Guide to Living with Severe Primary IGFD

When your child is diagnosed with severe Primary IGFD, it seems like there's so much to know. How will your child get started on treatment? Will your insurance company pay for therapy? How can you support your child's physical and emotional needs? What other resources are available to help you learn more and network with other severe Primary IGFD patients and their families? Our "Guide to Living with Severe Primary IGFD" provides tips in all of these areas to give you the valuable information and support you need.

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Getting Started on Increlex^®

Understand the Process Involved

• Once your child has been diagnosed with severe Primary IGFD and prescribed Increlex, your doctor will need you to complete forms in order to begin Increlex treatment and obtain necessary insurance coverage
• Be sure to be proactive in your insurance coverage decisions. Stay in close contact with Patient Care Liaisons (PCLs) from PACE^SM. PACE is the Patient Access, Care and Education program provided to patients taking Increlex. Don't be afraid to ask questions of PACE representatives or your insurance company if there's anything you're unsure of or to follow up on any outstanding issues.

Enroll in a Specialty Pharmacy

• Increlex is available only through a specialty pharmacy. A specialty pharmacy provides injectable and infusion (or IV) therapies that generally require more complex care, or that require specialized delivery and administration on an ongoing basis. Unlike retail pharmacies, specialty pharmacies often offer special support services to patients. They will also deliver your medication directly to you to make sure that delivery is handled properly. A PACE representative will help you identify and enroll with a specialty pharmacy.

Know the Right Dosing

• Your physician or healthcare provider will determine the correct dose of Increlex to administer to your child, taking into account your child's weight, age and other factors. This information will be given to you, along with personal instructions and a dosing sheet that will make it easy for you to be as accurate and safe as possible

Overcome Injection Anxiety

• Increlex requires twice-daily injections. This may make both you and your child uneasy or anxious at first. The injections are going to cause some discomfort. Some children may get used to the pain, but no one ever gets over it completely. For both of you, there are steps you can take to lessen the anxiety: develop a routine, relax, engage in positive thinking, try to schedule the injection before a favorite activity, and talk out your child's fears
• Your doctor or nurse can train you in how to give injections, as can PACE PCLs. PACE also 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*

Set Realistic Growth Expectations

• Children often want to see immediate results in their growth progress. But results take time. Talk to your doctor about the right growth expectations for your child. Then track your child's progress and be sure to provide positive reinforcement. An interactive Growth Tracking Tool is available on the Increlex website (www.Increlex.com), which allows you to monitor your child's growth progress over time.

Stick with Increlex

• While taking Increlex as prescribed may seem difficult during some days, it is important that your child takes his or her medication as directed and regularly over time in order to see results. This means no skipped doses, no missed prescription refills, and ongoing dedication to taking Increlex as directed

Tips for Navigating the Insurance Process

• Ask questions, both of your insurance company and of your doctor's office. Find out what your insurance plan covers and what you can do to move the reimbursement process along.
• Work with your doctor. After prescribing Increlex, your doctor will need you to sign forms to begin therapy and get the insurance coverage you need. These forms allow everyone involved in your treatment—doctor, pharmacy, health insurance planner, reimbursement planner—to work together.
• Know that help is available. Ipsen offers PACE, a Patient Access, Care and Education program to help you and your child gain access to therapy, training and education. This program even provides a 30-day supply of Increlex to qualified patients and up to seven months of Increlex while you're waiting for your insurance to kick in.* Talk with your doctor's office to learn about the additional resources available to you.
• Be patient but persistent. Know that the reimbursement process can be a lengthy one. But don't be shy about following up on questions or unresolved matters.

Supporting Your Child's Physical and Emotional Needs

• Communicate and educate: Since you have limited time with your child's physician, most information your child receives will come from you. Help your child understand how growth works — and why sometimes it doesn't. The more your child knows, the more he or she will want to participate. Speak with nurses, too—they're great allies.
• Encourage: Give your child positive reinforcement whenever possible to build self-esteem and remind him of how proud you are. Help your child keep a positive attitude, think optimistic thoughts, and celebrate every accomplishment with gusto! Show him his progress as he grows.
• Support: There will inevitably be dark days — when your child is being teased at school, or feels discouraged if growth isn't happening quickly enough. Be sure to talk about these feelings with your child, so that he knows he's not alone.
• Be an advocate: Work with your child to list worries and questions he or she might want to discuss with the doctor or nurse, and get your child involved in developing plans and schedules. Giving your child a voice in the process and encouraging your child to stand up for what he or she wants, will make your child feel empowered.

Supporting Your Own Needs

Build a support network. Because living with a growth disorder can feel isolating, it's important to reach out to others. The Magic Foundation offers support networks for parents, allowing families with similar stories to share experiences and offer support. Visit their website for more information.

Tap into resources to help with financial concerns. Figuring out how to pay for therapy can be stressful. But help is available. Ipsen offers PACE, a Patient Access, Care and Education program to patients taking Increlex. This program provides a 30-day supply of Increlex to qualified patients and up to seven months of Increlex while you're waiting for your insurance to kick in.* Talk with your doctor's office to learn about the additional resources available to you.

Overcome injection anxiety. Because Increlex requires twice-daily injections, your child may be anxious, which can cause you to feel anxious, too. There are steps you can take to reduce this anxiety:

• Develop a routine
• Relax
• Engage in positive thinking
• Try to schedule the injection before a favorite activity
• Talk it out with your child

Helpful Resources

The Magic Foundation
The Magic Foundation is a national, nonprofit organization that provides support services for families afflicted with a wide variety of growth-related disorders. For more information, visit their website.

PACE
PACE is a Patient Access, Care, and Education program offered by Ipsen. PACE can help you and your child gain access to therapy, training, and education.

*Patient Eligibility Criteria: Patient has been diagnosed with severe Primary IGFD. Patient’s prescriptions are not paid in part or full by any state-funded or federally-funded programs, including but not limited to Medicare, Medicaid, Medigap, VA, DOD or TriCare. Patient is not a resident of Massachusetts. Starter therapy is available for up to 8 months as long as insurance coverage for Increlex is actively being pursued by the prescriber and the patient's insurance company has not yet communicated a final coverage decision.

This guide is intended for families of children who have been prescribed Increlex. It does not reflect all the safety and efficacy information related to Increlex. For specific treatment guidelines related to your child, please talk to your doctor.

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.