Terms and Conditions

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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 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.
• 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.
• 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.
• 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).
• Allergic reactions. Call your child’s doctor right away if your child shows signs of an allergic reaction, such as rash or hives. Seek immediate medical attention if your child has trouble breathing or goes into shock (becomes unconscious).
• 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 see the full Patient Prescribing Information.