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.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 0.04–0.12 mg/kg twice daily (weight-based, children) |
| Route | Subcutaneous |
| Frequency | Twice daily, shortly before or after (± 20 minutes) a meal or snack |
| Duration studied | Continuous while treating growth failure |
| Titration | Start 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 level | FDA Approved |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — Increlex, severe primary IGF-1 deficiencyFDA-approved label · FDA prescribing information | Children 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 hormone | 0.04–0.08 mg/kg to start; maximum 0.12 mg/kg | Subcutaneous only, rotating upper arm, thigh, buttock or abdomen; not intravenously | Twice daily, within 20 minutes of a meal or snack; the dose is withheld if the meal is skipped | Continuous | Treatment of growth failure | INCRELEX (mecasermin) injection (Eton Pharmaceuticals) — FDA prescribing information, DailyMed |
| FDA label — Increlex (earlier Ipsen labelling)FDA-approved label · FDA prescribing information | Same population as above | 0.04–0.08 mg/kg to start; maximum 0.12 mg/kg (the same dosing text as the Eton label) | Subcutaneous | Twice daily, within 20 minutes of a meal or snack | — | Treatment of growth failure | INCRELEX (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.