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Important Safety Information & Indication

Who should not use INCRELEX?

Your child should not take INCRELEX if your child: has finished growing, has cancer, has other causes of growth failure, or is allergic to mecasermin or any of the inactive ingredients in INCRELEX. Your child should never receive INCRELEX through a vein.

What should I tell my child’s doctor before my child starts INCRELEX?

Tell your child's doctor about all of your child's health conditions, including if your child has diabetes, kidney problems, liver problems, allergies, curved spine (scoliosis), or is pregnant or breast-feeding.

Tell your child’s doctor about all the medicines (prescription and nonprescription), vitamins, and herbal supplements your child takes. Especially tell your child’s doctor about insulin or other anti-diabetes medicines; a dose adjustment may be needed.

What are possible side effects of INCRELEX?
INCRELEX may cause the following side effects, 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. Do not give your child INCRELEX if your child is sick or cannot eat. Signs of low blood sugar are: dizziness; tiredness; restlessness, hunger, irritability, trouble concentrating, sweating, nausea, and fast or irregular heartbeat. 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 and nausea with vomiting.
  • A bone problem called slipped capital femoral epiphysis. This happens when the top of the upper leg bone (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. 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. If hives do occur, they 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.

INCRELEX can cause reactions at the injection site including: loss of fat, increase of fat, pain, redness, or bruising, which can be avoided by changing the injection site at each injection.

These are not all the side effects of INCRELEX. Call your child’s doctor if your child has side effects that are bothersome or that do not go away. 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.

What is INCRELEX?

INCRELEX is a prescription medicine 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. INCRELEX should not be used instead of growth hormone. INCRELEX has not been studied in children under 2 years of age.

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

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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