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Glossary

Bone age:

A way to measure how old a bone is. It helps doctors tell more about a person's growth potential.

Catch-up growth:

Faster-than-average growth rate in a small child.

Chromosome:

A structure in the cell nucleus that carries hereditary characteristics. There are 23 pairs of chromosomes in humans.

cm:

Stands for centimeter in the metric system. One centimeter is almost half an inch. It is used to measure growth.

Diluent:

A liquid used to dissolve a drug to be injected.

DNA (deoxyribonucleic acid):

DNA is found in the chromosomes of animal and vegetable cells. It is responsible for what a person inherits.

Endocrine:

Having to do with hormones.

Endocrinology:

The study of the endocrine system.

Epiphysis (plural: epiphyses):

The part of a long bone that grows.

Familial short stature:

Short children of short parents.

FDA (Food and Drug Administration):

The FDA is part of the United States Department of Health and Human Services with responsibility to regulate the safety of medicines.

Genes:

The basic biological units that are passed on from one generation to the next. Genes control what a person inherits, such as height and hair color.

Growth chart:

A record of the height and weight of a person.

Hypopituitarism:

A deficiency of one or more hormones made in the pituitary gland.

Injection site:

A place on the body where a medicine is injected under the skin or into muscle with a needle. Growth hormone therapy is injected under the skin of the thigh, buttock, or abdomen. A different injection site should be used each day.

kg:

Stands for kilogram in the metric system. One kilogram is equal to 2.2 pounds.

Lyophilized powder:

Freeze-dried powder.

mL:

Stands for milliliter in the metric system. Five (5) mL is about 1 teaspoon.

Patient Care Consultant (PCC):

A specialist at the Pfizer Bridge Program. The PCC provides reimbursement support and can help access device support for patients on GENOTROPIN (somatropin [rDNA origin] for injection) and their families throughout treatment. Your PCC works with you, your doctor's office, your health insurance company, and your pharmacy while you or your child are being treated.

Percentile:

A term doctors use to compare a child's height and weight with those of other children.

Pfizer Bridge Program:

Pfizer Bridge Program

The Pfizer Bridge Program offers insurance coverage and device support for you and your child throughout treatment. With the Pfizer Bridge Program, you will be assigned a Patient Care Consultant (PCC). This means you will have access to the same person who knows you or your child's treatment history.

Pituitary gland:

A small gland in the brain that secretes growth hormone. It secretes other hormones as well.

Pre certification:

A process used by your health insurance providers to decide whether or not they will cover the cost of the procedure or drug prescribed by a physician.

Puberty:

Changes that happen to children as they become adults. At this time there is a growth spurt that lasts about 2 years. It is marked by sexual development—growth of pubic hair and development of sex organs. Females begin to menstruate during this time.

rDNA:

This stands for recombinant DNA. It is the result of combining genetic materials of different origins.

Reconstitution:

A return to the original state of a substance.

Replacement therapy:

A treatment program that will give a person what their bodies do not adequately produce. Growth hormone replacement therapy (for example, GENOTROPIN) is used because the body does not secrete enough of its own growth hormone.

Small for gestational age (SGA):

A birth weight, birth length, or both that is below the third percentile, after adjustment for gestational age and sex.

Somatropin:

Natural growth hormone. It is a protein that is secreted by the pituitary gland.

Stadiometer:

A device used to measure height.

Statement of Medical Necessity (SMN):

A form a doctor fills out that explains why a therapy has been recommended. This document acts as a prescription for growth hormone (GH) therapy.

"Stim" test (stimulation test):

This test will "stimulate" the production of growth hormone.
It will help your child's doctor decide if he or she is making enough growth hormone. During the test, one or more medicines may be given to your child. Some will be given by injection or IV needle. During the test, samples of blood will be taken so the doctor can measure how the growth hormone in your child's body is responding.

Systemic:

Affecting the whole body.

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Important Safety Information and Indications

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.
GENOTROPIN should not be used by patients who have had an allergy or bad reaction to somatropin or any of the other ingredients in GENOTROPIN.
Some patients have developed diabetes mellitus while taking GENOTROPIN. 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. Also, patients and their doctors should check regularly for any skin changes.
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. Patients with scoliosis should be checked regularly to make sure their scoliosis does not get worse during their growth hormone therapy.
In children experiencing rapid growth, limping or hip or knee pain may occur. If a child getting growth hormone therapy starts to limp or gets hip or knee pain, the child’s doctor should be notified and the child should be examined.
Growth hormone 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 passed into human milk.
Use a different place on the body each day for growth hormone injections. This can help to prevent skin problems such as lumpiness or soreness.
Some cases of pancreatitis (inflamed pancreas) have been reported rarely in children and adults receiving growth hormone. There is some evidence that there is a greater risk of this in children than in adults. Literature suggests that girls who have Turner syndrome may have a greater risk of pancreatitis than other children taking growth hormone. In any child who develops lasting, severe abdominal pain, pancreatitis should be considered.
In studies of GENOTROPIN in children with GHD, side effects included injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash. Other side effects were fat loss, headache, blood in the urine, low thyroid activity, and mildly increased blood sugar.
In studies of GENOTROPIN in children born SGA, side effects included temporarily elevated blood sugar, increased pressure in the brain, early puberty, abnormal jaw growth, injection site reactions, growth of moles, and worsening of scoliosis (curvature of the spine).
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 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.
Turner syndrome patients taking growth hormone therapy may be more likely to get ear infections. This is also called otitis media.
In studies of GENOTROPIN in children with Turner syndrome, side effects included flu, throat, ear, or sinus infection, runny nose, joint pain, and urinary tract infection.
In studies of GENOTROPIN in children with ISS, side effects included respiratory illnesses, flu, throat infection, inflammation of the nose and throat, stomach pain, headaches, increased appetite, fever, fracture, mood changes, and joint pain.
Women who are taking estrogen by mouth may take GENOTROPIN. They may need a larger dose of growth hormone
GENOTROPIN may be taken by the elderly. Elderly patients may be more likely to have side effects with growth hormone therapy.
In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation. Usually these side effects did not last long and depended on the dose of GENOTROPIN being taken.
GENOTROPIN cartridges contain m-Cresol and should not be used by patients allergic to it.
A health care provider will help you with the first injection. He or she will also train you on how to inject GENOTROPIN.

Rx only

Indications

GENOTROPIN 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).
With a genetic condition called Prader-Willi syndrome (PWS). Growth hormone is not right for all children with PWS. Check with your doctor.
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 years. This condition is called small for gestational age (SGA).
With a genetic condition called Turner syndrome (TS).
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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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

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