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GENOTROPIN is
indicated for the treatment of growth failure in
children born small for gestational age (SGA) who fail
to manifest catch-up growth by age 2 years.
GENOTROPIN is indicated for the
treatment of growth failure associated with Turner
syndrome.
GENOTROPIN is indicated for the
treatment of idiopathic short stature (ISS), also called
non-growth hormone-deficient short stature, defined by
height standard deviation score (SDS) <-2.25, and
associated with growth rates unlikely to permit
attainment of adult height in the normal range, in
pediatric patients whose epiphyses are not closed and
for whom diagnostic evaluation excludes other causes
associated with short stature that should be observed or
treated by other means.
1.2 Adult
Patients
GENOTROPIN is indicated for
replacement of endogenous growth hormone in adults with
growth hormone deficiency who meet either of the
following two criteria:
Adult Onset (AO): Patients who have
growth hormone deficiency, either alone or associated
with multiple hormone deficiencies (hypopituitarism), as
a result of pituitary disease, hypothalamic disease,
surgery, radiation therapy, or trauma; or Childhood
Onset (CO): Patients who were growth hormone deficient
during childhood as a result of congenital, genetic,
acquired, or idiopathic causes.
Patients who were treated with
somatropin for growth hormone deficiency in childhood
and whose epiphyses are closed should be reevaluated
before continuation of somatropin therapy at the reduced
dose level recommended for growth hormone deficient
adults. According to current standards, confirmation of
the diagnosis of adult growth hormone deficiency in both
groups involves an appropriate growth hormone
provocative test with two exceptions: patients with
multiple other pituitary hormone deficiencies due to
organic disease; and patients with congenital/genetic
growth hormone deficiency.
2 DOSAGE AND
ADMINISTRATION
The weekly dose should be divided
into 6 or 7 subcutaneous injections. GENOTROPIN must not
be injected intravenously.
Therapy with GENOTROPIN should be
supervised by a physician who is experienced in the
diagnosis and management of pediatric patients with
growth failure associated with growth hormone deficiency
(GHD), Prader-Willi syndrome (PWS), Turner syndrome
(TS), those who were born small for gestational age (SGA)
or Idiopathic Short Stature (ISS), and adult patients
with either childhood onset or adult onset GHD.
2.1 Dosing of
Pediatric Patients
General Pediatric Dosing Information
The GENOTROPIN dosage and
administration schedule should be individualized based
on the growth response of each patient.
Response to somatropin therapy in
pediatric patients tends to decrease with time. However,
in pediatric patients, the failure to increase growth
rate, particularly during the first year of therapy,
indicates the need for close assessment of compliance
and evaluation for other causes of growth failure, such
as hypothyroidism, undernutrition, advanced bone age and
antibodies to recombinant human GH (rhGH).
Treatment with GENOTROPIN for short
stature should be discontinued when the epiphyses are
fused.
Pediatric Growth Hormone Deficiency (GHD)
Generally, a dose of 0.16 to 0.24
mg/kg body weight/week is recommended.
Recent literature has recommended
initial treatment with larger doses of somatropin (e.g.,
0.48 mg/kg/week), especially in very short children
(i.e., height SDS <–3), and/or older/ pubertal children,
and that a reduction in dosage (e.g., gradually towards
0.24 mg/kg/week) should be considered if substantial
catch-up growth is observed during the first few years
of therapy. On the other hand, in younger SGA children
(e.g., approximately <4 years) (who respond the best in
general) with less severe short stature (i.e., baseline
height SDS values between -2 and -3), consideration
should be given to initiating treatment at a lower dose
(e.g., 0.24 mg/kg/week), and titrating the dose as
needed over time. In all children, clinicians should
carefully monitor the growth response, and adjust the
somatropin dose as necessary.
2.2 Dosing of
Adult Patients
Adult Growth Hormone Deficiency (GHD)
Either of two approaches to
GENOTROPIN dosing may be followed: a non-weight based
regimen or a weight based regimen.
Non-weight based — based on published
consensus guidelines, a starting dose of approximately
0.2 mg/day (range, 0.15-0.30 mg/day) may be used without
consideration of body weight. This dose can be increased
gradually every 1-2 months by increments of
approximately 0.1-0.2 mg/day, according to individual
patient requirements based on the clinical response and
serum insulin-like growth factor I (IGF-I)
concentrations. The dose should be decreased as
necessary on the basis of adverse events and/or serum
IGF-I concentrations above the age- and gender-specific
normal range. Maintenance dosages vary considerably from
person to person, and between male and female patients.
Weight based — based on the dosing
regimen used in the original adult GHD registration
trials, the recommended dosage at the start of treatment
is not more than 0.04 mg/kg/week. The dose may be
increased according to individual patient requirements
to not more than 0.08 mg/kg/week at 4–8 week intervals.
Clinical response, side effects, and determination of
age- and gender-adjusted serum IGF-I concentrations
should be used as guidance in dose titration.
A lower starting dose and smaller
dose increments should be considered for older patients,
who are more prone to the adverse effects of somatropin
than younger individuals. In addition, obese individuals
are more likely to manifest adverse effects when treated
with a weight-based regimen. In order to reach the
defined treatment goal, estrogen-replete women may need
higher doses than men. Oral estrogen administration may
increase the dose requirements in women.
2.3
Preparation and Administration
The GENOTROPIN 5 and 12 mg cartridges
are color-coded to help ensure proper use with the
GENOTROPIN Pen delivery device. The 5 mg cartridge has a
green tip to match the green pen window on the Pen 5,
while the 12 mg cartridge has a purple tip to match the
purple pen window on the Pen 12.
Parenteral drug products should
always be inspected visually for particulate matter and
discoloration prior to administration, whenever solution
and container permit.
GENOTROPIN MUST NOT BE INJECTED if
the solution is cloudy or contains particulate matter.
Use it only if it is clear and colorless.
GENOTROPIN may be given in the thigh,
buttocks, or abdomen; the site of SC injections should
be rotated daily to help prevent lipoatrophy.
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1 box of
36iu (12 mg)
In Stock
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