How Does Increlex^® Work?

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Increlex is a liquid that contains man-made insulin-like growth factor (IGF-1), which is the same as the IGF-1 made by your body. Increlex, the only FDA-approved treatment for severe Primary IGFD, works by replacing the IGF-1, that your child’s body is lacking. It is different than growth hormone therapy. Children with severe Primary IGFD already produce enough growth hormone—what they need is replacement of IGF-1 specifically. How does Increlex go about replacing IGF-1?

• IGF-1 is injected under the skin and enters the bloodstream
• Some IGF-1 binds with carrier proteins, which move it throughout the blood vessels
• IGF-1 then arrives at growth plates, which are located near the ends of bones
• When IGF-1 arrives at the growth plate, bone cells divide, resulting in growth

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.

IGF-1 Is an Important Factor in the Growth of Children

The Difference between IGF-1 and Growth Hormone

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Low levels of hormones, or body messengers, cause some short stature disorders. There are a number of critical hormones that are responsible for growth in children. Two of the most important are growth hormone and IGF-1. The first, growth hormone, is produced in the pituitary gland, which is a pea-sized gland located at the base of the brain. Growth hormone travels throughout the body. When it reaches the liver, it binds to receptors on liver cells, stimulating the liver to make a second hormone, insulin-like growth factor, or IGF-1.

IGF-1 is a critical factor in the growth of children.

The binding of IGF-1 to its receptors is responsible for the following changes in the body⁵:

• Increased protein synthesis
• Cell growth
• Increased cartilage formation and growth
• Skeletal growth

So, even if a child has normal levels of growth hormone, he or she still may not be growing properly. In particular, for children with severe Primary IGFD, exceptionally low levels of IGF-1 may be responsible. Children with normal growth hormone levels and exceptionally low IGF-1 levels may have a condition called severe Primary Insulin-like Growth Factor Deficiency, or severe Primary IGFD.

What does this mean for parents? Above all, it means that children who are tested for short stature disorders should be given a blood test that screens for severe Primary IGFD. The two results together will provide their physician with a more complete picture from which to make a more accurate diagnosis.

What to Know about Injecting Increlex^®

Overcoming Injection Anxiety

Because Increlex involves twice-daily injections, your child may be anxious about getting them, which can make you anxious, too. Fortunately, there are ways you can reduce this anxiety:

Develop a routine. Give Increlex injections around the same time each day, and choose a quiet and calm place, separate from where your child plays and eats, and away from the hustle and bustle of the house. Because Increlex is injected in the morning and evening, your child doesn’t have to worry about needing injections while at school. This should ease fears he might have about other kids finding out.

Relax. Create a soothing atmosphere. Play your child’s favorite music or videos as a distraction, or tell stories and jokes to distract him. Also teach your child breathing techniques, which can help to calm the emotions your child may be feeling.

Engage in positive thinking. Work with your child to think of ways he can mentally “escape” during the injection. Have your child practice visualizing a place or activity that makes him happy and concentrating hard on that mental picture instead of on the shot.

Choose timing wisely. Try to schedule the injection immediately before an activity that your child really enjoys, such as bath time or a favorite TV show. That way, your child can look ahead to the treat instead of focusing on the injection. Also, be sure your child eats shortly before or shortly after getting his injection. This will help to avoid hypoglycemia (low blood sugar).

Project the right attitude. Be careful that you don’t contribute to anxiety by making a big deal out of the injection. Don’t be dramatic, apologetic or overly sympathetic about it. Remain matter-of-fact and business-like during the few minutes you spend giving the injection, and then always give your child a big hug and words of praise afterward.

Talk it out. It is helpful to pick a time when you’re not giving injections to talk with your child about his anxiety. What goes through your child’s mind when it’s time to get the shot? Are there particular words or phrases your child tends to think about when feeling anxious? Try to come up with a sort of mantra—a positive and helpful phrase or sentence your child can repeat to himself whenever anxious thoughts start to creep in.