DOSAGE AND ADMINISTRATION
The Nutropin® [somatropin (rDNA origin) for
injection] dosage and administration schedule should be individualized
for each patient. Response to growth hormone therapy in pediatric
patients tends to decrease with time. However, in pediatric patients
failure to increase growth rate, particularly during the
first year of therapy, suggests the need for close assessment
of compliance and evaluation of other causes of growth failure, such as
hypothyroidism, under‑nutrition, and advanced bone
age.
Dosage
Pediatric Growth Hormone Deficiency (GHD)
A weekly dosage of up to 0.3 mg/kg of
body weight divided into daily subcutaneous injection is
recommended. In pubertal patients, a weekly dosage of up
to 0.7 mg/kg divided daily may be
used.
Adult Growth Hormone Deficiency (GHD)
Based on the weight-based dosing utilized in the
original pivotal studies described herein, the
recommended dosage at the start of therapy is not more
than 0.006 mg/kg given as a daily subcutaneous
injection. The dose may be increased according to
individual patient requirements to a maximum of 0.025
mg/kg daily in patients under 35 years old and to a
maximum of 0.0125 mg/kg daily in patients over
35 years old. Clinical response, side effects, and
determination of age- and gender-adjusted serum IGF-I
levels may be used as guidance in dose titration.
Alternatively, taking into account more recent
literature, 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 IGF-I concentrations. During therapy, the dose
should be decreased if required by the occurrence of
adverse events and/or serum IGF-I levels above the age-
and gender-specific normal range. Maintenance dosages
vary considerably from person to person.
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.
Chronic Renal Insufficiency (CRI)
A weekly dosage of up to 0.35 mg/kg of
body weight divided into daily subcutaneous injection is
recommended.
Nutropin therapy may be continued up to the time
of renal transplantation.
In order to optimize therapy for patients who
require dialysis, the following guidelines for injection
schedule are recommended:
- Hemodialysis patients should receive their
injection at night just prior to going to sleep or
at least 3–4 hours after their
hemodialysis to prevent hematoma formation due to
the heparin.
- Chronic Cycling Peritoneal Dialysis (CCPD)
patients should receive their injection in the
morning after they have completed dialysis.
- Chronic Ambulatory Peritoneal Dialysis (CAPD)
patients should receive their injection in the
evening at the time of the overnight
exchange.
Turner Syndrome
A weekly dosage of up to 0.375 mg/kg of
body weight divided into equal doses 3 to
7 times per week by subcutaneous injection is
recommended.
Idiopathic Short Stature (ISS)
A weekly dosage of up to 0.3 mg/kg of
body weight divided into daily subcutaneous injection
has been shown to be safe and efficacious, and is
recommended.
Administration
After the dose has been determined, reconstitute as
follows: each 5 mg vial should be reconstituted with
1–5 mL of Bacteriostatic Water for Injection,
USP (benzyl alcohol preserved); or each 10 mg vial
should be reconstituted with 1–10 mL of
Bacteriostatic Water for Injection, USP (benzyl alcohol
preserved), only. For use in newborns, see WARNINGS. The pH of Nutropin
after reconstitution with Bacteriostatic Water for Injection,
USP (benzyl alcohol preserved), is approximately 7.4.
To prepare the Nutropin solution, inject the
Bacteriostatic Water for Injection, USP (benzyl alcohol
preserved) into the Nutropin vial, aiming the stream of liquid
against the glass wall. Then swirl the product vial with a
GENTLE rotary motion
until the contents are completely dissolved. DO NOT SHAKE. Because Nutropin
is a protein, shaking can result in a cloudy solution. The
Nutropin solution should be clear immediately after
reconstitution. Occasionally, after refrigeration, you may
notice that small colorless particles of protein are present in
the Nutropin solution. This is not unusual for solutions
containing proteins. If the solution is cloudy immediately after
reconstitution or refrigeration, the contents MUST NOT be injected.
Before needle insertion, wipe the septum of both the
Nutropin and diluent vials with rubbing alcohol or an antiseptic
solution to prevent contamination of the contents by
microorganisms that may be introduced by repeated needle
insertions. It is recommended that Nutropin be administered
using sterile, disposable syringes and needles. The syringes
should be of small enough volume that the prescribed dose can be
drawn from the vial with reasonable accuracy.
STABILITY AND STORAGE
Before Reconstitution—Nutropin and Bacteriostatic Water
for Injection, USP (benzyl alcohol preserved), must be stored at
2–8°C/36–46°F (under
refrigeration). Avoid freezing the vials of
Nutropin and Bacteriostatic Water for Injection, USP (benzyl alcohol
preserved). Expiration dates are stated on the labels.
After Reconstitution—Vial contents are stable for
14 days when reconstituted with Bacteriostatic Water for
Injection, USP (benzyl alcohol preserved), and stored at
2–8°C/36–46°F (under
refrigeration). Avoid freezing the
reconstituted vial of Nutropin and the Bacteriostatic Water for
Injection, USP (benzyl alcohol preserved).
|