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INCRELEX® Healthcare Provider Resources

This section provides various INCRELEX® (mecasermin) resources for healthcare professionals (HCPs) to use in daily practice in determining diagnosis and treatment of severe primary insulin-like growth factor-1 deficiency (SPIGFD).

Please see Indication and Important Safety Information below.

Olive, a former
Increlex patient,
at age 10.

INCRELEX® Healthcare Provider Resources

This section provides various resources for healthcare professionals (HCPs) to use in daily practice in determining diagnosis and treatment of severe primary insulin-like growth factor-1 deficiency (SPIGFD).

Please see Indication and Important Safety Information below.

HCP Resources

Healthcare Provider Resources

INCRELEX® Referral Form

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INCRELEX® Titration Flashcard

The Titration Flashcard offers an overview of the 3 simple steps to individualized dosing, including the periodic assessment of the patient's weight, tolerability, and laboratory parameters.

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INCRELEX® Dosing Guide Flashcard

The Dosing Guide can help determine the volume of medication necessary for each patient to receive their appropriate individualized dose of INCRELEX®.

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Letter of Medical Necessity

Use this template to develop a letter of medical necessity explaining why your patient requires INCRELEX®.

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Letter of Appeal


Use this template to appeal the denial of benefits for your patient's use of INCRELEX®.

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Support for Patients

Support for Your Patients

INCRELEX® Patient Education Brochure

This brochure can help parents understand severe primary IGF-1 deficiency and treatment with INCRELEX®. It includes important safety information, what to know about dosing, a growth progress chart, a Doctor Discussion Guide for questions that may arise, and details about the Eton Cares support program.

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Eton Cares

Eton Cares is a comprehensive support program designed to help your patients get access to the medications and services that they need. The program is designed to simplify the process of applying for and getting coverage for INCRELEX® as well as to serve as a central point of contact between you, your patients’ parents or guardians, insurance companies, and specialty pharmacies.

Patients prescribed INCRELEX® are automatically enrolled in Eton Cares. Through the program, eligible, commercially insured patients can receive their medication for a co-pay of $0.*

Patients also have access to a dedicated team of:

Insurance specialists

  • Assist with the insurance process, such as prior authorization and appeal support
  • Investigate insurance coverage for your medication
  • Help with co-pay assistance and other financial assistance options

Pharmacists

  • Answers all the questions needed about your medication
  • Provides refill reminders and ensures your medication arrives on time
  • 24/7/365 support

Nurse ambassadors

  • Check in with you to answer any questions you have about INCRELEX®

*Restrictions, limitations, and/or eligibility requirements apply.

Call Anovo® Specialty Pharmacy hotline to ask questions about INCRELEX® at 1-833-343-2500.

Available Monday through Friday, 8 AM - 5 PM CT.

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.