Insurance Information: Paying for and Receiving Increlex^®

PACE Helps the Reimbursement and Delivery Process Go Smoothly

When your child has a medical condition that requires ongoing treatment or special medication, suddenly dealing with insurance matters becomes a whole new challenge. When initiating Increlex therapy, there are certain things to keep in mind:

1. Your doctor will submit an enrollment form to PACE
   • If your doctor decides that Increlex is right for you, he or she will complete and submit an enrollment form.
   • The form includes your prescription for Increlex and will be faxed directly to PACE.
2. A Patient Care Liaison (PCL) from PACE will contact you
   • A PCL from PACE will contact you once her or she receives the form from your doctor. It is important that you speak with the PCL so he/she can provide important information about insurance benefits related to your prescription. The PCL will also work with you to arrange for injection training if requested by your doctor.
   • Please note, delivery of your prescription for Increlex could be delayed if you do not return these calls.
3. A specialty pharmacy will send your shipment of Increlex therapy
   • Increlex is dispensed through a limited number of specialty pharmacies. Your prescription will be sent directly to you or your doctor by the specialty pharmacy. The specialty pharmacy will coordinate shipments of your refill prescriptions as well.
   • The specialty pharmacy must speak with you before they can send your medication so please return these calls promptly.

Tips for Navigating the Insurance Process

• Ask questions of PACE, of your insurance company and of your doctor's office. Find out what you need to know and what you can do to move the process along.
• Work with your doctor. After determining which treatment your child needs, your doctor may need you to sign forms to get your child started on therapy. These forms allow everyone involved in treatment—doctor, specialty pharmacy, insurance company and PACE—to work together.
• 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. Some frequently asked questions may all ready be answered for you.

Learn More about PACE.

Download the PACE brochure (.pdf) now.

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.