ildren who are very short for their age because their bodies do not make enough IGF-1. This condition is called primary IGF-1 deficiency. IGF-1 should not be used instead of growth hormone.
INCRELEX® has not been studied in children under 2 years of age.
Who Should Not Use INCRELEX®?
Your child should not take INCRELEX® if your child:
Has finished growing (the bone growth plates are closed)
Has cancer
Has other causes of growth failure
Is allergic to mecasermin or any of the inactive ingredients in INCRELEX®. Check with your child's doctor if you are not sure.
Your child should never receive INCRELEX® through a vein.
What should I tell my child's doctor before my child starts INCRELEX®?
Tell your child's doctor about all of your child's health conditions, including if your child:
Has diabetes
Has kidney problems
Has liver problems
Has a curved spine (scoliosis)
Is pregnant or breast-feeding.
Tell your child's doctor about all the medicines your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your child's doctor if your child takes insulin or other anti-diabetes medicines. A dose adjustment may be needed for these medicines.
How Should My Child Use INCRELEX®?
Use INCRELEX® exactly as prescribed for your child. Your doctor or nurse should teach you how to inject INCRELEX®. Do not give your child INCRELEX® unless you understand all of the instructions. See the "Instructions for Use" at the end of this leaflet.
Inject INCRELEX® under your child's skin shortly (20 minutes) before or after a meal or snack. Skip your child's dose of INCRELEX® if your child cannot eat for any reason. Do not make up the missed dose by giving two doses the next time.
Inject INCRELEX® just below the skin in your child's upper arm, upper leg (thigh), stomach area (abdomen), or buttocks. Never inject it into a vein or muscle. Change the injection site for each injection ("rotate the injection site").
Only use INCRELEX® that is clear and colorless. If your child's INCRELEX® is cloudy or slightly colored, return it for a replacement.
What are the Possible Side Effects of INCRELEX®?
INCRELEX® may cause the following side effects, which can be serious:
Low blood sugar (hypoglycemia). INCRELEX® may lower blood sugar levels like insulin. It is important to 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 low blood sugar. Do not give your child INCRELEX® if your child is sick or cannot eat. Signs of low blood sugar are:
Dizziness
Tiredness
Restlessness
Hunger
Irritability
Trouble concentrating
Sweating
Nausea
Fast or irregular heartbeat
Severe hypoglycemia may cause unconsciousness, seizures, or death. If you take INCRELEX®, you should avoid participating in high risk activities (such as driving) within 2 to 3 hours after INCRELEX® injection, especially at the beginning of INCRELEX® treatment.
Before beginning treatment with INCRELEX® your doctor or nurse will explain to you how to treat hypoglycemia. You/your child should always have a source of sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of hypoglycemia occur. For severe hypoglycemia, if your child is not re |
