoid tissue hypertrophy (eg, tonsillar and adenoidal hypertrophy); intracranial hypertension.
Generic Drug Availability:
Multidose vial (40mg/vial)—1