PLEASE SEE UPDATED FULL PRESCRIBING INFORMATION AND IMPORTANT SAFETY INFORMATION FOR INCRELEX

The testing process.

The procedures to expect.
The IGF-1 screening to ask for.

If you and your child's doctor have discussed short stature, and agree that it may require a more expert opinion, he or she will refer you to a specialist called a pediatric endocrinologist. And because arriving at an accurate diagnosis can be complex, it may take several trips to the specialist before a specific short stature disorder is diagnosed.

To reach a diagnosis, the doctor is likely to do the following things:

  • Measure your child
  • Ask questions about family history
  • Rule out the prospect of other conditions that might affect height, such as poor nutrition, underactive thyroid, or chronic treatment with steroids

After doing the above, your doctor may then

  • Conduct several blood tests to determine levels of growth hormone

IMPORTANT: Your doctor should be testing your child for both growth hormone and IGF-1 in order to reach an informed diagnosis. IGF-1 screening measures blood levels of IGF-1, which is an important hormone for growth. Don't be afraid to ask your child's doctor about IGF-1 screening during the diagnostic workup.

The GH stimulation test

Based on the result of your child's IGF-1 screening, your child may then be given a growth hormone stimulation test. The two results together will provide your doctor with a more complete picture from which to make an accurate diagnosis.

During a GH stimulation test

  • A sample of blood is drawn after your child has fasted for 10-12 hours.
  • Then, under close medical supervision, your child is given an intravenous solution (L-dopa or arginine), which stimulates the pituitary gland to produce growth hormone and has been known to make children feel sleepy or nauseous. You can help calm your child by assuring her that these are perfectly normal reactions and that they will not last long.
  • Next, blood samples are drawn at timed intervals and GH levels are tested. The entire process may take several hours. It's a good idea to prepare your child for a lengthy office visit and bring along reading material to make the time pass more quickly.
  • Responses to GH testing vary and interpreting results can be complex; thus, GH testing is not consistently reliable in determining if patients need GH therapy.

If IGF-1 is exceptionally low but GH is normal

If your child's growth hormone levels turn out to be normal or high but IGF-1 levels are exceptionally low, your doctor may diagnose your child as having severe primary IGFD. If your doctor already has performed a GH stimulation test on your child, talk to your doctor about IGF-1 screening.

If a GH stimulation test has been conducted but IGF-1 levels have not been checked

Your child's growth hormone levels tell only part of his or her growth story. Your child's IGF-1 levels should also be checked. IGF-1 levels are checked with a simple blood test. Be sure to talk to your child's doctor about obtaining an IGF-1 screening.

A checklist for parents—what you can do to help

  • Assure your child. To a child, having blood drawn can be scary. Remember to assure your child that the testing process doesn't last long and, more importantly, that it's necessary so that your child's doctors can figure out why he or she isn't growing properly.
  • Be aware of gender differences. A study discovered that significantly fewer girls than boys were referred to a specialist for further evaluation, likely due to social pressures that imply short stature is a more significant problem in boys than girls. There are many reasons that a child may have short stature, including underlying conditions such as celiac disease, so continue to advocate for your child, girl or boy, until you and the doctor are satisfied that an accurate diagnosis has been reached.
  • Ask about IGF-1 screening. Talk to your child's doctor about screening for IGF-1 deficiency. This is important for any child being tested and is especially important for those who have been taking growth hormone therapy and have not responded during 6 to 12 months of treatment. Remember: don't be afraid to talk to your child's doctor about IGF-1 screening. You both want what's best for your child and what's best begins with an accurate diagnosis.

Be an advocate for your child. Talk to your doctor about having your child screened for severe primary IGFD, and about a therapy that treats it, Increlex® (mecasermin) injection.

Learn more about INCRELEX

Important Safety Information

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.

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

Indication

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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