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GENOTROPIN and Device Support

Is GENOTROPIN^® (somatropin [rDNA origin] for injection) safe?
How many children have been treated with GENOTROPIN?
Does GENOTROPIN come in pill form?
How does my child take GENOTROPIN?
Will the injections hurt?
Can GENOTROPIN be taken with other medications?
How many devices are available for GENOTROPIN, and what are some of the key differences?
Which device is right for my child?
I cannot find the information sheets for my injection device. Where can I get another copy of the product details or the Instructions for Use?
What does the needle guard do?
Can I use GENOTROPIN with standard syringes?
Can GENOTROPIN cause any side effects?
Who should NOT use GENOTROPIN?

Is GENOTROPIN safe?

GENOTROPIN has been used for over 20 years. It's been used to treat thousands of children and adults worldwide.

How many children have been treated with GENOTROPIN?

Over 60,000 children in more than 50 countries have used GENOTROPIN.

Does GENOTROPIN come in pill form?

GENOTROPIN does not come in a pill because it does not work when taken by mouth. Injecting GENOTROPIN lets the growth hormone stay active and help your child grow.

How does my child take GENOTROPIN?

GENOTROPIN is taken by injection just below the skin. A doctor or nurse will help you with the first injection. He or she will also train you on how to inject GENOTROPIN.

Will the injections hurt?

Your child will probably feel a little pinch. Also, the needle is very short and thin to help reduce the pain.

Can GENOTROPIN be taken with other medications?

GENOTROPIN can be taken with most other medications. But your doctor who specializes in growth issues can tell you for sure. Growth hormone (GH) therapy should not be used in patients with cancer or who are receiving cancer treatment. It should also not be started in patients who are ill because of surgery, trauma, or respiratory failure.

Be sure to tell your child's doctor about any drugs he or she is taking.

How many devices are available for GENOTROPIN, and what are some of the key differences?

GENOTROPIN offers 3 different devices to fit your lifestyle. Each offers special features.

The GENOTROPIN Pen^® is convenient and easy to learn and use,* and can be customized with Geno-Caps^®
The GENOTROPIN MiniQuick^® is the only single-use, prefilled device that does not require refrigeration. It contains no preservatives, and it's also portable, small, and easy to use*
The GENOTROPIN Mixer^® features internal mixing, is reusable, and can be used with standard syringes

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

Which device is right for my child?

The right device can make it easier to manage growth hormone (GH) therapy. The devices for GENOTROPIN were created to keep therapy simple and ensure accurate and consistent dosing. You can learn more about each device here. After you've learned about which device seems right for you, speak with your doctor. If you have any questions about the devices, call the Pfizer Bridge Program^® at 1-800-645-1280.

I cannot find the Instructions for Use for my injection device. Where can I get another copy of the Product Details or the Instructions for Use?

Choose the name of the device for which you would like to download and print a copy of the information sheet:

What does the needle guard do?

Both the GENOTROPIN Pen and the GENOTROPIN MiniQuick offer an optional needle guard. The needle guard hides the needle and keeps the pen stable during injection.

Can I use GENOTROPIN with standard syringes?

The GENOTROPIN Mixer is a reusable mixing device for use with 5-mg or 12-mg GENOTROPIN color-coded cartridges and standard syringes. You can read
more about this device.

Can GENOTROPIN cause any side effects?

Along with its benefits, any medical treatment may cause unwanted effects.

Pediatric GHD specific
In studies of GENOTROPIN in children with growth hormone deficiency (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
SGA specific
In studies of GENOTROPIN in children born small for gestational age (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)
PWS specific
Deaths have been reported with the use of growth hormone in children with Prader-Willi syndrome (PWS). These children were extremely overweight, had breathing problems, and/or lung infection. All patients with PWS 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.
TS specific
Turner syndrome (TS) 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 TS, side effects included flu, throat, ear, or sinus infection, runny nose, joint pain, and urinary tract infection.
ISS specific
In studies of GENOTROPIN in children with idiopathic short stature (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.
Adult specific
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.

Along with its benefits, any medical treatment may cause some unwanted effects. In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation.

This does not mean that you will have any of these reactions. It’s just that they are possible, based on reactions some people have had.
Tell the doctor about these or any other side effects that you notice.

Who should NOT use GENOTROPIN?

Growth hormone (GH) therapy should not be used in patients with cancer or who are receiving cancer treatment. It should also not be started in patients who are ill because of surgery, trauma, or respiratory failure.

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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.

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