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
Xigris Indications, Dosage, Storage, Stability - Drotrecogin alfa
Xigris Indications, Dosage, Storage, Stability - Drotrecogin alfa
INDICATIONS
AND USAGE
Xigris is indicated for the reduction of mortality in adult
patients with severe sepsis (sepsis associated with acute organ dysfunction)
who have a high risk of death (e.g., as determined by APACHE II, see CLINICAL
STUDIES).
Efficacy has not been established in adult patients with severe
sepsis and lower risk of death. Safety and efficacy have not been established
in pediatric patients with severe sepsis.
DOSAGE AND ADMINISTRATION
Xigris should be administered intravenously at an infusion
rate of 24 mg/kg/hr for a total duration of infusion
of 96 hours. Dose adjustment based on clinical or laboratory parameters is not
recommended (see PRECAUTIONS).
If the infusion is interrupted, Xigris should be restarted
at the 24 mg/kg/hr infusion rate. Dose escalation
or bolus doses of Xigris are not recommended.
In the event of clinically important bleeding, immediately
stop the infusion (see WARNINGS).
Preparation and administration instructions: Use aseptic
technique.
1. Use appropriate aseptic technique during the preparation
of Xigris for intravenous administration.
2. Calculate the dose and the number of Xigris vials
needed. Each Xigris vial contains 5 mg or 20 mg of Xigris. The vial contains
an excess of Xigris to facilitate delivery of the label amount.
3. Prior to administration, 5 mg vials must be reconstituted
with 2.5 mL Sterile Water for Injection, USP, and 20 mg vials of Xigris
must be reconstituted with 10 mL of Sterile Water for Injection, USP. The
resulting concentration of the solution is approximately 2 mg/mL of Xigris.
Slowly add the Sterile Water for Injection, USP to the vial and avoid inverting
or shaking the vial. Gently swirl each vial until the powder is completely
dissolved.
4. The solution of reconstituted Xigris must be further
diluted with sterile 0.9% Sodium Chloride Injection. Slowly withdraw the
appropriate amount of reconstituted Xigris solution from the vial. Add the
reconstituted Xigris into a prepared infusion bag of sterile 0.9% Sodium
Chloride Injection. When adding the Xigris into the infusion bag, direct
the stream to the side of the bag to minimize the agitation of the solution.
Gently invert the infusion bag to obtain a homogeneous solution. Do not
transport the infusion bag between locations using mechanical delivery systems.
5. Because Xigris contains no antibacterial preservatives,
the intravenous solution should be prepared immediately upon reconstitution
of the Xigris in the vial(s). If the vial of reconstituted Xigris is not
used immediately, it may be held at controlled room temperature 15o
to 30oC (59o to 86oF), but must be used
within 3 hours. Intravenous administration must be completed within 12 hours
after the intravenous solution is prepared.
6. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration.
7. When using an intravenous infusion pump to administer
the drug, the solution of reconstituted Xigris is typically diluted into
an infusion bag containing sterile 0.9% Sodium Chloride Injection to a final
concentration of between 100 mg/mL and 200 mg/mL.
8. When using a syringe pump to administer the drug,
the solution of reconstituted Xigris is typically diluted with sterile 0.9%
Sodium Chloride Injection to a final concentration of between 100 mg/mL
and 1000 mg/mL. When administering Xigris at
low concentrations (less than approximately 200 mg/mL)
at low flow rates (less than approximately 5 mL/hr), the infusion set must
be primed for approximately 15 minutes at a flow rate of approximately 5
mL/hr.
9. Xigris should be administered via a dedicated intravenous
line or a dedicated lumen of a multilumen central venous catheter. The ONLY
other solutions that can be administered through the same line are 0.9%
Sodium Chloride Injection, Lactated Ringer’s Injection, Dextrose, or Dextrose
and Saline mixtures.
10. Avoid exposing Xigris solutions to heat and/or
direct sunlight. No incompatibilities have been observed between Xigris
and glass infusion bottles or infusion bags and syringes made of polyvinylchloride,
polyethylene, polypropylene, or polyolefin.
HOW SUPPLIED
Xigris is available in 5 mg and 20 mg single-use vials containing
sterile, preservative-free, lyophilized drotrecogin alfa (activated).
Vials:
5 mg Vials
NDC 0002-7559-01
20 mg Vials
NDC 0002-7561-01
Xigris should be stored in a refrigerator 2°
to 8°C (36° to 46°F).
Do not freeze. Protect unreconstituted vials of Xigris from light. Retain in
carton until time of use. Do not use beyond the expiration date stamped on the
vial.
REFERENCES
1. Bernard GR, et al. Efficacy and Safety of Recombinant
Human Activated Protein C for Severe Sepsis. N Engl J Med. 2001;344:699-709
2. Knaus WA, et al. APACHE II: a severity of disease
classification system. Crit Care Med. 1985;13:818-29
Literature issued November 2001
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