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INCRELEX® Healthcare Provider Resources

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

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HCP Resources

Healthcare Provider Resources

INCRELEX® Health Care Coverage Information Resource

The INCRELEX® Health Care Coverage Resource may be helpful to understand what types of information health plans need to evaluate coverage of INCRELEX®. It also includes a reminder of the INCRELEX® indication and important safety information and why it is important to measure Insulin-like growth factor-1 (IGF-1) levels early in your appropriate patients.

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INCRELEX® Unit Calculation Guide

INCRELEX® Unit Calculation Guide may be used to determine the volume of medication to be administered to achieve the prescribed dose of INCRELEX®. The guide overviews the recommended starting dosage of INCRELEX® and how it should be individualized for each patient.

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INCRELEX® Titration Flashcard

INCRELEX® dosing should be individualized based on the periodic assessment of each patient’s weight, tolerability, and laboratory parameters.1 This flashcard gives a brief overview of how to adjust INCRELEX® dosing based on three simple steps.

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Support for Patients

Support for Your Patients

IPSEN CARES®

IPSEN 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.

The IPSEN CARES® program helps your patients by providing the forms that will help your staff get eligible patients enrolled and authorized, provides information on copay programs and other financial assistance, and helps coordinate home delivery and home injection services. For patient eligibility criteria and terms and conditions please visit the IPSEN CARES® website.

INCRELEX® Patient Education Brochure

This brochure provides information about INCRELEX® for those who are starting their SPIGFD treatment journey. It provides details of how INCRELEX® works to help children grow and how their treatment needs to be determined based on their age, weight, height and tolerability.

The brochure provides a practical means for parents to record their child’s growth progress, and space to note any questions that they may wish to ask during follow-up appointments. Important safety information about INCRELEX® treatment is included, as is information about the IPSEN CARES® support program.

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Important Safety Information and Indication

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.

Indication

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.1

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.1

*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.

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INCRELEX® is a registered trademark of Ipsen Biopharmaceuticals, Inc. IPSEN CARES is a registered trademark of Ipsen S.A

© 2021 Ipsen Biopharmaceuticals, Inc. All rights reserved. 04/2021 INC-US-001014