A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Serostim Indications, Dosage, Storage, Stability - Somatropin (rDNA origin)
Serostim Indications, Dosage, Storage, Stability - Somatropin (rDNA origin)
INDICATIONS
AND USAGE
Serostim® [somatropin (rDNA origin) for injection]
is indicated for the treatment of AIDS wasting or cachexia. This indication
is based on analyses of surrogate endpoints in studies of up to 12 weeks in
duration. For patients treated in open-label extension studies, no significant
additional efficacy was observed beyond 12 weeks. There are no data available
from controlled studies for patients that start, stop, and re-start treatment.
Concomitant anti-viral therapy is necessary (see PRECAUTIONS:
GENERAL). The continued use of Serostim® treatment should be
reevaluated in patients who continue to lose weight in the first two weeks of
treatment.
DOSAGE AND ADMINISTRATION
Serostim® [somatropin (rDNA origin) for injection]
should be administered subcutaneously daily at bedtime according to the following
dosage recommendations:
|
Weight Range
|
Dose*
|
|
>55 kg
|
6 mg SC daily
|
|
45-55 kg
|
5 mg SC daily
|
|
35-45 kg
|
4 mg SC daily
|
* Based on an approximate daily dosage of 0.1 mg/kg.
In patients who weigh less than 35 kg, Serostim®
should be administered at a dose of 0.1 mg/kg subcutaneously daily at bedtime.
Serostim® 8.8 mg with Bacteriostatic Water for Injection, USP
(0.9 % Benzyl Alcohol) should be administered at a dose of 0.1 mg/kg subcutaneously
at bedtime.
Dose reductions for side effects felt to be related to treatment
with Serostim®, which are unresponsive to symptomatic treatment,
may be effected by reducing the total daily dose or the number of doses given
per week.
In patients who continue to lose weight at week 2, reevaluate
for concurrent opportunistic infections or other clinical events. Injection
sites should be rotated.
Safety and effectiveness in pediatric patients with AIDS have
not been established.
Each vial of Serostim® 4 mg, 5 mg or 6 mg is
reconstituted with 0.5-1 mL Sterile Water for Injection, USP. Each vial of Serostim®
8.8 mg is reconstituted in 1 mL to 2 mL of Bacteriostatic Water for Injection,
USP (0.9% Benzyl Alcohol preserved). For patients sensitive to this diluent
see "WARNINGS".
To reconstitute Serostim®, inject the diluent
into the vial of Serostim® aiming the liquid against the glass
vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved
completely. The Serostim® solution should be clear immediately
after reconstitution. DO NOT INJECT Serostim® if the reconstituted
product is cloudy immediately after reconstitution or refrigeration. Occasionally,
after refrigeration, small colorless particles may be present in the Serostim®
solution. This is not unusual for proteins like Serostim®.
STABILITY AND STORAGE
Before reconstitution: Vials of Serostim® and
diluent should be stored at room temperature (15°-30°C/59°-86°F). Expiration
dates are stated on product labels.
After reconstitution with Sterile Water for Injection, USP:
When Serostim® is reconstituted with Sterile Water for Injection,
USP, the reconstituted solution should be used immediately and any unused portion
should be discarded.
After reconstitution with Bacteriostatic Water for Injection,
USP (0.9% Benzyl Alcohol): When Serostim® is reconstituted with
Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol), the reconstituted
solution should be stored under refrigeration (2°-8°C/36°-46°F) for up to 14
days.
Avoid freezing reconstituted vials of Serostim®.
HOW SUPPLIED
Serostim® [somatropin (rDNA origin) for injection]
is available in the following forms:
Serostim® vials containing 4 mg (approximately
12 IU) somatropin (mammalian-cell) with Sterile Water for Injection, USP. Package
of 7 vials. NDC 44087-0004-7 Serostim® vials containing
5 mg (approximately 15 IU) somatropin (mammalian-cell) with Sterile Water for
Injection, USP. Package of 7 vials. NDC 44087-0005-7 Serostim®
vials containing 6 mg (approximately 18 IU) somatropin (mammalian-cell) with
Sterile Water for Injection, USP. Package of 7 vials. NDC 44087-0006-7
Serostim® vial containing 8.8 mg (approximately 26.4 IU) somatropin
(mammalian-cell) with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol).
Package of 1 vial. NDC 44087-0088-1
Manufactured for: Serono, Inc., Randolph, MA
02368, BX Rated
September 2001,AS2046-09/01
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