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Staying on treatment with INCRELEX®

INCRELEX® dosing is dependent on many factors, such as tolerability and a child's weight and height. Regular weight monitoring throughout treatment is important for appropriate dosing.

Talk to your doctor about the growth expectations for your child while on INCRELEX® treatment.

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How to Inject Increlex

How to Inject Increlex

Watch this video to find out how to prepare and inject the correct dose of Increlex

Goal of Treatment

Goal of Treatment

Working with your child’s doctor to find the right treatment is very important in helping manage Severe Primary insulin-like growth factor-1 (IGF-1) Deficiency.

There is a window of time when your child is able to grow. Once your child enters the teen years, the potential to grow slows – and eventually stops – when the growth plates (epiphyses) close.

What to Expect

What to Expect with INCRELEX®

It is important to have realistic expectations of treatment with INCRELEX®, as changes to your child’s height may take time to be apparent.

GROWTH RATE WITH INCRELEX® OVER 8 YEARS3*

Growth rate chart

*Data comes from a clinical trial with 71 children with severe primary IGF-1 deficiency, Children aged > 2 years of age were eligible to enroll in the study. The mean age for these patients at baseline (before treatment) was: 7.8 years ± 4.5 years. The rate of growth pre-treatment (referred to as pretreatment height velocity) was available and is shown above for 58 patients. N is the number of patients evaluated for each year of therapy.

Results:

The average rate of growth (referred to as height velocity) increased by 8 cm per year in the first year from a baseline of 2.8 cm per year. The increase in height from year 1 compared to baseline was statistically significant (P < 0.0001).

The average rate of growth (referred to as height velocity) sustained by 5 cm per year in years 2 through 6 of treatment.

Patients experienced increased rate of height growth without increasing the rate of chronological bone age. Bone age is used to categorize the degree of skeletal maturation.

*Forty-nine subjects were included in an analysis of the effects of Increlex on the way your child’s bone changes in size and shape (referred as bone age). The mean ± SD change in chronological age was 4.9 ± 3.4 years and the mean ± SD change in bone age was 5.3 ± 3.4 years.

In clinical trials, INCRELEX® improved statural growth in patients diagnosed with Severe Primary IGFD

The response to INCRELEX® will vary from child to child.

You can help your doctor by regularly measuring your child’s height and monitoring their weight. Discuss with the doctor any changes to your child’s height and weight, as these will help to determine whether the dose of INCRELEX® needs to be changed.

What to Know About INCRELEX® Dose Adjustment

Regular weight monitoring and tolerability are critical for correct INCRELEX® dosing. Talk to your child’s doctor if their weight has changed so that they can determine the correct dose of 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 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