Could it be severe primary IGFD?

Learn more and talk to your child's Doctor.

Growth hormone is produced in the pituitary gland located at the base of the brain and released into the bloodstream. When it reaches the liver, it stimulates the liver to make another critical growth hormone, insulin-like growth factor, or IGF-1. Growth can slow when the pituitary gland fails to make enough growth hormone, which in turn affects IGF-1.

Testing and diagnosis

Initial tests may show your child has low levels of growth hormone, and your physician may suggest beginning growth hormone treatment. However, a child whose tests show normal levels of growth hormone may still not be growing properly, so their IGF-1 levels should be tested as well. Then, if tests show that IGF-1 levels are low, a growth hormone stimulation (STIM) test should be conducted next, to identify whether your child has severe primary insulin-like growth factor deficiency (IGFD).

Be proactive

It's important to ask that these diagnostic tests be conducted, as there is a specific treatment for severe primary IGFD. What's more, having your child tested for both growth hormone and IGF-1 can give the doctor a more complete picture.

Is it severe primary IGFD?

Your child's doctor will measure your child's levels of GH and IGF-1. The normal reference ranges may vary depending on the brand of assay used. The doctor will compare your child's numbers against the normal ranges also shown in the report, carefully evaluate them, and make a diagnosis.

Factors that may point to a diagnosis of severe primary IGFD:

  • Your child is shorter than most other children of the same age range and gender
  • Levels of IGF-1 in the body are much lower than normal
  • Levels of growth hormone in the body are normal or even high; your child's doctor will let you know what levels of growth hormone are considered normal

Other causes of low IGF-1 that should be ruled out include growth hormone deficiency, poor nutrition, underactive thyroid, or chronic treatment with steroids.

Be an advocate for your child

Testing is not a perfect science. Some tests may be inaccurate, or the results may be unclear, and may not permit the doctor to make a precise diagnosis. Your child may need to be retested. Also, some doctors may not yet fully understand the role of IGF-1 in contributing to growth. It's important that you be patient and persistent.

Your involvement is key. Once your child's treatment begins, the amount (dose) of their medication becomes important because it needs to keep up with gains they are making in height and weight. It's good to check in on a regular basis with the doctor or nurse, so your child's dose can be adjusted, if needed. You can also sign up below for treatment updates, information, and reminders.

LEARN THE BASICS OF GROWTH HORMONE AND SEVERE PRIMARY IGF DEFICIENCY

Important Safety Information

Who should not use INCRELEX®?

Your child should not take INCRELEX if your child: has finished growing (the growth plates at the end of the bones are closed); has cancer; has other causes of growth failure; OR is allergic to mecasermin or any of the inactive ingredients in INCRELEX. INCRELEX has not been studied in children under 2 years of age and should never be used in newborns. Your child should never receive INCRELEX through a vein.

Before your child takes INCRELEX, you should tell your child's doctor about:

All of your child's health conditions, including: diabetes, kidney problems, liver problems, allergies, scoliosis (curved spine), pregnancy, or breastfeeding.

All the medicines (prescription and nonprescription), vitamins, and herbal supplements your child takes, especially insulin or other anti-diabetes medicines, which may require dose adjustment of these medicines.

What are possible side effects of INCRELEX (some of which can be serious)?

Low blood sugar (hypoglycemia). Only give your child INCRELEX right before or right after (20 minutes on either side of) a snack or meal to reduce the chances of hypoglycemia. Signs include: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, and fast or irregular heartbeat. Do not give your child INCRELEX if your child is sick or cannot eat.

Severe hypoglycemia may cause unconsciousness, seizures, or death. People taking INCRELEX should avoid participating in high risk activities (such as driving) within 2 to 3 hours after an INCRELEX injection.

Increased pressure in the brain (intracranial hypertension). INCRELEX, like growth hormone, can sometimes cause a temporary increase in pressure within the brain. Symptoms include persistent headache, blurred vision, and nausea with vomiting.

Allergic reactions. Your child may have a mild or serious allergic reaction with INCRELEX. Call your child's doctor right away if your child gets a rash or hives. Hives, also known as urticaria, appear as a raised, itchy skin reaction. Hives appear pale in the middle with a red rim around them. Hives generally appear minutes to hours after the injection and may sometimes occur at numerous places on the skin. Get medical help immediately if your child has trouble breathing or goes into shock, with symptoms like dizziness, pale, clammy skin, and/or passing out.

Enlarged tonsils. Signs include: snoring, difficulty breathing or swallowing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear.

A bone problem called slipped capital femoral epiphysis. This happens when the top of the upper leg (femur) slips apart from the rest of the bone. Seek immediate medical attention if your child develops a limp or has hip or knee pain.

Worsened scoliosis (caused by rapid growth).

Injection site reactions including: swelling, loss of fat, increase of fat, pain, redness, or bruising. This can be avoided by changing/rotating the injection site at each injection.

Your child's doctor is your primary source of information about treatment. For more information, please talk to your doctor and download and review the full Patient Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Click here to view Increlex® Full Prescribing Information and Patient Information

Who is INCRELEX for?

INCRELEX is used to treat children who are very short for their age because their bodies do not make enough IGF-1. This condition is called severe primary IGF-1 deficiency. INCRELEX should not be used instead of growth hormone.

Indication

Who should not use INCRELEX®?

Your child should not take INCRELEX if your child: has finished growing (the growth plates at the end of the bones are closed); has cancer; has other causes of growth failure; OR is allergic to mecasermin or any of the inactive ingredients in INCRELEX. INCRELEX has not been studied in children under 2 years of age and should never be used in newborns. Your child should never receive INCRELEX through a vein.

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