Mecasermin

Insulin-like growth factor-1 (IGF-1) is a key hormonal mediator on statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver, and other tissues, and stimulates the synthesis/secretion of IGF-1.

• INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. ( 1 ) Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.

• Known Hypersensitivity to mecasermin ( 4 ) Closed Epiphyses ( 4 ) Malignant Neoplasia ( 4 ) Known Hypersensitivity INCRELEX should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX [see Warnings and Precautions (5.2) and Adverse Reactions (6) ]. Closed Epiphyses INCRELEX should not be used for growth promotion in patients with closed epiphyses.contraindicated

INCRELEX should be administered subcutaneously. ( 2.2 ) Injection sites should be rotated to avoid lipohypertrophy. ( 2.2 ) Recommended starting dosage: 0.04 mg/kg to 0.08 mg/kg twice daily. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily. ( 2.1 ) 2.1 Recommended Dosage Treatment with INCRELEX should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with severe primary IGF-1 deficiency or with growth hormone gene deletion and who have developed neutralizing antibodies to growth hormone. The dosage of INCRELEX should be individualized for each patient. The recommended starting dose of INCRELEX is 0.04 mg/kg to 0.08 mg/kg of body weight twice daily by subcutaneous injection. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg of body weight per dose, to the maximum dose of 0.12 mg/kg of body weight given twice daily [see Warnings and Precautions (5.1 and 5.7) ]. Preprandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue, and glucose monitoring should also occur at the time of event if possible. If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced. INCRELEX should be administered shortly before or after (± 20 minutes) a meal or snack.

Hypoglycemia: Severe hypoglycemia leading to hypoglycemic seizures has been observed with INCRELEX treatment. Administer INCRELEX shortly before or after a meal or snack, because it has insulin-like hypoglycemic effects. ( 5.1 ) Hypersensitivity and Allergic Reactions, including Anaphylaxis: A low number of cases indicative of anaphylaxis requiring hospitalization have been reported. Parents and patients should be informed that such reactions are possible and that if a systemic allergic reaction occurs, treatment should be interrupted and prompt medical attention should be sought. ( 5.2 ) Intracranial Hypertension : Funduscopic examination is recommended at the initiation and periodically during the course of INCRELEX therapy. ( 5.3 ) Lymphoid Tissue Hypertrophy (tonsillar/adenoidal hypertrophy): Patients should have periodic examinations to rule out potential complications and receive appropriate treatment if necessary. ( 5.4 ) Slipped Capital Femoral Epiphysis (SCFE): Evaluate any child with onset of a limp or hip/knee pain for possible SCFE and osteonecrosis. ( 5.5 ) Progression of Scoliosis: Monitor any child with scoliosis for progression of the spine curve. ( 5.6 ) Malignant Neoplasia: Several cases of malignant neoplasia have been observed in pediatric patients treated with INCRELEX. Therapy should be discontinued if evidence of malignant neoplasia develops and appropriate expert medical care sought.

The following serious adverse reactions are described below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1) ]. Hypersensitivity and Allergic Reactions, including Anaphylaxis [see Warnings and Precautions (5.2) ] Intracranial hypertension (IH) [see Warnings and Precautions (5.3) ] Tonsillar and Adenoidal Hypertrophy and related complications [see Warnings and Precautions (5.4) ] Slipped Capital Femoral Epiphysis [see Warnings and Precautions (5.5) ] Progression of Preexisting Scoliosis [see Warnings and Precautions (5.6) ] Malignant Neoplasia [see Warnings and Precautions (5.7) ] Benzyl Alcohol [see Warnings and Precautions (5.8) ] Common INCRELEX-related adverse reactions in clinical trials include: hypoglycemia, local and systemic hypersensitivity, tonsillar hypertrophy ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies of 71 subjects with Primary IGFD treated for a mean duration of 3.9 years and representing 274 subject-years, no subjects withdrew from any clinical study because of adverse reactions. Adverse reactions to INCRELEX treatment that occurred in 5% or more of these study participants are listed below by organ class.

Pediatric Use: Safety and effectiveness has not been established in children less than 2 years of age. ( 8.4 ) 8.1 Pregnancy Risk Summary There are no available data on INCRELEX use in pregnant women. Exposure to INCRELEX during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure. In animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration of INCRELEX to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times the maximum recommended human dose (MRHD) of 0.24 mg/kg/day based on body surface area (BSA), respectively (see Data ) . The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Studies to assess embryo-fetal toxicity evaluated the effects of INCRELEX during organogenesis in Sprague Dawley rats given 1, 4, and 16 mg/kg/day and in New Zealand White rabbits given 0.125, 0.5, and 2 mg/kg/day, administered intravenously. There were no observed embryo-fetal developmental abnormalities in rats given up to 16 mg/kg/day (11 times the MRHD based on BSA comparison).

