Administering Increlex:

Tips for injecting

Increlex® (mecasermin [rDNA origin] injection) is given twice a day by injection only. The doctor will give your child his or her first injection.

For the injections after that, you can learn to inject Increlex yourself. The doctor, nurse, and/or IPSEN CARES® will coordinate training to show you exactly how to deliver the dose. And while the prospect of injecting your child twice a day may seem daunting at first, there are specific things you can do (below) to help ease the injection process.

Requests to have a nurse visit the doctor's office or your home can be coordinated through IPSEN CARES.

Overcoming injection anxiety

Since treatment with Increlex involves twice-daily injections, your child may become anxious about them, which can make you anxious, too. Fortunately, there are ways you can reduce this anxiety:

Develop a routine. Give Increlex injections around the same time each day, and choose a quiet and calm place, separate from where your child plays and eats and away from the hustle and bustle of the house. Because Increlex is injected in the morning and evening, your child doesn't have to worry about needing injections while at school. This should ease fears he or she might have about other children finding out.

Set the mood. Create a cheerful atmosphere. Play your child's favorite music or videos, or tell stories and jokes. Also, teach your child breathing techniques, which can help to calm your child.

Practice positive thinking. Suggest ways your child can mentally “escape” during the injection. Have your child visualize a fun place or activity and focus on that mental picture, instead of on the injection.

Distract. Give your child something to hold and feel, like a squishy squeeze ball or one covered in tactile bumps. If your child is old enough, chewing gum or licking a lollipop might also work well.

Choose your time wisely. Try to schedule the injection immediately before an activity that your child really enjoys, such as a favorite TV show or video game. That way, your child can look ahead to the treat instead of focusing on the injection. Importantly, be sure your child eats shortly before or shortly after getting the injection (+/- 20 minutes). This will help to avoid hypoglycemia (low blood sugar).

Project the right attitude. Be careful that you don't contribute to your child's anxiety by making a big fuss about the injection. Don't be dramatic, apologetic, or overly sympathetic. Remain matter-of-fact and businesslike during the few minutes you spend giving the injection, and always give your child a big hug and words of praise afterward.

Talk it out. It may be helpful to pick a time when you're not giving an injection to talk with your child about any fears or worries. What goes through your child's mind when it's time to get the shot? Are there particular words or phrases your child tends to think about when feeling anxious? Try to come up with a substitute—a positive and helpful phrase or sentence your child can repeat to him or herself whenever anxious thoughts start to creep in.

Sing it out. Pick a song your child enjoys and sing it together during the injection. It should last the length of the injection time, and before both of you know it, the injection will be done.

Instructions For Use

Important Safety Information & Indication

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.

Click here to view Increlex® Full Prescribing Information and Patient Information.

Indication

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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