Prescribing Information | For Health Care Providers | Safety Information

Idiopathic Short Stature (ISS)

Condition Overview

Idiopathic Short Stature, or “ISS,” describes a growth problem in children. Children with ISS are shorter than those in the general population. Their height falls in the lowest 1.2% of all children in the United States of the same age and sex. That means that they are shorter than 98.8% of other children. Unfortunately, there is no known cause of ISS. Scientists are working to understand better why some kids have growth problems. They have made progress but still have not found a cause for growth failure in these children.

After birth, there are 3 standard phases of growth: infancy (birth to age 3), childhood (age 3 to age 8 or 9), and puberty (age 8 or 9 to age 13 or 14). During infancy, most children grow an average total of 17 inches. During childhood, most children grow an average of 2 inches per year. During puberty, most children grow an average of 2.5 inches to 3.5 inches per year.

Your doctor measures your child at each checkup and marks the chart. If your child’s growth is not keeping up with most other kids, there are tests that can show why. These tests include:

A full physical exam
Blood and urine tests to help rule out other disorders that could affect growth

If no other cause can be found, the child is said to have ISS and may benefit from growth hormone therapy.

If you want to know about the causes of slow growth, the ways it may affect your child, and how you can talk to your child's doctor about it, visit HealthyGrowth.com.

Next Section: About GENOTROPIN

Uninsured? Need help paying for medicine? Pfizer has programs that can help, no matter your age or income. You may even qualify for free Pfizer medicines. Call 1-866-706-2400. Click here for more info www.pfizerhelpfulanswers.com.

Deaths have been reported with the use of growth hormone in children with Prader-Willi syndrome. These children were extremely overweight, had breathing problems, and/or had a lung infection. All patients with Prader-Willi syndrome should be examined for these problems. They should also establish healthy weight control.

In studies of GENOTROPIN in children with PWS, side effects included fluid retention, aggressiveness, joint and muscle pain, hair loss, headache, and increased pressure in the brain.

Indications

GENOTROPIN^® (somatropin [rDNA origin] for injection) is a prescription product for the treatment of growth failure in:

children who do not make enough growth hormone on their own. This condition is called growth hormone deficiency (GHD).
children who were born smaller than most other babies born after the same number of weeks of pregnancy. Some of these babies may not show catch-up growth by age 2. This condition is called small for gestational age (SGA).
children with a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor.
girls with a genetic condition called Turner syndrome (TS). Growth hormone should be used to treat TS only in girls who are still growing.
children with idiopathic short stature (ISS), which means that they are shorter than 98.8% of other children of the same age and sex; they are growing at a rate that is not likely to allow them to reach normal adult height; and their growth plates have not closed. Other causes of short height should be ruled out. ISS has no known cause.

GENOTROPIN is a prescription product for the replacement of growth hormone in adults with growth hormone deficiency (GHD) that started either in childhood or as an adult. Your doctor should do tests to be sure you have GHD, as appropriate.

Important Safety Information

Growth hormone should not be used to increase height in children after the growth plates have closed.

Growth hormone should not be used in patients with diabetes who have certain types of diabetic retinopathy (eye problems).

Growth hormone should not be used in patients with cancer or who are being treated for cancer. Growth hormone deficiency can be caused by brain tumors. So, the presence of these brain tumors should be ruled out before treatment is started. Growth hormone should not be used if it is shown that a previous brain tumor has come back or is getting larger.

Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure.

Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems.

Other Safety Information

Dosage of diabetes medicines may need to be adjusted during growth hormone treatment. Patients should be watched carefully if growth hormone is given along with glucocorticoid therapy and/or other drugs that are processed by the body in the same way.

In childhood cancer survivors, treatment with growth hormone may increase the risk of a new tumor, particularly certain benign brain tumors. This risk may be higher in patients who were treated with cranial radiation.

A small number of patients treated with growth hormone have had increased pressure in the brain. This can cause headaches and problems with vision. Treatment should be stopped and reassessed in these patients. Patients with Turner syndrome and Prader-Willi syndrome may be at higher risk of developing increased pressure in the brain.

Thyroid function should be checked regularly during growth hormone therapy. Thyroid hormone replacement therapy should be started or adjusted if needed.

Patients treated with growth hormone should be checked regularly if they are receiving standard hormone replacement therapy to treat a lack of more than one hormone.

In children experiencing rapid growth, curvature of the spine may develop or worsen. This is also called scoliosis.

In children experiencing rapid growth, limping or hip or knee pain may occur.

GENOTROPIN should only be used during pregnancy if clearly needed. It should be used with caution in nursing mothers because it is not known whether growth hormone is present in human milk.

A different site should be used each day for growth hormone injections. This can help to prevent skin problems such as lumpiness or soreness.

A health care provider will help you with the first injection. He or she will also train you on how to inject GENOTROPIN.

Terms of Use Agreement

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider. All decisions regarding patient care must be made with a health care provider, considering the unique characteristics of the patient.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

Pfizer is a licensee of the TRUSTe Privacy Program.