Click here for updated information on Increlex® supply


  1. Increlex® [package insert]. Brisbane, CA: Tercica, Inc.; 2005.
  2. Rogol AD, Clark PA, Roemmich JN. Growth and pubertal development in children and adolescents: effects of diet and physical activity. Am J Clin Nutr. 2000;72(suppl):521S-8S.
  3. Rosenfeld RG, Cohen P. Disorders of growth hormone/insulin-like growth factor secretion and action. In: Sperling MA, ed. Pediatric Endocrinology. 3rd ed. Philadelphia, PA: Saunders Elsevier; 2008:281-8.
  4. Edouard, T, Grunenwald, S, Gennero, I, Salles, J P, Tauber, M. Prevalence of IGF1 deficiency in prepubertal children with isolated short stature. Eur J Endocrinol. 2009;161: 43-50.
  5. Marieb EN. Human Anatomy and Physiology. 5th ed. San Francisco, CA: Benjamin Cummings; 2001:609.
  6. Ranke, MB. Defining insulin-like growth factor-1 deficiency. Horm Res. 2006;65(suppl 1):9-14.
  7. Chernausek SD, Backelijauw PF, Frane J, Kuntze J, Underwood LE; for the GH Insensitivity Syndrome Collaborative Group. Long-term treatment with recombinant insulin-like growth factor (IGF)-1 in children with severe primary IGF-1 deficiency due to growth hormone insensitivity. J Clin Endocrinol Metab. 2007;92(3):902-910.
  8. Bakker B, Frane J, Anhalt H, Lippe B, Rosenfeld RG. Height velocity targets from the national cooperative growth study for first-year growth hormone responses in short children. J Clin Endocrinol Metab. 2008;93:352-357.
  9. Fintini D, Brufani C, Cappa M. Profile of mecasermin for the long-term treatment of growth failure in children and adolescents with severe Primary IGF-1 deficiency. Ther Clin Risk Manage. 2009; 5(3):553-559.
  10. Ranke MB. Diagnosis of growth hormone deficiency and growth hormone stimulation tests. In: Ranke MB, ed. Diagnostics of Endocrine Function in Children and Adolescents. Basel: S. Karger AG; 2003: 107-128.
  11. Ranke MB, Feldt-Rasmussen U, Bang P, et al. How should IGF-I be measured? A consensus statement. Horm Res. 2001;55(suppl 2):106-109.
  12. Moseley CT, Phillips, JA. Pituitary gene mutations and the growth hormone pathway. Semin Reprod Med. 2000; 18(1):21-29. Accessed by Medscape.
  13. Rosenfeld, RG. Pharmacogenomics of pharmacoproteonics in the evaluation and management of short stature. Eur J Endocrinol. 2007; 157(suppl):S27-S31.
  14. Rosenfeld RG. Molecular mechanisms of IGF-1 deficiency. Horm Res. 2006; 65 (suppl 1):15-20.
  15. Rosenfeld RG. Biochemical diagnostic strategies in the evaluation of short stature: the diagnosis of insulin-like growth factor deficiency. Horm Res. 1996; 46:170-173.
  16. Rosenfeld RG, Rosenbloom AL, Guevara-Aguirre J. Growth hormone (GH) insensitivity due to primary GH receptor deficiency. Endocr Rev. 1994; 15 (3):369-390.
  17. Bercu, B. Treatment, dosing, and follow-up of children with primary and secondary IGFD. Rev Endocrinol. July 2008: 38-40.
  18. Park, P, Cohen, P. Insulin-like growth factor 1 (IGF-1) measurements in growth hormone (GH) therapy of idiopathic short stature (ISS). Growth Horm IGF Res. 2005;15 (supplA):S13-20.
  19. Clayton PE, Ayoola O, Whatmore AJ. Patient selection for IGF-I therapy. Horm Res. 2006;65(suppl 1):28-34.
  20. Rosenthal S, Cohen P, Clayton P, et al. Part II: Defining and managing growth hormone treatment failure. Pediatr Endocrinol Rev. 2007; 4 (suppl 2): 257-268.
  21. Rosenthal, S, Cohen P, Clayton, P Backeljauw P, Bang P, Ten S. Treatment perspectives in idiopathic short stature with a focus on IGF-1 deficiency. Pediatr Endocrinol Rev. 2007; 4 (suppl 2):252-271.
  22. Cohen P, Rogol AD, Deal CL, et al. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008;93(11):4210-4217.
  23. Wit JM, Clayton PE, Rogol AD, Savage MO, Saenger PH, Cohen P. Idiopathic short stature: definition, epidemiology, and diagnostic evaluation. Growth Horm IGF Res. 2008;18(2):89-110.
  24. Savage, MO, Blair, JC, Jorge, AJ, Street, ME, Ranke, MB, Camacho-Hübner C. IGFs and IGFBPs in GH insensitivity. In: Cianfarani S, Clemmons DR, Savage MO, eds. IGF-I and IGF Binding Proteins. Basic Research and Clinical Management: Endocrine Development. Basel: S. Karger AG; 2005:100-106.
  25. American Association for Clinical Chemistry. IGF-1: The Test. LabTestsOnline Web site. Accessed August 9, 2010.
  26. American Association for Clinical Chemistry. Growth Hormone: Test Sample. LabTestsOnline Web site. Accessed August 9, 2010.
  27. Growth Hormone Binding Protein. Healthcare Magic Web site. Accessed August 11, 2010.
  28. Baxter RC, Svejkar M, Khosravi MJ, et al. Measurement of the acid-labile subunit of the insulin-like growth factor binding protein complex in human serum: a comparison of four immunoassays. J Endocrinol. 2000;165(2):271-279.
  29. Reiner B, Bowlby D, Kuntze J, Hertz J, Frane JW, Blethen S. Increlex therapy in children who were treatment-naïve or previously treated with growth-promoting therapy: first-year results from the Increlex Growth Forum Database (IGFD) registry. Poster presented at: ENDO 2010: 92nd Annual Meeting and Expo; June 20, 2010; San Diego, CA.
  30. Backeljauw PF, Underwood LE. Therapy for 6.5-7.5 years with recombinant insulin-like growth factor I in children with growth hormone insensitivity syndrome: a clinical research center study. J Clin Endocrinol Metab. 2001; 86(4):1504-1510.
  31. IGFD Registry: a patient registry for monitoring long-term safety and efficacy of Increlex. ClinicalTrial Web site. Accessed August, 8, 2010.
  32. Melmed S, Jameson JL. Disorders of anterior pituitary and hypothalamus. In: Fauci AS, Braunwald E, Kasper DL, Hauser SL, Longo DL, Jameson LJ, Loscalzo J, eds. Harrison's Principles of Internal Medicine. Vol 2.16th ed. New York, NY: McGraw Hill; 2076-2097.
  33. Rosenfeld RG, Buckway C, Selva K, Pratt KL, Guevara-Aguirre J. Insulin-like growth factor (IGF) parameters and tools for efficacy: the IGF-I generation test in children. Horm Res. 2004;62(suppl 1):37-43.
  34. Data on file. Brisbane, CA: Tercica, Inc.; 2010.
  35. Increlex® [Patient package insert]. Brisbane, CA: Tercica, Inc.; 2005.

