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Severe Primary IGF-1 Deficiency support and information

Learn about the ETON CARES® support program and download the patient information booklet on starting and staying on treatment with INCRELEX®. You can also find links to useful online resources to help you when you start your INCRELEX® treatment journey.

Online support

Online support and events

Eton Cares

Eton Cares provides copay and financial support. Patients who have been prescribed Increlex are automatically enrolled in Eton Cares.* Our reliable professionals are fully trained on Increlex and SPIGFD.

Copay Support

Eton Cares can help eligible, commercially insured patients get their medication for as little as $0 per month.*

Financial Support

Patients who do not have insurance and meet certain financial requirements may be eligible for additional financial support from a Patient Assistance Program.*

*Restrictions, limitations, and/or eligibility requirements may apply. For patients who are not eligible for copay support or who need additional financial assistance, Eton Cares can help connect you with alternative forms of medication coverage or provide referrals to other possible sources of funding.

INCRELEX® Information

INCRELEX® Information

Each Child is Unique – Patient Education Brochure

This brochure provides information about INCRELEX® for those who are starting their

IGF-1 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, and height, among other factors, such as tolerability.

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

Tips on How to Give an Increlex® Injection

Important things about administering Increlex

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What to expect when administering Increlex®

Some helpful information on the possible side effects of Increlex and ways to help manage them.

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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.

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.