Increlex has been acquired by Eton on December 19, 2024

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Increlex has been acquired by Eton on December 19, 2024

This site is intended for US healthcare professionals only

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Staying on treatment with INCRELEX®

INCRELEX® dosing is dependent on many factors, such as tolerability and a child's weight and height. Regular weight monitoring throughout treatment is important for appropriate dosing.

Talk to your doctor about the growth expectations for your child while on INCRELEX® treatment.

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How to Inject Increlex

How to Inject Increlex

Watch this video to find out how to prepare and inject the correct dose of Increlex

Goal of Treatment

Goal of Treatment

Working with your child’s doctor to find the right treatment is very important in helping manage Severe Primary insulin-like growth factor-1 (IGF-1) Deficiency.

There is a window of time when your child is able to grow. Once your child enters the teen years, the potential to grow slows – and eventually stops – when the growth plates (epiphyses) close.

What to Expect

What to Expect with INCRELEX®

It is important to have realistic expectations of treatment with INCRELEX®, as changes to your child’s height may take time to be apparent.

GROWTH RATE WITH INCRELEX® OVER 8 YEARS3*

Growth rate chart

*Data comes from a clinical trial with 71 children with severe primary IGF-1 deficiency, Children aged > 2 years of age were eligible to enroll in the study. The mean age for these patients at baseline (before treatment) was: 7.8 years ± 4.5 years. The rate of growth pre-treatment (referred to as pretreatment height velocity) was available and is shown above for 58 patients. N is the number of patients evaluated for each year of therapy.

Results:

The average rate of growth (referred to as height velocity) increased by 8 cm per year in the first year from a baseline of 2.8 cm per year. The increase in height from year 1 compared to baseline was statistically significant (P < 0.0001).

The average rate of growth (referred to as height velocity) sustained by 5 cm per year in years 2 through 6 of treatment.

Patients experienced increased rate of height growth without increasing the rate of chronological bone age. Bone age is used to categorize the degree of skeletal maturation.

*Forty-nine subjects were included in an analysis of the effects of Increlex on the way your child’s bone changes in size and shape (referred as bone age). The mean ± SD change in chronological age was 4.9 ± 3.4 years and the mean ± SD change in bone age was 5.3 ± 3.4 years.

In clinical trials, INCRELEX® improved statural growth in patients diagnosed with Severe Primary IGFD

The response to INCRELEX® will vary from child to child.

You can help your doctor by regularly measuring your child’s height and monitoring their weight. Discuss with the doctor any changes to your child’s height and weight, as these will help to determine whether the dose of INCRELEX® needs to be changed.

What to Know About INCRELEX® Dose Adjustment

Regular weight monitoring and tolerability are critical for correct INCRELEX® dosing. Talk to your child’s doctor if their weight has changed so that they can determine the correct dose of INCRELEX®.

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.

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