Usual Adult Dose for Rejection Prophylaxis

Initial phase dose: 10 mg/kg IV on Day 1 (day of transplant, prior to implantation) and Day 5 (approximately 96 hours after Day 1 dose), and at the end of Weeks 2, 4, 8, and 12 after transplantation

Maintenance phase dose: 5 mg/kg IV at the end of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter

Comments:

• This drug should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.
• Dosing is based on actual body weight at the time of transplantation. The dose should not be modified during therapy unless body weight changes by more than 10%.
• The prescribed dose should be evenly divisible by 12.5 mg to allow accurate preparation of the solution (i.e., the calculated dose for a 64 kg patient: 64 kg x 10 mg per kg = 640 mg; the nearest doses to 640 mg that are evenly divisible by 12.5 mg would be 637.5 mg or 650 mg; the closest dose to the calculated dose is 637.5 mg; therefore, 637.5 should be the actual prescribed dose).

Use: In combination with basiliximab induction, mycophenolate mofetil, and corticosteroids for prophylaxis of organ rejection in EBV seropositive adult patients receiving a kidney transplant

Usual Adult Dose for Renal Transplant

Initial phase dose: 10 mg/kg IV on Day 1 (day of transplant, prior to implantation) and Day 5 (approximately 96 hours after Day 1 dose), and at the end of Weeks 2, 4, 8, and 12 after transplantation

Maintenance phase dose: 5 mg/kg IV at the end of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter

Comments:

• This drug should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.
• Dosing is based on actual body weight at the time of transplantation. The dose should not be modified during therapy unless body weight changes by more than 10%.
• The prescribed dose should be evenly divisible by 12.5 mg to allow accurate preparation of the solution (i.e., the calculated dose for a 64 kg patient: 64 kg x 10 mg per kg = 640 mg; the nearest doses to 640 mg that are evenly divisible by 12.5 mg would be 637.5 mg or 650 mg; the closest dose to the calculated dose is 637.5 mg; therefore, 637.5 should be the actual prescribed dose).

Use: In combination with basiliximab induction, mycophenolate mofetil, and corticosteroids for prophylaxis of organ rejection in EBV seropositive adult patients receiving a kidney transplant

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• There is an increased risk for developing post-transplant lymphoproliferative disorder (PTLD), involving the central nervous system (CNS). Patients without immunity to Epstein-Barr virus (EBV) are at a particular risk; therefore, use in EBV seropositive patients only. Do not use in EBV seronegative or unknown EBV serostatus patients.
• Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression.
• Only physicians experienced in immunosuppressive therapy should prescribe this drug.

CONTRAINDICATIONS:

• Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug is for IV administration only. Therapeutic monitoring is not necessary.
• Therapy should be initiated under the supervision of a specialist clinician experienced in the management of immunosuppressive therapy and renal transplant patients.
• The total infusion dose should be based on the actual body weight of the patient at the time of transplantation and should not be modified during the course of therapy unless there is a change in body weight of greater than 10%.
• The prescribed dose must be evenly divisible by 12.5 mg in order for the dose to be prepared accurately using the reconstituted solution and the silicone free disposable syringe provided.
• Patients do not need premedication prior to administration of this drug