HGH
- Human Growth Hormone
GENOTROPIN®:
 |
Growth
hormone affects many parts of the body, including
the bones, muscles, and fat. Children need
growth hormone to grow taller. Adults also
need growth hormone to maintain health. When
the body does not produce enough of this hormone,
growth hormone deficiency (GHD) occurs |
GENOTROPIN® is
human growth hormone replacement therapy that can
be used to help compensate for low levels of growth
hormone. GENOTROPIN® is exactly like the natural
growth hormone produced by the body's pituitary gland.
Growth
hormone deficiency (GHD) in adults and growth failure
in children. Find out more about the symptoms, diagnosis,
and treatment of these conditions, along with general
information about GENOTROPIN® and delivery devices
for GENOTROPIN®.
Approved
Uses
GENOTROPIN® Lyophilized Powder (somatropin [rDNA origin] for injection)
is indicated for:
Pediatric Indications.
- Long-term
treatment of children who have growth failure due
to an inadequate secretion of endogenous growth
hormone (GH).
- Long-term
treatment of growth failure in children born small
for gestational age (SGA) who fail to manifest
catch-up growth by age 2.
- Long-term
treatment of children who have growth failure due
to Prader-Willi syndrome (PWS). The diagnosis of
PWS should be confirmed by appropriate genetic
testing.
Other causes of short stature in children should be excluded.
Adult Indications
- Long-term
replacement therapy in adults with growth hormone
deficiency (GHD) of either childhood- or adult-onset
etiology. GHD should be confirmed by a special
growth hormone test called a stimulation test.
Safety
Contraindications
Growth hormone (GH) should not be used in patients with active tumors or
receiving antitumor therapy. GH should not be used to increase height
in children with bones with closed growth plates.
GH should not be started to treat patients with critical illness due to complications
of surgery, injury, or respiratory failure. The safety of continuing GH replacement
therapy for approved uses in patients who develop these illnesses has not
been established.
Growth
hormone is contraindicated in patients with PWS who
are severely obese or have severe respiratory impairment.
Additional
Safety Information
Tell the doctor if the patient has any allergies to a preservative called
cresol, because the 5.8 mg and 13.8 mg cartridge strengths of GENOTROPIN® contain
this substance.
Deaths
have been reported with the use of growth hormone
in pediatric PWS patients with severe obesity, history
of respiratory impairment or sleep apnea, and/or
unidentified respiratory infection. Therefore, all
patients with PWS should be evaluated and monitored
for sleep apnea and respiratory infections, and have
effective weight control.
Insulin
dosage may need to be adjusted during therapy with
GH if the patient has diabetes. Dosages of other
medications also may need adjustment, so be sure
to tell the doctor about any medications the patient
may be taking.
GH
should be used during pregnancy only if clearly needed
and with caution in nursing mothers because it is
not known whether GENOTROPIN® is excreted in
human milk.
Children with disorders such as growth hormone deficiency have a higher rate
of slipped growth plates in the hip. Therefore, it is important to tell the
doctor if the patient begins to limp or complains of hip or knee pain during
GH therapy.
In children experiencing rapid growth, curvature of the spine may worsen.
The doctor may check the patient for spine curvature during GH therapy.
In
a small number of patients treated with growth hormone
products, intracranial hypertension, or IH (increased
pressure in the brain) has been reported. Symptoms
usually occurred within the first 8 weeks of therapy — in
all reported cases, signs/symptoms went away after
stopping therapy or reducing the dose. Do not change
GH dose without consulting your doctor. Be sure to
tell the doctor if symptoms such as headache, visual
changes, nausea and/or vomiting occur. Patients with
PWS may be at increased risk for IH.
In
studies with GENOTROPIN® in children with growth
hormone deficiencies, side effects included injection-site
reactions including pain or burning associated with
the injection, redness/swelling, scarring, lumps,
or rash; headache; blood in the urine; low thyroid
activity; and mildly increased blood sugar.
In
studies with GENOTROPIN® in children with PWS,
side effects included swelling from water/fluid retention,
aggressiveness, joint pain, intracranial hypertension,
or IH (increased pressure in the brain), hair loss,
headache, and muscle pain.
In
clinical studies of 273 pediatric patients born SGA
treated with GENOTROPIN®, the following side
effects were reported: mild temporary increased blood
sugar; increased pressure in the brain; early puberty;
jaw prominence; aggravation of pre-existing back
curvatures; injection-site reactions; and progression
of pigmented moles or birthmarks.
In
studies with GENOTROPIN® in adults with GHD,
the majority of side effects were mild to moderate
symptoms of water/fluid retention including swelling
of the hands or feet, stiffness of the extremities,
joint or muscle pain, and numbness and tingling in
the extremities. These side effects were reported
early in therapy and tended to be temporary and/or
helped by a dosage reduction.
Tell your doctor about these or any other side effects that you notice.
Please
click here for additional Genotropin Product
Information. or visit: www.genotropin.com
