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Understanding the Severe Primary IGFD Diagnosis

Is It Severe Primary IGFD?

After your child has received blood tests, your doctor will be sent a lab report. There is no single number on the report that automatically indicates that your child has severe Primary IGFD. Instead, the lab report will include a normal range that identifies the levels of growth hormone and IGF-1 expected for your child, given his or her age, sex, and the method used in that laboratory. Your doctor will evaluate these levels carefully and make a diagnosis based on these findings. The following information may point to a diagnosis of severe Primary IGFD.1

The following bullets may point to a diagnosis for severe Primary IGFD:

  • Your child is shorter than almost all other children of the same age and sex range
  • 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 including GH deficiency, poor nutrition, underactive thyroid, or chronic treatment with steroids have been ruled out1

Being 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 your child's doctor to make a precise diagnosis. Your child may need to be retested. Your child's doctor also may not yet fully understand the role of IGF-1 in contributing to growth disorder.

For all these reasons you need to be an advocate for your child. Talk to your child's doctor about having your child screened for severe Primary IGFD.

Indication and Important Safety 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.

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 breast-feeding.

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.

For Patient Product Information, click here.