Instructions for Use
How should my child use lncrelex®
1.Use lncrelex exactly as prescribed for your child. Your doctor or nurse should teach you how to inject lncrelex. Do not give your child lncrelexu unless you understand all of the instructions. See the "instructions for Use" at the end of this leaflet.
2.Inject lncrelex under your child's skin shortly (20 minutes) before or after a meal or snack. Skip your child's dose of lncrelex if your child cannot eat for any reason. Do not make up the missed dose by giving two doses the next time.
3.lnject lncrelex just below the skin in your child's upper arm, upper leg (thigh), stomach area (abdomen), or buttocks. Never inject into a veinor muscle. Change the injection site for each injection ("rotate the injection site”).
4.Only use lncrelex that is clear and colorless. If your child's lncrelex is cloudy or slightly colored, return it for a replacement.
Be sure to follow these steps (or Instructions for Use), for Increlex® (mecasermin [rDNA origin] injection):
Preparing the dose
1.Wash your hands before preparing Increlex for your child's injection.
2.Use a new disposable needle and syringe every time you give a dose. Use syringes and needles only once. Dispose of them properly. Never share needles and syringes.
3.Check the liquid to make sure it is clear and colorless. Do not use after the expiration date or if it is cloudy or if you see particles.
4.If you are using a new vial, remove the protective cap. Do not remove the rubber stopper.
Inject Increlex as instructed by your child's doctor.
Do not give the Increlex injection if your child is unable to eat within 20 minutes before or after the injection.
2.Use alcohol or soap and water to clean the skin where you are going to inject your child. The injection site should be dry before you inject.
5.Follow your healthcare provider's instructions for throwing away the needle and syringe. Do not recap the syringe. The used needle and syringe should be placed in a sharps container (such as a red biohazard container), hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Containers should be sealed and disposed of properly. Your doctor's office or an IPSEN CARES® representative can tell you who to contact to arrange for pickups of biohazardous waste.
Who should not use INCRELEX?
Your child should not take INCRELEX if your child: has finished growing, has cancer, has other causes of growth failure, or is allergic to mecasermin or any of the inactive ingredients in INCRELEX. 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, kidney problems, liver problems, allergies, curved spine (scoliosis), or is pregnant or breast-feeding.
Tell your child’s doctor about all the medicines (prescription and nonprescription), vitamins, and herbal supplements your child takes. Especially tell your child’s doctor about insulin or other anti-diabetes medicines; a dose adjustment may be needed.
What are possible side effects of INCRELEX?
INCRELEX may cause the following side effects, 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. 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, and fast or irregular heartbeat. 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.
- 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.
- 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 and nausea with vomiting.
- A bone problem called slipped capital femoral epiphysis. This happens when the top of the upper leg bone (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).
- 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. If hives do occur, they 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.
INCRELEX can cause reactions at the injection site including: loss of fat, increase of fat, pain, redness, or bruising, which can be avoided by changing the injection site at each injection.
These are not all the side effects of INCRELEX. Call your child’s doctor if your child has side effects that are bothersome or that do not go away. 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.
What is INCRELEX?
INCRELEX is a prescription medicine used to treat children who are very short for their age because their bodies do not make enough insulin-like growth factor-1 (IGF-1). This condition is called severe primary IGF-1 deficiency. INCRELEX 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 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.
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