NULOJIX- belatacept injection, powder, lyophilized, for solution
E.R. Squibb & Sons, L.L.C.
WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS
Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus [see Contraindications (4) and Warnings and Precautions (5.1)].
Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2)].
Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression [see Warnings and Precautions (5.1, 5.3, 5.4, 5.5)].
Use in liver transplant patients is not recommended due to an increased risk of graft loss and death [see Warnings and Precautions (5.6)].
1 INDICATIONS AND USAGE
1.1 Adult Kidney Transplant Recipients
NULOJIX� (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. NULOJIX is to be used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
1.2 Limitations of Use
Use NULOJIX only in patients who are EBV seropositive [see Contraindications (4) and Warnings and Precautions (5.1)].
Use of NULOJIX for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established [see Warnings and Precautions (5.6)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Adult Kidney Transplant Recipients
NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. In clinical trials the median (25th-75th percentile) corticosteroid doses were tapered to approximately 15 mg (10-20 mg) per day by the first 6 weeks and remained at approximately 10 mg (5-10 mg) per day for the first 6 months post-transplant. Corticosteroid utilization should be consistent with the NULOJIX clinical trial experience [see Warnings and Precautions (5.7) and Clinical Studies (14.1)].
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 NULOJIX is not recommended [see Warnings and Precautions (5.1, 5.4, 5.5) and Adverse Reactions (6.1)].
NULOJIX is for intravenous infusion only. Patients do not require premedication prior to administration of NULOJIX.
Dosing instructions are provided in Table 1.
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The total infusion dose of NULOJIX 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%.
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The prescribed dose of NULOJIX 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. Evenly divisible increments are 0, 12.5, 25, 37.5, 50, 62.5, 75, 87.5, and 100. For example:
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A patient weighs 64 kg. The dose is 10 mg per kg.
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Calculated Dose: 64 kg � 10 mg per kg = 640 mg
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The closest doses evenly divisible by 12.5 mg below and above 640 mg are 637.5 mg and 650 mg.
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The nearest dose to 640 mg is 637.5 mg.
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Therefore, the actual prescribed dose for the patient should be 637.5 mg.