Policy: Kidney/Pancreas Post Transplant: Belatacept Conversion Protocol
Statement: Statement: Vision Strategy: Patient Care
Policy Statement: The Emory Transplant Center and all the solid organ transplant programs will comply with all
applicable federal, state, and local laws, regulations, policies and protocols regarding the management of transplant
patients.
Basis: This protocol provides guidelines on the conversion of patients from a calcineurin inhibitor ( CNI ) based
regimen to a belatacept based regimen.
Admin Responsibility: All transplant program physicians, practitioners and clinical staff members are responsible
for compliance with this clinical protocol.
Activation Date: 10/6/2011
Scope/Procedure:
Protocol/Procedure:
TARGET PATIENT POPULATIONS:
CAN/CNI toxicity on biopsy
Other CNI intolerance (TMA, Tremors, H/A, NODAT)
Patients who may benefit from long-term CNI avoidance
CONVERSION CONSIDERATIONS:
1. Patients must meet standard belatacept criteria as outlined in the renal transplant primary protocol
EBV positive serology
Kidney transplant only
No history of lymphoma, PTLD, or hematologic malignancy
No history of HIV
No IV access issues
No transportation limitations
2. Patients should be on adequate immunosuppression in addition to belatacept during the
conversion period.
3. Patients at higher immunologic risk should be carefully considered prior to conversion:
Prior graft loss due to acute rejection
Recent acute rejection (within 3 months)
Banff 97 IIA or higher acute rejection
Donor specific antibodies
4. Women of child bearing potential who wish to pursue pregnancy post-transplant should be
specifically counseled on risks versus benefits regarding conversion.
5. Financial implications of conversion to belatacept for the patient should be assessed and
discussed with the patient.
STANDARD CONVERSION SCHEDULE
Baseline immunosuppression will be continued unchanged ( with the exception of the CNI
agent that is being discontinued) during the conversion.
Belatacept 5 mg/kg IV q 2 weeks x 5 doses (Day 1, 15, 29, 43, 57), then q28 days
CNI dose reduction at Day 15, discontinuation at Day 29
Day 1: Belatacept 5mg/kg IV over 30 min
Continue CNI at current dose (baseline)
Baseline labs
Provide infusion schedule and CNI withdrawal plan to patient
Day 15: Belatacept 5mg/kg IV over 30 min
Decrease CNI by 40-60% of baseline dose
Labs
Day 29: Belatacept 5mg/kg IV over 30 min
Discontinue CNI
Labs
Day 43: Belatacept 5mg/kg IV over 30 min
Labs
Day 57: Belatacept 5mg/kg IV over 30 min
Labs
Continue belatacept 5mg/kg IV every 28 days thereafter
RAPID CONVERSION SCHEDULE
Baseline immunosuppression will be continued unchanged ( with the exception of the CNI
agent that is being discontinued) during the conversion.
Consider rapid conversion in patients with evidence of TMA or acute CNI toxicity.
Belatacept 10 mg/kg IV x 1 dose (Day 1), then belatacept 5 mg/kg IV q 2 weeks x 4 doses
(Day 15, 29, 43, 57), then q 28 days
CNI dose reduction at Day 1, discontinuation at Day 15
Day 1: Belatacept 10mg/kg IV over 30 min
Decrease CNI by 40-60% of baseline dose
Baseline labs
Provide infusion schedule and CNI withdrawal plan to patient
Day 15: Belatacept 5mg/kg IV over 30 min
Discontinue CNI
Labs
Day 29: Belatacept 5mg/kg IV over 30 min
Labs
Day 43: Belatacept 5mg/kg IV over 30 min
Labs
Day 57: Belatacept 5mg/kg IV over 30 min
Labs
DOSING OF BELATACEPT FOR CONVERSION
Available as lyophilized powder 250mg vial size
Rounding doses to minimize wastage and reduce errors
Administration
Over 30 minutes via peripheral IV through a low protein binding filter
(pore size of .2-1.2 um)
Admixed doses may be stored refrigerated for up to 24hours
protected from light
Cannot be infused with other agents – no data available
REMS requirement
Medication Guide must be given to patient before EVERY infusion
Patient asked for any signs and symptoms of infection or CNS ADR’s
Pre-infusion checklist to be documented in EeMR under Clinical
Notes: Transplant Note or Transplant Nursing Note