What
is Saize®?
Saizen ®, or somatropin (rDNA), is a synthetic hormone identical
to human growth hormone. Man-made growth hormone may be used
in children who have certain conditions that cause failure to
grow normally. These conditions include growth hormone deficiency
(inability to produce enough growth hormone), kidney disease,
Prader-Willi Syndrome (PWS), and Turner's syndrome. Growth hormone
is also used in adults to treat growth failure and to treat
weight loss caused by acquired immunodeficiency syndrome (AIDS).
How
do I take Saizen®?
Saizen ® rx drugs are given as a subcutaneous injection
in the arm, leg, or abdomen. Reconstitute each vial with bacteriostatic
water for injection as directed. Do not shake. Do not inject
if the solution is cloudy or hazy. Unreconstituted Saizen ®
rx drugs should be stored at room temperature (59°-86°F).
After reconstitution, however, Saizen ® should be kept refrigerated.
When refrigerated, the reconstituted Saizen ® rx drugs is
stable for 14 days.
Average
dosages are as follows:
For treatment of growth failure caused by kidney disease:
Children-Dose is based on body weight and must be determined
by your doctor. The usual total weekly dose is 0.35 mg per kg
(0.16 mg per pound) of body weight. This is divided into smaller
daily doses and is injected under the skin or into a muscle.
- For
treatment of growth failure caused by Turner's syndrome:
Children-Dose is based on body weight and must be determined
by your doctor. The usual total weekly dose is 0.375 mg per
kg (0.17 mg per pound) of body weight. This is divided into
smaller doses and is injected under the skin.
- For
treatment of growth failure caused by Prader-Willi syndrome:
Children-Dose is based on body weight and must be determined
by your doctor. The usual total weekly dose is 0.24 mg per
kg (0.11 mg per pound) of body weight. This is divided into
6 or 7 smaller doses over the course of the week and is injected
under the skin.
- For
treatment of growth failure caused by growth hormone deficiency:
Adults-Dose is based on body weight and must be determined
by your doctor. At first, it is usually 0.006 milligram (mg)
per kilogram (kg) (0.0027 mg per pound) of body weight injected
under the skin once a day. Your doctor may then increase the
dose if needed.
Children-Dose
is based on body weight and must be determined by your doctor.
The usual total weekly dose is 0.16 to 0.3 mg per kg (0.073
to 0.136 mg per pound) of body weight. This is divided into
smaller doses and usually is injected under the skin, but
may be injected into a muscle as determined by your doctor.
Children using Norditropin Cartridges-Dose is based on body
weight and must be determined by your doctor. The usual dose
is 0.024 to 0.034 mg per kg (0.011 to 0.015 mg per pound of
body weight) injected under the skin, on 6 to 7 days a week.
The dose is given using a Nordipen™ injection device.
- For
treatment of weight loss caused by acquired immunodeficiency
disease (AIDS):
Adults weighing more than 121 pounds (55 kg)-6 mg injected
under the skin once a day at bedtime.
Adults weighing 99 to 121 pounds (45 to 55 kg)-5 mg injected
under the skin once a day at bedtime.
Adults weighing 77 to 98 pounds (35 to 44 kg)-4 mg injected
under the skin once a day at bedtime.
Adults weighing less than 77 pounds (35 kg)-Dose is based
on body weight and must be determined by your doctor. It is
usually 0.1 mg per kg (0.045 mg per pound) of body weight
injected under the skin once a day at bedtime.
Children-Use and dose must be determined by your doctor.
WHAT
DRUGS INTERACT WITH SAIZEN ®?
Before using Saizen ® rx drugs, tell your doctor if you
have ever had an allergic reaction to any rx drugs, if you are
currently taking any other prescription or non-prescription
rx drugs or if you have diabetes or hypothyroidism. Diabetic
patients may experience a change in glucose tolerance.
WHAT
ARE THE POTENTIAL SIDE AFFECTS OF SAIZEN ®?
Leukemia has been reported in a few patients after treatment
with growth hormone. However, it is not definitely known whether
the leukemia was caused by the growth hormone. Leukemia has
also been reported in patients whose bodies do not make enough
growth hormone and who have not yet been treated with man-made
growth hormone. However, discuss this possible side effect with
your doctor.
Check with your doctor as soon as possible if any of the following
side effects of Saizen ® rx drugs occur: ear infection or
other ear problems (in patients with Turner's syndrome), abdominal
pain or bloating; changes in vision; depression of skin at place
of injection ; headache; limp; nausea and vomiting; pain and
swelling at place of injection; pain in hip or knee; skin rash
or itching. Other side effects may occur that usually do not
need medical attention. These side effects may go away during
treatment as your body adjusts to the medicine. However, check
with your doctor if any of the following side effects continue
or are bothersome: carpal tunnel syndrome; enlargement of breasts;
increased growth of birthmarks; joint pain; muscle pain; swelling
of hands, feet, or lower legs; unusual tiredness or weakness.
IMPORTANT:
If Saizen ® rx drugs is used by children or adults with
normal growth, who do not need growth hormone, serious unwanted
effects may occur because levels in the body become too high.
These effects include the development of diabetes; abnormal
growth of bones and internal organs such as the heart, kidneys,
and liver; atherosclerosis (hardening of the arteries); and
hypertension (high blood pressure). ?
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