DOSAGE AND ADMINISTRATION
The recommended dosage of Thymoglobulin for treatment of acute renal graft
rejection is 1.5 mg/kg of body weight administered daily for 7 to 14 days. The
recommended route of administration is intravenous infusion using a high-flow vein.
Thymoglobulin should be infused over a minimum of 6 hours for the first infusion and
over at least 4 hours on subsequent days of therapy.
Thymoglobulin should be administered through an in-line 0.22 micrometer
filter.
Thymoglobulin is supplied as a 10 mL vial containing lyophilized (solid)
Thymoglobulin (25 mg).
Please see
Preparation for
Administration
for vial reconstitution and dilution in infusion solution recommendations.
Investigations indicate that Thymoglobulin is less likely to produce side effects when
administered at the recommended flow rate. Administration of antiviral prophylactic
therapy is recommended. Premedication with corticosteroids, acetaminophen, and/or an
antihistamine 1 hour prior to the infusion is recommended and may reduce the incidence
and intensity of side effects during the infusion (See
PRECAUTIONS:
General
and
ADVERSE REACTIONS:
Post-Marketing Experience
). Medical personnel should monitor patients for adverse events during and
after infusion. Monitoring T-cell counts (absolute and/or subsets) to assess the level
of T-cell depletion is recommended. Total white blood cell and platelet counts should
be monitored.
Overdosage of Thymoglobulin may result in leukopenia (including lymphopenia
and neutropenia) and/or thrombocytopenia. The Thymoglobulin dose should be reduced by
one-half if the WBC count is between 2,000 and 3,000 cells/mm3 or if the
platelet count is between 50,000 and 75,000 cells/mm3. Stopping
Thymoglobulin treatment should be considered if the WBC count falls below 2,000
cells/mm3 or platelets below 50,000 cells/mm3.
Preparation for Administration
Reconstitution
After calculating the number of vials needed, using aseptic technique,
reconstitute each vial of Thymoglobulin with 5 mL of Sterile Water for Injection,
USP (SWFI). Reconstituted Thymoglobulin is physically and chemically stable for up
to 24 hours at room temperature; however, room temperature storage is not
recommended. As Thymoglobulin contains no preservatives, reconstituted product
should be used immediately.
- Allow Thymoglobulin vials to reach room temperature before reconstituting
the lyophilized product.
- Aseptically remove caps to expose rubber stoppers.
- Clean stoppers with germicidal or alcohol swab.
- Aseptically reconstitute each vial of Thymoglobulin lyophilized powder with
the 5 mL of SWFI.
- Rotate vial gently until powder is completely dissolved. Each reconstituted
vial contains 25 mg or 5 mg/mL of Thymoglobulin.
- Inspect solution for particulate matter after reconstitution. Should some
particulate matter remain, continue to gently rotate the vial until no
particulate matter is visible. If particulate matter persists, discard this
vial.
Dilution
- Transfer the contents of the calculated number of Thymoglobulin vials into
the bag of infusion solution (saline or dextrose). Recommended volume: per one
vial of Thymoglobulin use 50 mL of infusion solution (total volume usually
between 50 to 500 mL).
- Mix the solution by inverting the bag gently only once or twice.
Infusion
- Follow the manufacturer's instructions for the infusion
administration set. Infuse through a 0.22 micrometer filter into a high-flow
vein.
- Set the flow rate to deliver the dose over a minimum of 6 hours for the
first dose and over at least 4 hours for subsequent doses.
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