Medically reviewed by Drugs.com. Last updated on Mar 31, 2023.
THYMOGLOBULIN is intended for intravenous use only.
Prophylaxis of Acute Rejection
The recommended dosage of THYMOGLOBULIN for prophylaxis of acute rejection in patients receiving a kidney transplant is 1.5 mg/kg of body weight administered daily with the first dose initiated prior to reperfusion of the donor kidney. The usual duration of administration is 4 to 7 days.
Recommended Dosing Regimen
Administer the first dose of THYMOGLOBULIN over a minimum of 6 hours; administer doses on subsequent days over at least 4 hours [see Warnings and Precautions (5.3)].
Premedication with corticosteroids, acetaminophen, and/or an antihistamine 1 hour prior to each infusion of THYMOGLOBULIN is recommended and may reduce the incidence and intensity of infusion-associated reactions [see Warnings and Precautions (5.2, 5.3) and Adverse Reactions (6.1)].
Monitor patients for adverse reactions during and after infusion. Monitor total white blood cell and platelet counts during and after THYMOGLOBULIN therapy.
Reduce the THYMOGLOBULIN dose by one-half if the white blood cell (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. Consider stopping THYMOGLOBULIN treatment if the WBC count falls below 2,000 cells/mm3 or if the platelet count falls below 50,000 cells/mm3.
Recommended Concomitant Medication
THYMOGLOBULIN is used with concomitant immunosuppressants.
Administer prophylactic antifungal and antibacterial therapy if clinically indicated [see Warnings and Precautions (5.5)].
Antiviral prophylactic therapy is recommended for patients who are seropositive for cytomegalovirus (CMV) at the time of transplant and for CMV-seronegative patients scheduled to receive a kidney from a CMV-seropositive donor [see Warnings and Precautions (5.5)].
Instructions for Dilution and Administration
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).
- 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.
- 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). Discard unused portion.
- Mix the solution by inverting the bag gently only once or twice.
Administer THYMOGLOBULIN under strict medical supervision in a hospital setting, and carefully monitor patients during the infusion.
THYMOGLOBULIN is less likely to produce side effects when administered at the recommended flow rate [see Warnings and Precautions (5.3)].
- 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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