Increlex 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.

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

Increlex is not for use in children who have growth hormone deficiency, malnutrition, underactive thyroid, or those who are taking long-term steroid medications.

Increlex should not be given to a child who has cancer, or a child who has finished growing (the bone growth plates are closed).

Increlex 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 this medicine, 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.

Increlex s injected under the skin. You and your child may be shown how to use injections at home. Make sure you fully understand how to give the injection and properly dispose of used needles and syringes.

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

Increlex is injected under the skin. You may be shown how to use injections at home. Do not give this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes. Do not inject this medicine into a vein.

Increlex is usually given twice per day, shortly before or after the child eats a meal or snack. Skip a dose if the child will miss a meal. Mecasermin can cause low blood sugar, which may be worse if the child does not eat.

Tell your doctor if your child has any changes in weight. Increlex doses are based on weight and any changes may affect the dose.

Your care provider will show you the best places on your child's body to inject Increlex. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medicine.

While using Increlex, your child may need frequent examinations and medical tests. The child's blood sugar may also need to be checked often.

Watch your child for signs of low blood sugar (hypoglycemia). Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar available in case the child has low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help the child in an emergency.

Keep track of how many days in a row your child has had low blood sugar symptoms after receiving a dose of this medicine.

Call the doctor if hypoglycemia symptoms do not get better after eating or drinking a sugar source.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Store this medicine in the refrigerator. Protect from light and do not freeze. Throw away the vial 30 days after opening it, even if it still contains unused Increlex.

Usual Pediatric Dose for Primary IGF-1 Deficiency:

Initial dose: 0.4 to 0.8 mg/kg subcutaneously 2 times a day for at least 7 days

Maximum dose: 0.12 mg/kg subcutaneously 2 times a day

Comments:
-Not a substitute to growth hormone (GH) for approved GH indications.

Uses: Treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Your child should not use Increlex if he or she is allergic to mecasermin, or if:

• the child has cancer; or

• the child has finished growing and his or her bone growth plates are closed.

To make sure Increlex is safe for your, tell the doctor if your child has:

• diabetes;

• kidney disease;

• liver disease; or

• a curved spine (scoliosis).

It is not known whether Increlex will harm an unborn baby if used during pregnancy.

It is not known whether mecasermin passes into breast milk or if it could harm a nursing baby.

Increlex is not approved for use by anyone younger than 2 years old.

Use the missed dose as soon as you remember. Be sure the child eats within 20 minutes before or after the injection. If the child skips a meal, do not use Increlex. Wait until the next meal.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of mecasermin can cause severe hypoglycemia.

Symptoms of severe hypoglycemia may include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, or seizure (convulsions).

Long term use of high mecasermin doses can lead to unusual or excessive growth in any part of the body.

Increlex may impair thinking, reactions, or physical abilities. For the first 2 to 3 hours after an injection, the child should avoid doing anything that requires alertness or coordination.

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

Call your doctor at once if your child has:

• pain in the hip or knee, walking with a limp;

• low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

• swollen tonsils - snoring, breathing problems during sleep, pain or fullness in the ear, hearing problems; or

• increased pressure inside the skull - headache with vision problems, nausea, pain behind the eyes.

Common Increlex side effects may include:

• low blood sugar;

• swollen tonsils; or

• an allergic reaction.

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.

Other drugs may interact with mecasermin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines your child uses now and any medicine the child starts or stops using.