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
].
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
].
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
].
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NULOJIX SUMMARY
NULOJIX® (belatacept), a selective T-cell costimulation blocker, is a soluble fusion protein consisting of the modified extracellular domain of CTLA-4 fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody. Belatacept is produced by recombinant DNA technology in a mammalian cell expression system. Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4. As a result of these modifications, belatacept binds CD80 and CD86 more avidly than abatacept, the parent CTLA4-Immunoglobulin (CTLA4-Ig) molecule from which it is derived. The molecular weight of belatacept is approximately 90 kilodaltons.
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.
Limitations of Use
Use NULOJIX only in patients who are EBV seropositive [see
Contraindications (4)
and
Warnings and Precautions
].
Use of NULOJIX for the prophylaxis of organ rejection in transplanted organs other than kidney has not been established [see
Warnings and Precautions
].
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NEWS HIGHLIGHTS
Published Studies Related to Nulojix (Belatacept)
Belatacept for kidney transplant recipients. [2014]
CONCLUSIONS: There is no evidence of any difference in the effectiveness
Transcriptional profiling of belatacept and calcineurin inhibitor therapy in
renal allograft recipients. [2014]
Calcineurin inhibitor (CNI) use may lead to allograft injury and compromised
renal function. Gene expression profiles of 12-month kidney biopsies from a Phase
3 study of belatacept and a CNI comparator, cyclosporine (CsA), were compared
with expression profiles of a set of historical, demographically matched,
preimplantation control biopsies...
Prospective monitoring of cytomegalovirus, Epstein-Barr virus, BK virus, and JC
virus infections on belatacept therapy after a kidney transplant. [2014]
receiving either belatacept (n=42) or cyclosporine (n=20)... CONCLUSIONS: Epstein-Barr virus replication occurs more often in patients
Renal transplantation using belatacept without maintenance steroids or
calcineurin inhibitors. [2014]
Kidney transplantation remains limited by toxicities of calcineurin inhibitors
(CNIs) and steroids... Selected, immunologically low-risk patients can be maintained solely
on once monthly intravenous belatacept.
Belatacept-versus cyclosporine-based immunosuppression in renal transplant
recipients with pre-existing diabetes. [2011]
subpopulation with PD from previously published BENEFIT and BENEFIT-EXT trials... CONCLUSIONS: In post hoc analysis of patients with PD, patient/graft survival and
Clinical Trials Related to Nulojix (Belatacept)
Safety and Efficacy of a Steroid-free, Calcineurin Inhibitor-free, Belatacept-based Immunosuppressive Regimen [Active, not recruiting]
Transplant recipients have to take anti-rejection medications to prevent their immune system
(the body's natural defense system against illness) from rejecting their new kidney. Most
patients who get a kidney transplant must take these anti-rejection medications for the rest
of their lives, or for as long as the kidney continues to work. Taking standard
anti-rejection medications for a long time can cause serious side effects, including kidney
damage. There would be a benefit to finding new anti-rejection medications that work just as
well, but don't damage the kidney.
The purpose of this study is to find out if NULOJIX® (belatacept), will minimize serious
long term side effects seen with anti-rejection medications while still protecting your new
kidney from damage. The researchers also want to learn more about the safety of this
treatment and long term health of your transplanted kidney.
Optimization of NULOJIX� (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation [Recruiting]
Transplant recipients have to take anti-rejection medications to prevent their immune
systems (the body's natural defense system against illness) from rejecting their new organs.
Most patients who receive a transplanted organ must take these anti-rejection medications
for the rest of their lives, or for as long as the transplanted organ continues to work.
Taking standard anti-rejection medications for a long time can cause serious side effects,
including pancreas and kidney damage. There would be a benefit to finding new anti-rejection
medications that work just as well, but could lesson the amount of antirejection medications
you are taking long term.
The purpose of this study is to find out if the drug NULOJIX® (belatacept) will minimize the
amount of other antirejection medications necessary and thereby reduce the long-term side
effects caused by the other medications. The researchers also want to learn more about the
safety of this treatment and long term health of transplanted pancreases and kidneys.
Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers [Completed]
Belatacept 3 Month Post Transplant Conversion Study [Recruiting]
This study is being done to investigate the impact of changing immunosuppressive medications
from tacrolimus (Prograf®) to belatacept (Nulojix®) between three (3) and six (6) months
after kidney transplantation. The immune system is the body's defense against infection and
other disease. After transplantation, the body sees the new organ as "foreign" and tries to
destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from
attacking the transplanted organ. The primary purpose of this research study is to evaluate
the effects of three (3) different immunosuppressive treatments on rejection in
post-transplant kidney recipients. This study will test whether switching from tacrolimus to
belatacept will improve long-term kidney function.
Three of the immunosuppressants used in this study- mycophenolic acid (MPA), mycophenolate
mofetil (MMF) and tacrolimus- are medications approved by the United States Food and Drug
Administration (FDA) to be used after transplant. All of these medications have been
routinely used in kidney recipients here at Northwestern University.
Belatacept (the "study drug") has been approved by the FDA for use at the time of
transplant. However, the use of belatacept in this study is considered investigational as it
has not been FDA approved for use beginning at 3 months after transplant.
This study will involve 51 adult kidney transplant recipients at Northwestern.
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based [Recruiting]
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or
Tacrolimus to Belatacept between 6-60 months after kidney transplant.
Reports of Suspected Nulojix (Belatacept) Side Effects
Thrombocytopenia (6),
Pancytopenia (5),
Transplant Rejection (5),
Cardiac Failure Congestive (4),
Haemorrhage (3),
Renal Artery Thrombosis (3),
Death (3),
Disseminated Intravascular Coagulation (2),
Kidney Transplant Rejection (2),
Haemolytic Uraemic Syndrome (2), more >>
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Page last updated: 2015-08-10
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