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.

Healthcare Provider Resources

Referral Form

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

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®.

Letter of Medical Necessity

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

Letter of Appeal

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

Support for Your Patients

Eton Cares Program^®, Comprehensive, personalized support every step of the way

A prescription for INCRELEX® (mecasermin) automatically enrolls you in the Eton Cares Program® . Through the program, eligible, commercially insured patients can receive their medication for a co-pay of $0.*

What’s next?

Your doctor sent prescription to our speciality pharmacy Anovo.

Welcome Call from your Care Coordinator to verify prescription, offer support, and answer questions.
Insurance Verification to review and check coverage and benefits.
Financial Assistance Review to explore copay programs, financing, and other options.
Medication Delivery with instructions and specific product details.
Ongoing Support with pharmacists for refills, check-ins, alerts, and 24/7 help.

For questions or support

Please contact us at our speciality pharmacy Anovo® .

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

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.

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.
Closed Epiphyses
Malignant Neoplasia in pediatric patients with malignant neoplasia or a history of malignancy.

Warning 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: Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients receiving products indicated to treat growth failure and/or short stature, including INCRELEX. 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. It is unknown whether there is any relationship between Increlex therapy and new occurrences of neoplasia. 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.

*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.
Closed Epiphyses
Malignant Neoplasia in pediatric patients with malignant neoplasia or a history of malignancy.

Warning 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: Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients receiving products indicated to treat growth failure and/or short stature, including INCRELEX. 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. It is unknown whether there is any relationship between Increlex therapy and new occurrences of neoplasia. 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.

Please see full Prescribing Information for more information.

Healthcare Provider Resources

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