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Meet the

increlex-experts

Hear from healthcare professionals, patients, and caregivers as they share their expertise and experience on INCRELEX® (mecasermin).

Please see Indication and Important Safety Information below.

Dr. Backeljauw

Olive, a former
Increlex patient,
at age 10, and
her mother, Renee.

Meet the

increlex-experts

Hear from healthcare professionals, patients, and caregivers as they share their expertise and experience on INCRELEX® (mecasermin)

Please see Indication and Important Safety Information below.

Learn From the IncrelEXPERTS®

The IncrelEXPERTS® are a network of healthcare professionals, patients, and caregivers committed to sharing their knowledge about INCRELEX, the only treatment option for severe primary IGF-1 deficiency (SPIGFD). Based on real-world experience, you’ll learn how to recognize and diagnose SPIGFD, dose and titrate INCRELEX, and more. Explore these topics by watching the videos below.

Get to Know the IncrelEXPERTS®

Meet Philippe Backeljauw, MD, an IncrelEXPERT

  • Dr. Philippe Backeljauw is a Pediatric Endocrinologist at Cincinnati Children’s Medical Center who specializes in growth disorders
  • Recognized internationally as an expert in growth hormone resistance, Dr. Backeljauw is passionate about improving the process of diagnosis and treating patients with growth disorders
  • Years of spearheading research has led to hundreds of peer-reviewed manuscripts and abstracts, and contributed greatly to the treatment landscape of pediatric growth disorders

Meet Ron Rosenfeld, MD, an IncrelEXPERT

  • Dr. Rosenfeld is a professor and chair of pediatrics emeritus at Oregon Health & Science University, and a professor of pediatrics emeritus at Stanford University
  • Internationally renowned for his contributions to uncovering the role of growth factors and their receptors in growth disorders like SPIGFD
  • Dedication to research and understanding of the biology of growth hormone and growth factors has earned Dr. Rosenfeld numerous awards

Meet Lori Casnellie, RN, an IncrelEXPERT

  • Nurse Lori is currently the Care Manager, Division of Endocrinology at the Cincinnati Children’s Hospital Medical Center and has over 40 years of experience as a nurse in clinical practice

Disease Education

Ask an IncrelEXPERT: The Role of GH and IGF-1 to Promote Growth

Dr. Philippe Backeljauw explains the relationship between growth hormone (GH) and insulin-like growth factor (IGF-1) in statural growth.

Ask an IncrelEXPERT: Clinical Characteristics of Severe Primary IGF-1 Deficiency (SPIGFD)

Hear Dr. Ron Rosenfeld describe the phenotypic features of someone with SPIGFD.

Speak with our Nurse Specialist Team to learn more

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Diagnosis

Ask an IncrelEXPERT: Diagnostic Criteria for Severe Primary IGF-1 Deficiency (SPIGFD)

Do you know when to suspect SPIGFD? Here’s Dr. Philippe Backeljauw on the diagnostic criteria that may warrant a closer look, and why early treatment is so important.

Ask an IncrelEXPERT: Diagnosing Severe Primary IGF-1 Deficiency (SPIGFD)

Dr. Ron Rosenfeld discusses the diagnostic algorithm for SPIGFD.

Speak with our Nurse Specialist Team to learn more

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Dosing

Ask an IncrelEXPERT: 3 Steps to Dosing INCRELEX

Start, titrate, adjust. Watch Dr. Philippe Backeljauw break down the 3 steps to dosing INCRELEX.

Speak with our Nurse Specialist Team to learn more

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Tips for Nurses

Ask an IncrelEXPERT: Care Team

Nurse Lori provides pearls on how nurses can support the patient care team.

Ask and IncrelEXPERT: Counseling

Nurse Lori provides counseling tips for INCRELEX patients and their caregivers.

Speak with our Nurse Specialist Team to learn more

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INDICATION AND IMPORTANT SAFETY INFORMATION

INCRELEX® (mecasermin) is indicated for the treatment of growth failure in pediatric patients aged 2 years and older with severe primary IGF-1 deficiency* (IGFD), or with hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Limitations of use: INCRELEX is not a substitute to GH for approved GH indications. INCRELEX is not indicated for use in patients with secondary forms of IGFD, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

*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 GH.

IMPORTANT SAFETY INFORMATION

Contraindications

  • Hypersensitivity: to mecasermin (rhIGF-1), any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX. Allergic reactions have been reported, including anaphylaxis requiring hospitalization.
  • Intravenous Administration
  • Closed Epiphyses
  • Malignant Neoplasia in pediatric patients with malignant neoplasia or a history of malignancy.

