Application Nr Approved Date Route Status External Links
BLA125288 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage • Nulojix Is A Selective T Cell Costimulation Blocker Indicated For Prophylaxis Of Organ Rejection In Adult Patients Receiving A Kidney Transplant. (1.1) • Use In Combination With Basiliximab Induction, Mycophenolate Mofetil, And Corticosteroids. (1.1) Limitations Of Use : • Use Only In Patients Who Are Ebv Seropositive. (1.2 , 4 , 5.1) • Use Has Not Been Established For The Prophylaxis Of Organ Rejection In Transplanted Organs Other Than The Kidney. (1.2 , 5.6) 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) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Belatacept

Comments