PROTROPIN
Protropin 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 plus an additional amino acid. Recombinant
growth hormone was cloned by Genentech scientists in 1979.
Status
Genentech received FDA approval for Protropin in October
1985 for the long-term treatment of children who have
growth failure due to a lack of adequate endogenous
growth hormone secretion. It was Genentech's first commercial
product.
Disease Education
Growth hormone deficiency, GHD, is a pituitary disorder
resulting in short stature. GHD occurs when the production
of growth hormone, secreted by the pituitary gland,
is disrupted.
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, or in patients
with active neoplasia. Growth hormone should be discontinued
if evidence of neoplasia develops.
Intracranial hypertension (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 being treated with growth hormone and/or their
parents should be informed of the potential benefits
and risks associated with Growth Hormone therapy. Please
see the full prescribing information for additional
patient conditions in which the risks of growth hormone
therapy may be increased.
PROTROPIN
PROTROPIN