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Important Safety Information
Indications
GENOTROPIN® (somatropin [rDNA origin] for injection) is prescribed 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 are born smaller than most 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.
Other causes of short height should be ruled out.
- 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 eye problems called diabetic retinopathy.
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
The dose 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.
Treatment with growth hormone may increase the risk of a new tumor, particularly certain benign brain tumors, in childhood cancer survivors. 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, Prader-Willi syndrome, and chronic renal insufficiency 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.
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