Short Stature and Severe Primary IGFD: Overview

Physicians frequently track children's growth to ensure they are developing with a normal growth pattern. The normal growth curve falls between the 3^rd and 97^th percentile of all children of a certain age and gender.² While a child with short stature can be perfectly normal and healthy, sometimes there may be a reason behind the failure to grow properly. These reasons can include genetic abnormalities, malnutrition, chronic diseases such as Diabetes Mellitus or Renal Disease, or an endocrine disorder.³ One short stature disorder that is gaining increasing attention is severe Primary IGF-1 Deficiency (or severe Primary IGFD). Explore this section for more information on short stature disorders and severe Primary IGFD, which is a type of Primary IGFD in which IGF-1 levels are exceptionally low, despite sufficient or high growth hormone levels.

	IGF-1 and Growth Hormone Low levels of these two important hormones can result in short stature disorders. Find out more about these hormones and how they work. Learn More »		Diagnosis of Severe Primary IGFD How will your doctor determine if your child has severe Primary IGFD? Find out what your doctor looks for and what you should know about lab results. Learn More »
	What Is IGFD and Severe Primary IGFD? IGFD is a short stature disorder caused by low levels in the body of IGF-1, an important hormone needed for growth. Severe Primary IGFD is a type of Primary IGFD in which IGF-1 levels are exceptionally low, despite sufficient or high growth hormone levels. Read more about the different types of IGFD and what you should know about each. Learn More »		Treatment of Severe Primary IGFD Learn how treatment works to restore IGF-1 levels and what you should know about Increlex®, the only FDA-approved therapy for severe Primary IGFD. Learn More »
	The Testing Process Diagnosing a short stature disorder can be a complex process. Learn what to expect from the testing process... and what to ask for. Learn More »

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.