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Severe Primary IGF-1 Deficiency support and information

Learn about the IPSEN CARES® support program and download the patient information booklet on starting and staying on treatment with INCRELEX®. You can also find links to useful online resources to help you when you start your INCRELEX® treatment journey.

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IPSEN CARES®

IPSEN CARES® is a comprehensive support program designed to help you access the medications and services that you need. The program is designed to serve as a central point of contact between you, your child’s physician, insurance companies, and specialty pharmacies.

For more information, please call 1-866-435-5677 Monday-Friday 8am-8pm ET (5 am-5 pm PT) or visit the IPSEN CARES® website.

The MAGIC Foundation

The MAGIC [Major Aspects of Growth In Children] Foundation for children’s growth is an American nonprofit organization. The Foundation helps families of children diagnosed with growth-impacting medical conditions through education, networking, and many other services.

The Human Growth Foundation

The Human Growth Foundation is an American nonprofit organization that is actively involved in patient advocacy, endocrine research, and provides family education and support on growth disorders and their treatment. The Foundation’s vision includes helping children with growth disorders and their healthcare providers by increasing awareness and the importance of early diagnosis and treatment.

International Children’s Growth Awareness Day

The International Children’s Growth Awareness Day is held on the 20th September every year and is when organizations around the world unite to promote and educate about the importance of annual growth checks for children. Growth Awareness Day is an initiative of the International Coalitions of Organizations Supporting Endocrine Patients (ICOSEP).

INCRELEX® Information

INCRELEX® Information

Each Child is Unique – Patient Education Brochure

This brochure provides information about INCRELEX® for those who are starting their

IGF-1 treatment journey. It provides details of how INCRELEX® works to help children grow and how their treatment needs to be determined based on their age, weight, and height, among other factors, such as tolerability.

The brochure provides a practical means for you to record your child’s growth progress, and space to note any questions that you may wish to ask during follow-up appointments. Important safety information about INCRELEX® treatment is included, as is information about the IPSEN CARES® support program.

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Tips on How to Give an Increlex® Injection

Important things about administering Increlex

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What to expect when administering Increlex®

Some helpful information on the possible side effects of Increlex and ways to help manage them.

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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 maybe 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 the 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 for your child 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.

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INCRELEX® is a registered trademark of Ipsen Biopharmaceuticals, Inc. IPSEN CARES is a registered trademark of Ipsen S.A

© 2020 Ipsen Biopharmaceuticals, Inc. All rights reserved. November 2020 INC-US-001015