Warnings and Precautions

  • Hypoglycemia: INCRELEX should be administered 20 minutes before or after a meal or snack and should not be administered when the meal or snack is omitted. Glucose monitoring and INCRELEX dose titration are recommended until a well-tolerated dose is established and as medically indicated.
  • Intracranial Hypertension: Funduscopic examination is recommended at the initiation of and periodically during the course of therapy.
  • Lymphoid Tissue Hypertrophy: Patients should have periodic examinations to rule out potential complications.
  • Slipped Capital Femoral Epiphysis: Carefully evaluate any pediatric patient with the onset of a limp or hip/knee pain during INCRELEX therapy.
  • Progression of Scoliosis: Patients with a history of scoliosis, treated with INCRELEX, should be monitored.
  • Malignant Neoplasia: There have been postmarketing reports of malignant neoplasia in pediatric patients who received treatment with INCRELEX. The tumors were observed more frequently in patients who received INCRELEX at higher than recommended doses or at doses that produced serum IGF-1 levels above the normal reference ranges for age and sex. Monitor all patients receiving INCRELEX carefully for development of neoplasms. If malignant neoplasia develops, discontinue INCRELEX treatment.
  • Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preserved Solution: Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol-preserved drugs. Use of INCRELEX in infants is not recommended.

Adverse Reactions

Common adverse reactions include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.

To report a suspected adverse event related to INCRELEX, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/Medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information for more information.

References

1. INCRELEX. Package insert. Eton Pharmaceuticals, Inc; 2023.

2. Backeljauw PF, Chernausek SD. Treatment of severe IGF-1 deficiency with recombinant human IGF-1 (mecasermin). Curr Med Lit Growth. 2009;2(3):69-95.

References

1. Backeljauw PF, Chernausek SD. Treatment of severe IGF-1 deficiency with recombinant human IGF-1 (mecasermin). Curr Med Lit Growth. 2009;2(3):69-95.

2. Cohen J, Blethen S, Kuntze J, et al. Managing the child with severe primary insulin-like growth factor-1 deficiency (IGFD): IGFD diagnosis and management. Drugs R D. 2014;14(1):25-29.

3. Kemp SF. Insulin-like growth factor-I deficiency in children with growth hormone insensitivity: current and future treatment options. BioDrugs. 2009;23(3):155-163.

4. 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 Manag. 2009;5(3):553-559.

5. Le Roith D, Scavo L, Butler A. What is the role of circulating IGF-I? Trends Endocrinol Metab. 2001;12(2):48-52.

6. Savage MO, Burren CP, Rosenfeld RG. The continuum of growth hormone IGF-I axis defects causing short stature: diagnostic and therapeutic challenges. Clin Endocrinol (Oxf). 2010;72(6):721-728.

7. INCRELEX. Package insert. Eton Pharmaceuticals, Inc; 2023.

References

1. Cohen J, Blethen S, Kuntze J, et al. Managing the child with severe primary insulin-like growth factor-1 deficiency (IGFD): IGFD diagnosis and management. Drugs R D. 2014;14(1):25-29.

2. INCRELEX. Package insert. Eton Pharmaceuticals, Inc; 2023.

3. 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.

4. Savage MO, Burren CP, Rosenfeld RG. The continuum of growth hormone IGF-I axis defects causing short stature: diagnostic and therapeutic challenges. Clin Endocrinol (Oxf). 2010;72(6):721-728.

5. 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 Manag. 2009;5(3):553-559.

6. Wit JM, Kiess W, Mullis P. Genetic evaluation of short stature. Best Pract Res Clin Endocrinol Metab. 2011;25(1):1-17.

7. Grimberg A, DiVall S, Polychronakos C, et al. Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency. Horm Res Paediatr. 2016;86:361-397.

References

1. INCRELEX. Package insert. Eton Pharmaceuticals, Inc; 2023.

2. Cohen J, Blethen S, Kuntze J, et al. Managing the child with severe primary insulin-like growth factor-1 deficiency (IGFD): IGFD diagnosis and management. Drugs R D. 2014;14(1):25-29.

3. Backeljauw PF, Chernausek SD. Treatment of severe IGF-1 deficiency with recombinant human IGF-1 (mecasermin). Curr Med Lit Growth. 2009;2(3):69-95.

4. Data on file. September 2018. Ipsen Biopharmaceuticals, Inc.