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Nutropin®:
Nutropin is produced by Genentech using recombinant DNA technology
and has the same amino acid sequence as human growth hormone
produced naturally in the human body. Recombinant growth hormone
was cloned by Genentech scientists in 1979.
ABOUT
ADULT GROWTH HORMONE DEFICIENCY
Growth hormone (hGH or GH) doesn't just contribute to physical
growth in children. Adults need GH, too. In adults, GH is
essential to the maintenance of healthy body composition and
metabolism. When an adult's body is unable to produce enough
GH, he or she is said to have adult GH deficiency (AGHD).
Some
people with adult growth hormone (hGH or GH) deficiency were
not GH-deficient as children. These people are said to have
adult-onset GH deficiency.
The
usual cause of adult-onset GH deficiency is damage to the
pituitary gland, which is responsible for secreting GH. This
damage is most commonly caused by one or more tumors in and
around the pituitary. Such a tumor may compress the gland,
or the damage may occur when the tumor is removed. The pituitary
gland may also be damaged by infection, blood vessel disease,
severe head injury, or radiation treatment for tumors of the
head or neck. .
Disease
Education
Growth hormone deficiency, GHD, is a pituitary disorder resulting
in short stature and other physical ailments. GHD occurs when
the production of growth hormone, secreted by the pituitary
gland, is disrupted. Since growth hormone plays a critical
role in stimulating body growth and development, and is involved
in the production of muscle protein and in the breakdown of
fats, a decrease in the hormone affects numerous body processes.
Turner
syndrome affects approximately one in 2,500 female, live births.
Turner syndrome is a chromosomal disorder that affects females
exclusively and is characterized, in part, by short stature
and ovarian dysfunction. It is caused by the absence of all
or part of one of the X chromosomes.
Chronic renal insufficiency, CRI, affects about 3,000 children
in the United States. It manifests through a gradual and progressive
loss of the ability of the kidneys to excrete wastes, concentrate
urine, and conserve electrolytes. Kidney transplants can help
a child start growing normally again, but most children do
not make up the growth lost prior to transplantation.
Safety
Growth hormone should not be initiated to treat patients with
acute critical illness due to complications following open
heart or abdominal surgery, multiple accidental trauma or
to patients having acute respiratory failure.
Growth
Hormone should not be used for growth promotion in pediatric
patients with closed epiphyses.
Growth Hormone should not be used in patients with active
neoplasia. Growth Hormone therapy should be discontinued if
evidence of neoplasia develops. Patients with a history of
an intracranial lesion should be examined frequently for progression
or recurrence of the lesion.
Intracranial
hypertension (IH) with papilledema, visual changes, headache,
nausea, and/or vomiting has been reported in a small number
of patients treated with Growth Hormone. Funduscopic examination
of patients is recommended at the initiation and periodically
during Growth Hormone therapy. Patients with CRI or Turner's
Syndrome may be at increased risk for development of IH.
Growth
Hormone may reduce insulin sensitivity, particularly in obese
individuals, patients should be observed for evidence of glucose
intolerance. For patients with diabetes mellitus, the insulin
dose may require adjustment when Growth Hormone therapy is
instituted.
Experience
with prolonged Growth Hormone treatment in adults is limited.
Adverse events frequently reported in adult patients were
edema (41%), arthralgias and other joint disorders (27%).
Thirty-five percent of childhood-onset adult Growth Hormone
deficient subjects treated with Growth Hormone 0.025 mg/kg/day
for 2 years had supraphysiologic levels of insulin-like growth
factor-I (IGF-I) at some time during the study, which may
carry unknown risks. During therapy, dosage should be decreased
if required by the occurrence of side effects or excessive
IGF-I levels.
Patients
being treated with Growth Hormone (GH) should be informed
of the potential benefits and risks associated with Growth
Hormone therapy.
For
additional product Information
visit: www.nutropin.com
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