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Management of Immunosuppression
Progressive Multifocal Leukoencephalopathy (PML)
Other Malignancies and Serious Infections
Liver Transplant: use in liver transplant patients is not recommended due to increased risk of graft loss and death in a clinical trial with more frequent administration of NULOJIX than studied in kidney transplant, along with MMF and corticosteroids
Immunizations: avoid use of live vaccines during NULOJIX treatment
Coadministration with Anti-Thymocyte Globulin: in de novo kidney transplant recipients, especially those with other predisposing risk factors for venous thrombosis of the renal allograft, coadministration (at the same or nearly the same time) with anti-thymocyte globulin may pose a risk for venous thrombosis of the renal allograft. If anti-thymocyte globulin (or any other cell-depleting induction treatment) and NULOJIX will be administered concomitantly, a 12-hour interval between the two administrations is suggested
Acute Rejection and Graft Loss with Corticosteroid Minimization
Pregnancy: the data with NULOJIX use in pregnant women are insufficient to inform on drug-associated risk. NULOJIX is known to cross the placenta of animals. To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX, or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the Transplant Pregnancy Registry International (TPR) by 1-877-955-6877 1-877-955-6877
Post-Transplant Lymphoproliferative Disorder (PTLD)
Management of Immunosuppression
Progressive Multifocal Leukoencephalopathy (PML)
Other Malignancies and Serious Infections
Liver Transplant: use in liver transplant patients is not recommended due to increased risk of graft loss and death in a clinical trial with more frequent administration of NULOJIX than studied in kidney transplant, along with MMF and corticosteroids
Acute Rejection and Graft Loss with Corticosteroid Minimization
Immunizations: avoid use of live vaccines during NULOJIX treatment
Coadministration with Anti-Thymocyte Globulin: in de novo kidney transplant recipients, especially those with other predisposing risk factors for venous thrombosis of the renal allograft, coadministration (at the same or nearly the same time) with anti-thymocyte globulin may pose a risk for venous thrombosis of the renal allograft. If anti-thymocyte globulin (or any other cell-depleting induction treatment) and NULOJIX will be administered concomitantly, a 12-hour interval between the two administrations is suggested
Risk of Rejection with Conversion From a Calcineurin Inhibitor (CNI) Based Maintenance Regimen: conversion of patients from a CNI based maintenance regimen increases the risk of acute rejection. Conversion of stable kidney transplant recipients from a CNI based maintenance regimen to a NULOJIX based maintenance regimen is not recommended unless the patient is CNI intolerant
Pregnancy: the data with NULOJIX use in pregnant women are insufficient to inform on drug-associated risk. NULOJIX is known to cross the placenta of animals. To monitor maternal-fetal outcomes of pregnant women who have received NULOJIX, or whose partners have received NULOJIX, healthcare providers are strongly encouraged to register pregnant patients in the Transplant Pregnancy Registry International (TPR) by calling 1-877-955-6877
Lactation: there are no data on the presence of NULOJIX in human milk or the effects on breastfed infants or human milk production to inform risk of NULOJIX to an infant during lactation. NULOJIX is excreted in rat milk and it is possible that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NULOJIX, and any potential adverse effects on the breastfed child from NULOJIX or from the underlying maternal conditions
Most Common Adverse Reactions (≥20%) through 3 years: anemia (45%), diarrhea (39%), urinary tract infection (37%), peripheral edema (34%), constipation (33%), hypertension (32%), pyrexia (28%), graft dysfunction (25%), cough (24%), nausea (24%), vomiting (22%), headache (21%), hypokalemia (21%), hyperkalemia (20%), and leukopenia (20%). No new adverse reactions were observed in the long-term extension (years 4-7) studies
Please see Full Prescribing Information, including Boxed WARNINGS.
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Bristol Myers Squibb (BMS) has ended its NULOJIX® (belatacept) Distribution Program (NDP) in the U.S. and is no longer requesting prescribing physicians to register new patients in the NDP for access to the medicine.
If you have any questions about NULOJIX®, please call 1-800-367-2783.