Important Safety Information
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:
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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 prescribed for the treatment of growth failure in adults.
GENOTROPIN is prescribed for 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.
Contraindications
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
a will also train you on how to inject GENOTROPIN.
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