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Brand Names: Increlex

Generic Name: mecasermin (Pronunciation: ME ka SER min)

• What is mecasermin (Increlex)?
• What are the possible side effects of mecasermin (Increlex)?
• What is the most important information I should know about mecasermin (Increlex)?
• What should I discuss with my healthcare provider before using mecasermin (Increlex)?
• How should I use mecasermin (Increlex)?
• What happens if I miss a dose (Increlex)?
• What happens if I overdose (Increlex)?
• What should I avoid while using mecasermin (Increlex)?
• What other drugs will affect mecasermin (Increlex)?
• Where can I get more information?

What is mecasermin (Increlex)?

Mecasermin is a man-made form of insulin-like growth factor-1 (IGF-1), a substance that is normally produced in the body. IGF-1 is important for the growth of bones and muscles.

Mecasermin is used to treat growth failure in children whose bodies do not make enough IGF-1.

Mecasermin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of mecasermin (Increlex)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your child's face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

• blurred vision, headache or pain behind the eyes, sometimes with vomiting;
• pain in the hip or knee, walking with a limp;
• seizure (convulsions); or
• swollen tonsils - snoring, breathing problems during sleep, ear pain, feeling of fullness in the ears, muffled hearing.

Less serious side effects may include:

• headache;
• dizziness;
• vomiting;
• mild joint pain;
• thickening of facial skin;
• easy bruising; or
• pain, redness, bruising, or skin changes where the medication was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about mecasermin (Increlex)?

Your doctor child should not use this medication if he or she is allergic to mecasermin, or if the child has cancer or has finished growing and his or her bone growth plates are closed. Mecasermin is not for use in children who have growth hormone deficiency, malnutrition, underactive thyroid, or those who are taking long-term steroid medications.

Before your child receives mecasermin, tell the doctor if your child has diabetes, kidney disease, liver disease, a curved spine (scoliosis), or if the child has ever had an allergic reaction to a preservative called benzyl alcohol.

Mecasermin is given as an injection under the skin. You and your child will be shown how to inject the medicine at home. Make sure you fully understand how to give the injection and properly dispose of used needles and syringes.

Do not give this medication as an IV injection directly into a vein. Use a different place on your child's upper arm, thigh, stomach, or buttocks each time you give your child a mecasermin injection.

Give the mecasermin injection 20 minutes before or after the child eats a meal or snack. Skip the dose if the child's meal or snack will be missed. Mecasermin can cause low blood sugar, which may be worse if the child does not eat before or after the injection.

Call your doctor at once if your child has a serious side effect such as blurred vision, headache or pain behind the eyes (sometimes with vomiting), pain in the hip or knee, walking with a limp, seizures, or swollen tonsils (snoring, breathing problems during sleep, ear pain, feeling of fullness in the ears, muffled hearing).

Mecasermin can cause side effects that may impair thinking, reactions, or physical abilities. The child should avoid driving or doing anything else that requires alertness or coordination for the first 2 or 3 hours after a mecasermin injection.

Take care not to let your child's blood sugar get too low while using mecasermin. Know the signs of low blood sugar (hypoglycemia) and how to recognize them