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

Give support. Get support.

  • Maintain a positive attitude. Be patient and be sure to support your child at all times
  • Seek out a mentor, or other parents who've been through the treatment, for support; the doctor's office may be a good source
  • Check out parent support groups and online discussion boards

Spend time on websites that offer information and support

The Magic Foundation for children's growth is an American nonprofit organization. It helps families of children diagnosed with a wide variety of different growth-impacting medical conditions through education, networking, physician referrals, and many other services. “MAGIC” stands for Major Aspects of Growth In Children.

Little People of America (LPA) is a nonprofit organization that provides support and information to people of short stature and their families. It offers peer and parent support, medical resources and referrals, scholarships, and programs that benefit the people of the short stature community. It also promotes education, community outreach, personal and family strength, and life achievements.

Find strength within yourself

There may be days when your child is afraid of being teased at school, scared about their treatment, or frustrated if growth doesn't happen overnight. As a parent, you may have your own frustrations and anxieties.

Remind yourself that you've been a successful advocate for your child and are taking positive steps to help your child. Let your child know how confident you feel about treatment, and celebrate the gains along the way with a fun outing or treat, a celebratory dinner, or hugs and lots of praise. Feel free to pat yourself on the back, too, for getting your child this far.

Follow-up is important

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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