Because Each Child Is Unique:

Ask your doctor if INCRELEX® is the appropriate treatment for your child.

INCRELEX® (mecasermin) is used to treat children who are very short for their age because their bodies do not make enough insulin-like growth factor-1 (IGF-1). This condition is called Severe Primary IGF-1 Deficiency or SPIGFD. INCRELEX® should not be used instead of growth hormone and has not been studied for use in children under 2 years of age.

Please see Indication and Important Safety Information below.

Olive, a former
Increlex patient,
at age 10, and
her mother, Renee.

Because Each Child Is Unique:

Ask your doctor if INCRELEX® is the appropriate treatment for your child.

INCRELEX® (mecasermin) is used to treat children who are very short for their age because their bodies do not make enough insulin-like growth factor-1 (IGF-1). This condition is called Severe Primary IGF-1 Deficiency or SPIGFD. INCRELEX® should not be used instead of growth hormone and has not been studied for use in children under 2 years of age.

Please see Indication and Important Safety Information below.

OLIVE'S JOURNEY

Olive Has Been Diagnosed With Severe Primary IGF-1 Deficiency and Shares Her Journey As a Patient.

If your child is not growing at a rate that they should be and their growth hormone levels are normal, very low levels of IGF-1 may be the cause. Talk to your doctor about having your child screened for Severe Primary IGF-1 Deficiency. Ask your doctor for more information to find out if INCRELEX® is an appropriate treatment option for your child.

INDICATION AND IMPORTANT SAFETY INFORMATION

INCRELEX® (mecasermin) is a prescription medicine used in children 2 years and older with short stature that have severely low levels of the hormone, insulin-like growth factor-1 (IGF-1). IGF-1 is needed for normal growth.

Increlex is not a substitute for growth hormone. It cannot be used for children with short stature due to low levels of growth hormone, malnutrition, when their thyroid gland doesn't make enough thyroid hormone, or when taking anti-inflammatory steroids used to manage inflammation.

IMPORTANT SAFETY INFORMATION

Always give Increlex exactly as your doctor directed.

Do not take INCRELEX if you are allergic to IGF-1 or any of its other ingredients. Report any allergic reactions.

INCRELEX should be injected under the skin and into the muscle. It should not be injected directly into a blood vessel.

INCRELEX should not be used after growth plates close which happens during puberty.

INCRELEX should not be used in children with cancerous tumors or a history of cancer.

  • Hypoglycemia (low blood sugar): INCRELEX should be administered 20 minutes before or after a meal or snack and should not be administered when the meal or snack is skipped. Checking blood glucose levels is recommended. The dose of INCRELEX may need to be adjusted until an appropriate dose is decided by your doctor.
  • Intracranial Hypertension: Increased pressure in your skull may occur because of cerebrospinal fluid buildup around your brain. Therefore, your doctor may require an eye examination at the start of Increlex treatment and periodically during the time you are taking INCRELEX.
  • Lymphoid Tissue Hypertrophy: Lymphoid tissue hypertrophy is a noncancerous increase in the number of immune cells called lymphocytes. Patients should have periodic examinations with your doctor to rule out potential complications.
  • Slipped Capital Femoral Epiphysis: Slipped capital femoral epiphysis is a disorder of adolescents where the thigh bone slips and does not fit in the hip socket correctly. Your doctor will evaluate this before the start of INCRELEX therapy.
  • Progression of Scoliosis: Your doctor will monitor you during treatment with INCRELEX if you have a history of scoliosis.
  • Malignant Neoplasia: There have been reports of cancerous tumors in children who received INCRELEX. It is unknown whether there is any relationship between INCRELEX therapy and new occurrence of tumors. Tumors were mostly reported in patients with rare genetic conditions of short stature associated with a higher risk of cancer, or in patients already at risk of cancer. The tumors were seen more frequently in patients who received INCRELEX at higher than recommended doses or at doses that produced IGF-1 levels above normal for age and sex. Your doctor will carefully monitor you during your treatment with INCRELEX for development of tumors. If cancerous tumors develop, your doctor will stop your INCRELEX treatment.
  • Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preserved Solution: Serious and fatal adverse reactions can occur in neonates and infants treated with benzyl alcohol-preserved drugs. Use of INCRELEX in infants is not recommended.

The most common adverse reactions include low blood sugar, reactions at the injection site or throughout your body, and enlarged tonsils.

You are encouraged to report negative side effects of prescription drugs by contacting 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.