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) 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 receive INCRELEX?
Your child should not receive INCRELEX if your child: is allergic to mecasermin or any of the ingredients in INCRELEX; has finished growing; has any cancerous tumors or growths; or has a history of cancer. 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 medical conditions, including if your child has diabetes; a curved spine (scoliosis); or is pregnant or breast-feeding.
Tell your child’s doctor about all the medicines (prescription and over-the-counter), vitamins, and herbal supplements your child takes. Especially tell your child’s doctor if your child takes insulin or other anti-diabetes medicines; a change in dose may be needed.
What are the possible side effects of INCRELEX?
INCRELEX may cause serious side effects, including:
- Low blood sugar (hypoglycemia). INCRELEX may lower blood sugar levels. It is important to only give your child INCRELEX 20 minutes before or 20 minutes after a meal or snack to reduce the chances of low blood sugar. Do not give your child INCRELEX if your child cannot eat. Signs of low blood sugar include: dizziness; tiredness; restlessness; hunger; irritability; trouble concentrating; sweating; nausea; and fast or irregular heartbeat. Severe low blood sugar may cause unconsciousness, seizures, or death. Your child should avoid participating in high risk activities (e.g. driving, exercise, etc.) within 2 to 3 hours after an INCRELEX injection, especially at the beginning of treatment. Your child should always have a source of sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of low blood sugar happen. For severe low blood sugar, if your child is not responsive and cannot drink sugar-containing fluids, you should get emergency medical help for your child right away.
- Allergic reactions are a serious but common side effect of INCRELEX. Call your child’s doctor right away if your child gets a rash or hives, which generally appear minutes to hours after the injection and may sometimes occur at many places on the skin. Stop taking INCRELEX and get medical help right away if your child has trouble breathing or goes into shock, with symptoms like dizziness, pale, clammy skin or passing out. INCRELEX can also cause reactions at the injection site including: loss of fat (lipoatrophy); increase of fat (lipohypertrophy); pain; redness; or bruising.
- 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.
- Enlarged tonsils. Signs include: snoring, difficulty breathing, sleep apnea (a condition where breathing stops briefly during sleep), or fluid in the middle ear.
- A bone problem called slipped capital femoral epiphysis, when the top of the upper leg bone (femur) slips apart. Get medical help right away if your child develops a limp or has hip or knee pain.
- Worsened scoliosis (caused by rapid growth).
- Tumor Growths. Several cases of cancerous tumors have been observed in children who received INCRELEX. Tell your doctor immediately if your child develops any new growths or symptoms of cancer.
- Benzyl alcohol toxicity. Benzyl alcohol, a preservative in INCRELEX, can cause serious side effects, including death in infants.
The most common side effects of INCRELEX include: low blood sugar (hypoglycemia), injection site reactions, allergic reactions and enlarged tonsils.
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 may report side effects to FDA at 1-800-FDA-1088.
What is INCRELEX?
INCRELEX® (mecasermin) 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. It is not known if INCRELEX is safe and effective in children under 2 years of age.
Who should not use INCRELEX®?
Your child should not receive INCRELEX if your child: has any tumors or growths, noncancerous or cancerous; or has a history of cancer or a condition or family history that increases the risk of cancer; is allergic to mecasermin or any of the ingredients in INCRELEX; or has finished growing. Your child should never receive INCRELEX through a vein.
June 24, 2019 Announcement:
IMPORTANT DRUG WARNING
Important new safety information about tumor growth (noncancerous and cancerous). Please see Important Safety Information and updated Prescribing Information.
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