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BELATACEPT

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Overview

What is NULOJIX?

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.

NULOJIX is supplied as a sterile, white or off-white lyophilized powder for intravenous administration. Prior to use, the lyophile is reconstituted with a suitable fluid to obtain a clear to slightly opalescent, colorless to pale yellow solution, with a pH in the range of 7.2 to 7.8. Suitable fluids for constitution of the lyophile include SWFI, 0.9% NS, or D5W . Each 250 mg single-use vial of NULOJIX also contains: monobasic sodium phosphate (34.5 mg), sodium chloride (5.8 mg), and sucrose (500 mg).



What does NULOJIX look like?



What are the available doses of NULOJIX?

Lyophilized powder for injection: 250 mg per vial

What should I talk to my health care provider before I take NULOJIX?

How should I use NULOJIX?

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.

NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids. In clinical trials the median (25 to 75 percentile) corticosteroid doses were tapered to approximately 15 mg (10 to 20 mg) per day by the first 6 weeks and remained at approximately 10 mg (5 to 10 mg) per day for the first 6 months post-transplant. Corticosteroid utilization should be consistent with the NULOJIX clinical trial experience .

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 .

NULOJIX is for intravenous infusion only. Patients do not require premedication prior to administration of NULOJIX.

Dosing instructions are provided in Table 1.


What interacts with NULOJIX?

Sorry No Records found


What are the warnings of NULOJIX?

Sorry No Records found


What are the precautions of NULOJIX?

Sorry No Records found


What are the side effects of NULOJIX?

Sorry No records found


What should I look out for while using NULOJIX?

NULOJIX is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) .


What might happen if I take too much NULOJIX?

Single doses up to 20 mg per kg of NULOJIX have been administered to healthy subjects without apparent toxic effect. The administration of NULOJIX of higher cumulative dose and more frequent dosing than recommended in kidney transplant patients resulted in a higher frequency of CNS-related adverse reactions . In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.


How should I store and handle NULOJIX?

TALTZ is sterile and preservative-free. Discard any unused portion. NULOJIX (belatacept) lyophilized powder for intravenous infusion is supplied as a single-use vial with a in the following packaging configuration: