INDICATED FOR PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS RECEIVING A KIDNEY TRANSPLANT. BELATACEPT IS TO BE USED IN COMBINATION WITH BASILIXIMAB INDUCTION, MYCOPHENOLATE MOFETIL, AND CORTICOSTEROIDS.
USE BALATACEPT ONLY IN PATIENTS WHO ARE EBV SEROPOSITIVE. USE OF BELATACEPT FOR THE PROPHYLAXIS OF ORGAN REJECTION IN TRANSPLANTED ORGANS OTHER THAN KIDNEY HAS NOT BEEN ESTABLISHED.
DUE TO AN INCREASED RISK OF POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD) PREDOMINANTLY INVOLVING THE CENTRAL NERVOUS SYSTEM (CNS), PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), AND SERIOUS CNS INFECTIONS, ADMINISTRATION OF HIGHER THAN THE RECOMMENDED DOSES OR MORE FREQUENT DOSING OF BELATACEPT IS NOT RECOMMENDED.
THE TOTAL INFUSION DOSE OF BELATACEPT 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 OF BELATACEPT MUST BE EVENLY DIVISIBLE BY 12.5 MG IN ORDER FOR THE DOSE TO BE PREPARED ACCURATELY. EVENLY DIVISIBLE INCREMENTS ARE 0, 12.5, 25, 37.5, 50, 62.5, 75, 87.5, AND 100. FOR EXAMPLE:
A PATIENT WEIGHS 64 KG. THE DOSE IS 10 MG PER KG. CALCULATED DOSE: 64 KG X10 MG PER KG = 640 MG THE CLOSEST DOSES EVENLY DIVISIBLE BY 12.5 MG BELOW AND ABOVE 640 MG ARE 637.5 MG AND 650 MG. THE NEAREST DOSE TO 640 MG IS 637.5 MG.
THEREFORE, THE ACTUAL PRESCRIBED DOSE FOR THE PATIENT SHOULD BE 637.5 MG.
DOSING FOR INITIAL PHASE:
DAY 1 (DAY OF TRANSPLANTATION, PRIOR TO IMPLANTATION) AND DAY 5 (APPROXIMATELY 96 HRS. AFTER DAY 1 DOSE) 10 MG / KG
END OF WEEK 2 AND WEEK 4 AFTER TRANSPLANTATION : 10 MG / KG
END OF WEEK 8 AND WEEK 12 AFTER TRANSPLANTATION : 10 MG / KG
DOSING FOR MAINTENANCE PHASE:
END OF WEEK 16 AFTER TRANSPLANTATION AND EVERY 4 WEEKS (PLUS OR MINUS 3 DAYS) THEREAFTER: 5 MG / KG