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Talking with Your Child

Thoughts on How to Address Common Concerns

It's natural for anyone diagnosed with a growth disorder to have questions. For children especially, the questions and concerns regarding severe Primary IGFD may be numerous. This guide is designed to help you answer some common questions children often have about severe Primary IGFD and its treatment. Some of the questions shown here can be difficult to answer, especially since every child is different. But the suggested responses can serve as a helpful guide in communicating important information to your child.

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"Why am I shorter than other kids my age?"

"When we visited your doctor, he helped us find out that your body doesn't make enough of a special hormone that helps young bodies grow. The good news is we can replace that missing hormone with a special medicine called Increlex®."

"What can I expect during doctor visits?"

"The doctor or nurse will weigh and measure you. They will also ask questions about your treatment and whether you have any side effects."

"Why do I need to get blood tests?"

"Blood tests help the doctors discover why you're not growing. Once the doctors know what's going on, they can prescribe the right kind of treatment to help."

"Why do I need injections? Why can't I take a pill or liquid?"

"Medications come in different forms, depending on what they need to do. But the medicine you're taking would be broken down in your stomach and wouldn't work. Therefore, you have to inject it into your body tissue. And this way, it will get into your bloodstream and start working to help you grow."

"Will the injections hurt?"

"The injections are going to cause you some discomfort. Some children may get used to the pain, but no one ever gets over it completely. Instead, we can try to help make the experience as pleasant as possible by using relaxation techniques."

"Can't I skip an injection?"

"No. The only way for the medicine you're taking to work the way it should is for you to take it exactly the way you're supposed to. That means no skipping shots or doubling them up. This also means not taking an injection if you are sick or unable to eat. You want to give your body the best chance to grow."

"Will people know I'm having injections? Will they make fun of me?"

"You can get the injections in the morning, before you go to school, and at night, before bedtime, so no one has to know about the injections if you don't want them to know. Even if someone does find out, just explain that it's medicine you need to help your body grow. Many children need to take medicine for a variety of reasons, you won't be the only one."

"When will I start growing?"

"Growing up takes months and years. As we begin to replace your missing hormones, I think we'll start to see a difference, but it might take a little while. It's important that we all stay patient and positive."

"How tall will I grow?"

"It's hard to say how tall you'll grow. Every child is different. But you're taking a medicine that has been shown to help kids grow. We'll keep track of your progress and we'll talk to your doctor to make sure everything is working like it should."

"How long will I have to keep doing this?"

"Growing taller doesn't happen overnight; it takes time. Just stick with it and do what your doctor says. Remember to eat right and get enough rest, too. These things are all important to help you grow."

This guide is intended for families of children who have been prescribed Increlex. It is a tool to help you talk to your child and does not reflect all the safety and efficacy information related to Increlex. For more information, please talk to your doctor or view the full Prescribing Information for Increlex.

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.