Prescribing Information | For Health Care Providers | Safety Information

Side Effects and Safety

GENOTROPIN^® (somatropin [rDNA origin] for injection) has been used for over 20 years. It has been used to treat thousands of people worldwide. Over 60,000 children in more than 50 countries have safely used GENOTROPIN. However, along with its benefits, any medical treatment may cause some 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 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 specific

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.

Adult specific

Women who are taking estrogen by mouth may need a larger dose of growth hormone. Eldery 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.

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

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. Your doctor who specializes in growth issues will decide if GENOTROPIN is right for your child. You should feel free to discuss any concerns you may have about your child's treatment with his or her doctor.

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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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