The Safety Profile of Increlex^®

Years of research were conducted before Increlex was approved by the Food and Drug Administration. In trials, no patients dropped out due to side effects.^1,7

Increlex may cause some side effects, which can be serious.¹ One such side effect is low blood sugar or hypoglycemia. Increlex may lower blood sugar levels like insulin. It is important to 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 low blood sugar. 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; fast or irregular heartbeat. Severe hypoglycemia may cause unconsciousness, seizures, or death. If you take Increlex, you should avoid participating in high risk activities (such as driving) within 2 to 3 hours after Increlex injection, especially at the beginning of Increlex treatment.

Before beginning treatment with Increlex, your doctor or nurse will explain to you how to treat hypoglycemia. You/your child should always have a source of sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of hypoglycemia occur. For severe hypoglycemia, if your child is not responsive and cannot drink sugar-containing fluids, you should give an injection of glucagon. Your doctor or nurse will instruct you how to give the injection. Glucagon raises the blood sugar when it is injected. It is important that your child has a well-balanced diet including protein and fat such as meat and cheese in addition to complex carbohydrate-containing foods.

Other possible side effects of Increlex include enlarged tonsils; increased pressure in the brain (intracranial hypertension); a bone problem called slipped capital femoral epiphysis; worsened scoliosis (caused by rapid growth); allergic reactions; and injection-site reactions such as loss of fat, increase of fat, or pain, redness, or bruising.

For more information about Increlex side effects, view the Patient Information or talk to your child's doctor.

It is important to let your doctor know if your child has any history of low blood sugar, or seizures. Talk to your doctor to determine if Increlex is right for your child and about getting the right dose to safely maximize your child's growth. Increlex may not be for everyone. Your child should not take INCRELEX if he: 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.

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.