Texas Health and Human Services Commission
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Criteria for Outpatient Use Guidelines

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Mecasermin (Increlex®)

[Developed, December 2006; Revised, May 2007; May 2010; June 2010]

Information on indications for use or diagnosis is assumed to be unavailable. All criteria may be applied retrospectively; prospective application is indicated with [*].

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1.* Dosage

Mecasermin (Increlex®) is the recombinant DNA form of human insulin-like growth factor-1 (rhIGF-1).  In normal circulation, over 98% of rhIGF-1 is available in bound form to IGFBP-3, which allows IGF-1 to remain inactive until released to target tissues.  This reduces the potential for adverse events associated with free levels of IGF-1.  In patients with growth hormone insensitivity syndrome, the serum half-life of unbound IGF-1 is decreased, as these patients have lower rhIGFBP-3 concentrations.  Patients with IGF-1 gene deletion have normal levels of rhIGFBP-3.  Mecasermin is FDA-approved for use in treating growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.  Mecasermin is approved for use in children 2 years of age and older up to 22 years of age; mecasermin is not FDA-approved for use in adults.  The recommended dosage for mecasermin is 120 mcg/kg twice daily subcutaneously (total: 240 mcg/kg/day). Patient profiles containing prescriptions for doses exceeding these recommendations will be reviewed.

Mecasermin should be administered with food or a snack as IGF-1 decreases hepatic glucose production and increase peripheral glucose utilization and may induce hypoglycemia.  Mecasermin administration should be withheld in patients unable or unwilling to eat a meal prior to mecasermin dosing.

2. Duration of Therapy

Five clinical studies evaluated mecasermin use in 71 pediatric patients with severe primary IGF-1 deficiency (one double-blind, placebo-controlled trial and four open-label trials).  Results revealed 61 patients completed at least one year of treatment and 13 patients received mecasermin therapy for 8 years.   The mean change in height velocity significantly increased from baseline in mecasermin-treated patients for treatment years 1 through 6.  However, a maximum treatment duration has not been defined for mecasermin.

References

  1. AHFS Drug Information 2010 [book online].  Jackson, WY:  Teton Data Systems, Version 6.7.1, 2009.  Based on:  McEvoy GK, editor.  AHFS drug information 2010.  Bethesda (MD):  American Society of Health-System Pharmacists; 2010.  Stat!Ref Electronic Medical Library.
  2. Mecasermin (Drug Evaluation). In: DRUGDEX® System (electronic version). Thomson Reuters (Healthcare) Inc., Greenwood Village, Colorado, USA. Available at: http://www.thomsonhc.com.libproxy.uthscsa.edu.   Accessed May 12th, 2010.
  3. Mecasermin [rDnA origin] injection (Increlex®) package insert.  Tercica, Inc., August 2007.
  4. Chernausek SD, Backeljauw PF, Frane J, et al for the GH Insensitivity Syndrome Collaborative Group.  Long-term treatment with recombinant insulin-like growth factor (IGF)-I in children with severe IGF-I deficiency due to growth hormone insensitivity. J Clin Endocrinol Metab. 2007;92(3):902-10.
  5. Bright GM, Mendoza JR, Rosenfeld RG.  Recombinant human insulin-like growth factor-1 treatment: ready for primetime.  Endocrinol Metab Clin N Am.  2009;38:625–638.
  6. Drug Facts and Comparisons.  Clin-eguide [database online].  St. Louis, MO:  Wolters Kluwer Health, Inc; 2010.  Available at:  http://clineguide.com.  Accessed June 4th, 2010.
  7. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc; 2010. Available at: http://www.clinicalpharmacology.com. Accessed June 4th, 2010.

 

Prepared by: Drug Information Service, The University of Texas Health Science Center at San Antonio, and the College of Pharmacy, The University of Texas at Austin.