Indication and Important Safety Information

INCRELEX® (mecasermin [rDNA origin] injection) is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency, or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH). Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. They are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.

INCRELEX is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.

Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.

INCRELEX is contraindicated in the presence of active or suspected malignancy, and therapy should be discontinued if evidence of malignancy develops. 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 and Adverse Reactions]. Intravenous administration of INCRELEX is contraindicated. INCRELEX should not be used for growth promotion in patients with closed epiphyses.

INCRELEX has insulin-like hypoglycemic effects and should be administered 20 minutes before or after a meal or snack. Hypersensitivity and allergic reactions have been reported, including a low number of cases indicative of anaphylaxis requiring hospitalization. Intracranial hypertension has occurred in patients treated with INCRELEX. Funduscopic examination is recommended at the initiation of and periodically during the course of therapy. Patients should have periodic examinations to rule out potential complications from tonsillar/adenoidal hypertrophy and receive appropriate treatment if necessary. Children with onset of limp or hip/knee pain should be evaluated for possible slipped capital femoral epiphysis. Monitor any child with scoliosis for progression of the spine curve.

In clinical studies of 71 pediatric subjects with severe Primary IGFD representing 274 patient-years of treatment, no subjects discontinued due to adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy with INCRELEX. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of INCRELEX. Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of INCRELEX treatment. INCRELEX treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088.

For Patient Product Information, click here.
For Full Prescribing Information, click here.