Usual Adult Dose for Organ Transplant - Rejection Prophylaxis

20 mg by IV infusion over 20 to 30 minutes or by IV bolus injection within 2 hours before surgery and 4 days after transplantation; withhold the second dose if complications occur (e.g., severe hypersensitivity or graft loss)

Comments:

• This drug is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Use: For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids

Usual Pediatric Dose for Organ Transplant - Rejection Prophylaxis

One year and older:

• Weight 35 kg or less: 10 mg by IV infusion over 20 to 30 minutes or by IV bolus injection within 2 hours before surgery and 4 days after transplantation; withhold the second dose if complications occur (e.g., severe hypersensitivity or graft loss)
• Weight 35 kg or more: 20 mg by IV infusion over 20 to 30 minutes or by IV bolus injection within 2 hours before surgery and 4 days after transplantation; withhold the second dose if complications occur (e.g., severe hypersensitivity or graft loss)

Comments:

• This drug is used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Use: For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe this drug.
• The physician should have complete information for the follow-up of the patient.
• Patients receiving the drug should be managed in facilities equipped and staffed with laboratory and supportive medical resources.

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for central or peripheral IV administration only.
• The reconstituted product should be given either as a bolus injection or diluted and administered as an IV over 20 to 30 minutes.
• Bolus administration may be associated with nausea, vomiting, and local reactions (e.g., pain).
• This drug should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression.
• Patients who previously received this drug should only be re-exposed with extreme caution due to the potential risk of hypersensitivity.

Storage requirements:

• After reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2C to 8C for 24 hours or at room temperature for 4 hours.
• Discard the reconstituted solution if not used within 24 hours.

Reconstitution/preparation techniques:

• The reconstituted product should be inspected visually for particulate matter and discoloration before administration; after reconstitution, it should be a clear-to-opalescent, colorless solution. Do not use if particulate matter is present or the solution is colored.

IV compatibility:

• No incompatibility between this drug and polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of this drug with other IV substances. Other drug substances should not be added or infused simultaneously through the same IV line.

General:

• The product does not contain any antimicrobial preservatives or bacteriostatic agents.