Doctor Discussion Guide

Points to discuss with your Pediatric Endocrinologist

Is your child right for Increlex^®? Knowing the answer to this question begins with an accurate diagnosis of your child's condition—which may take some time.

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For the undiagnosed patient:

• Where does my child fall within the range of heights for children his age? In what percentile does my child's height fall?
• What is the difference between growth hormone deficiency and IGFD?
• How do you determine this?
• What screening tests will you perform in order to diagnose my child?
• What does each of the tests entail? What should I expect and how should I prepare my child?
• Will you screen for IGF-1 deficiency?
• How long will it take to obtain the results?
• Could my child have severe Primary IGFD?

For the child who has not responded to growth hormone therapy after 6 to 12 months:

• Why do you think my child is not growing properly?
• Have you performed a second test to check the accuracy of the diagnosis?
• Have you screened my child for IGF-1 deficiency?
• Is my child's level of growth hormone in the normal range?
• Could my child have severe Primary IGFD?

For the patient diagnosed with severe Primary IGFD who has not yet started therapy:

• What treatment are you prescribing for my child and why?
• What type of growth should I expect in the first year, should we choose to treat my child with Increlex?
• What should I know about severe Primary IGFD?

For the patient who has been prescribed Increlex:

• What should I know about dosing Increlex?
• How do I administer Increlex? Is there help?
• What if my child attends a sleepover party or overnight trip—how do we work injections into the picture?
• What are the side effects associated with Increlex?
• What increases in growth can be expected from treatment?
• Is there anything else I should know about Increlex?

Starting Treatment

Ipsen is proud to offer PACE^SM, our Patient Access, Care and Education program. PACE offers a complimentary Increlex Starter Kit, which provides an initial 30-day supply of Increlex to qualified patients* and up to an additional seven months of Increlex while you're waiting for your insurance to kick in*;

*Patients must be diagnosed with severe Primary IGF-1 Deficiency. Patients covered in part or in full by Medicare, Medicaid, or other state or federally funded programs, and Massachusetts residents, are not eligible for these programs. Void where prohibited by law, taxed, or restricted. Contact PACE at 866.435.5677 for more details regarding eligibility.

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.