Metabolism

Absorption – The absolute bioavailability of rhIGF-1 after subcutaneous administration in healthy subjects is estimated to be close to 100%. However, the absolute bioavailability of INCRELEX given subcutaneously to subjects with primary insulin-like growth factor-1 deficiency (Primary IGFD) has not been determined.

Treatment of acute overdose should be directed at reversing hypoglycemia. Oral glucose or food should be consumed. If the overdose results in loss of consciousness, intravenous glucose or parenteral glucagon may be required to reverse the hypoglycemic effects. A small number of overdose cases have been reported in the post-marketing experience. In one case of acute overdose, a 3-year old patient experienced hypoglycemia after receiving one 4 mg dose of INCRELEX (a 10-fold increase beyond the prescribed dose). The event resolved following treatment with IV glucose. Long term overdosage with INCRELEX may result in signs and symptoms of acromegaly.

• Aug 30, 2005BLABLA021839Ipsen Inc

1. 1Off Label Use13016%
2. 2Headache688.4%
3. 3Hypoglycaemia627.7%
4. 4Vomiting445.5%
5. 5Injection Site Pain415.1%
6. 6Drug Dose Omission405.0%
7. 7Pyrexia364.5%
8. 8Tonsillar Hypertrophy364.5%
9. 9Blood Glucose Decreased354.3%
10. 10Fatigue344.2%
11. 11Product Dose Omission Issue303.7%
12. 12Decreased Appetite273.4%
13. 13Injection Site Pruritus253.1%
14. 14Injection Site Erythema243.0%
15. 15Drug Ineffective222.7%

The 10 most recently updated of 37 ClinicalTrials.gov registrations naming Mecasermin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
  Recruiting · Phase 2 · Interventional · 338 enrolled · OHB Neonatology Ltd.
  NCT03253263updated 2026-06-11
• Increlex Treatment of Children With Chronic Liver Disease and Short Stature
  Withdrawn · Interventional · 0 enrolled · University of California, Los Angeles
  NCT01314508updated 2026-04-14
• User Testing of an End of Life Medication Support Intervention for Lay Carers (Palliate).
  Completed · Interventional · 30 enrolled · Imperial College London
  NCT06526637updated 2026-03-27
• Biomarkers of Response to SEEG Thermocoagulation
  Not yet recruiting · Interventional · 45 enrolled · Assistance Publique Hopitaux De Marseille
  NCT07399327updated 2026-02-10
• Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
  Recruiting · Observational · 500 enrolled · Esteve Pharmaceuticals, S.A.
  NCT00903110updated 2026-02-06
• Personalized Care for Prenatal Stress Reduction & Prevention of Preterm Birth (PTB) Disparities
  Not yet recruiting · Interventional · 1,228 enrolled · University of North Carolina, Chapel Hill
  NCT06915428updated 2026-01-21
• Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis
  Recruiting · Observational · 76 enrolled · University Hospital, Montpellier
  NCT06602869updated 2025-07-10
• IGF-1 Treatment for Individuals With Short Stature Due to PAPP-A2 Deficiency
  Completed · Phase 1 · Phase 2 · Interventional · 7 enrolled · Children's Hospital Medical Center, Cincinnati
  NCT02636270updated 2024-02-28
• A Pilot Treatment Study of Insulin-Like Growth Factor-1 (IGF-1) in Autism Spectrum Disorder
  Terminated · Phase 2 · Interventional · 3 enrolled · Icahn School of Medicine at Mount Sinai
  NCT01970345updated 2024-02-08
• Gender Differences in Renal Functioning and Disease
  Completed · Observational · 98 enrolled · Centre Hospitalier Universitaire Vaudois
  NCT04085094updated 2023-09-13

Frequently asked questions

How does Mecasermin work?

Insulin-like growth factor-1 (IGF-1) is a key hormonal mediator on statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver, and other tissues, and stimulates the synthesis/secretion of IGF-1.

What is Mecasermin used for?

According to FDA labeling, Mecasermin carries indications including: INCRELEX (mecasermin) injection is indicated for the treatment of growth failure in pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. ( 1 ) Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Mecasermin?

Mecasermin is classified as Somatropin and somatropin agonists.

What are the brand names for Mecasermin?

Mecasermin is marketed under brand names including Increlex.

What are the contraindications for Mecasermin?

Mecasermin labeling lists contraindications including: Known Hypersensitivity to mecasermin ( 4 ) Closed Epiphyses ( 4 ) Malignant Neoplasia ( 4 ) Known Hypersensitivity INCRELEX should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX [see Warnings and Precautions (5.2) and Adverse Reactions (6) ]. Closed Epiphyses INCRELEX should not be used for growth promotion in patients with closed epiphyses.. Always consult the full prescribing information and a clinician.