Usual Adult Dose for Renal Transplant

• Prophylaxis of acute rejection: 1.5 mg/kg IV daily for 4 to 7 days with the first dose initiated prior to reperfusion of the donor kidney
• Treatment of acute rejection: 1.5 mg/kg IV daily for 7 to 14 days

Comments:

• Administer this drug with concomitant immunosuppressants.
• Administer the first dose over a minimum of 6 hours; administer doses on subsequent days over at least 4 hours.
• Premedication with corticosteroids, acetaminophen, and/or an antihistamine one hour prior to each infusion is recommended to reduce the incidence and intensity of infusion-related reactions.
• Administer prophylactic antifungal and antibacterial therapy if clinically indicated. 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.
• Monitor patients for adverse reactions during and after infusion.

Use: For the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant; this drug is to be used in conjunction with concomitant immunosuppression

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

• Monitor total white blood cell and platelet counts during and after this drug.
• Reduce the dose of this drug by one-half if the white blood cell (WBC) count is between 2000 and 3000 cells/mm3 or if the platelet count is between 50,000 and 75,000 cells/mm3.
• Consider discontinuing therapy if the WBC count falls below 2000 cells/mm3 or if the platelet count falls below 50,000 cells/mm3.

Precautions

US BOXED WARNINGS:

• This drug should only be used by physicians experienced in immunosuppressive therapy in transplantation.

CONTRAINDICATIONS:

• History of allergy or anaphylactic reaction to rabbit proteins or to any product excipients
• Active acute or chronic infections that contraindicate any additional immunosuppression

Safety and efficacy have not been established in patients younger than 18 years; however, based on limited European studies and US compassionate use, the dose, efficacy, and adverse reaction profile are not thought to be different than for adults.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Infuse this drug 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.
• Administer this drug under medical supervision in a hospital setting, and monitor patients during the infusion.
• This drug is less likely to produce side effects when administered at the recommended flow rate.

Storage requirements:

• Store in refrigerator at 2C to 8C (36F to 46F).
• Protect from light.
• Do not freeze.
• Do not use after the expiration date indicated on the label.
• Reconstituted vials are physically and chemically stable for up to 24 hours at room temperature; however, room temperature storage is not recommended. Because this drug contains no preservatives, reconstituted product should be used immediately.
• Discard any unused drug.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted.

Monitoring:

• Hematologic: T-cell counts, total white blood cell, and platelet counts.
• Immunologic: Infusion-related reactions, infection.