Mecasermin dosage in published studies and labels

These are the doses used for Mecasermin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources:

Studied regimens and sources

Mecasermin has an FDA-approved human dosage as Increlex, for growth failure in children aged 2 and older with severe primary IGF-1 deficiency, or with growth hormone gene deletion and neutralising antibodies to growth hormone. The label starts at 0.04–0.08 mg/kg twice daily by subcutaneous injection and allows increases of 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Each dose is given within 20 minutes before or after a meal or snack because mecasermin can cause hypoglycaemia.

FDA Approved
Dosage evidence summary for Mecasermin
Human dosing establishedYes
Studied dose range0.04–0.12 mg/kg twice daily (weight-based, children)
RouteSubcutaneous
FrequencyTwice daily, shortly before or after (± 20 minutes) a meal or snack
Duration studiedContinuous while treating growth failure
TitrationStart at 0.04–0.08 mg/kg twice daily; if well tolerated for at least one week, increase by 0.04 mg/kg per dose to a maximum of 0.12 mg/kg twice daily. Reduce the dose if hypoglycaemia occurs despite adequate food intake.
Evidence levelFDA Approved
Last reviewed2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Mecasermin, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
FDA label — Increlex, severe primary IGF-1 deficiencyFDA-approved label · FDA prescribing informationChildren aged 2 years and older with severe primary IGF-1 deficiency (height and basal IGF-1 SDS of –3.0 or lower with normal or raised growth hormone), or with growth hormone gene deletion and neutralising antibodies to growth hormone0.04–0.08 mg/kg to start; maximum 0.12 mg/kgSubcutaneous only, rotating upper arm, thigh, buttock or abdomen; not intravenouslyTwice daily, within 20 minutes of a meal or snack; the dose is withheld if the meal is skippedContinuousTreatment of growth failureINCRELEX (mecasermin) injection (Eton Pharmaceuticals) — FDA prescribing information, DailyMed
FDA label — Increlex (earlier Ipsen labelling)FDA-approved label · FDA prescribing informationSame population as above0.04–0.08 mg/kg to start; maximum 0.12 mg/kg (the same dosing text as the Eton label)SubcutaneousTwice daily, within 20 minutes of a meal or snack—Treatment of growth failureINCRELEX (mecasermin) injection (Ipsen) — FDA prescribing information, DailyMed

Where sources disagree

  • The label warns that severe hypoglycaemia leading to seizures has occurred, which is why each dose is tied to a meal and withheld if the meal is skipped. It also lists malignant neoplasia seen in treated children, intracranial hypertension, tonsillar and adenoidal enlargement, slipped capital femoral epiphysis and progression of scoliosis.
  • Increlex is preserved with benzyl alcohol, and the label does not recommend it in infants. It is not a substitute for growth hormone in approved growth hormone indications, and it is not indicated for secondary forms of IGF-1 deficiency.
  • Mecasermin is recombinant human IGF-1, the same medicine described on the IGF-1 profile. It is not IGF-1 LR3 or IGF-1 DES, which are engineered analogues with no human dosing evidence of their own. It is supplied as a ready-made 10 mg/mL solution in a 40 mg/4 mL multiple-dose vial.