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Transplantation medicine / Kidney transplantation / Progressive multifocal leukoencephalopathy / Mycophenolic acid / Organ transplantation / Post-transplant lymphoproliferative disorder / JC virus / Pharmacovigilance / Medicine / Organ transplants / Immunosuppressants


Initial REMS Approval: June[removed]BLA[removed]NULOJIX (belatacept) Selective T-cell costimulation blocker Bristol-Myers Squibb (BMS) Company
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Company

Bristol-Myers Squibb Company / MD Bristol-Myers Squibb / Bristol-Myers Squibb / /

Country

United States / /

Event

FDA Phase / /

Facility

American College of Clinical Pharmacy / /

/

IndustryTerm

communication plan / healthcare professionals / weakened immune systems / healthcare providers / /

MedicalCondition

CNS infection / headache / lymphoproliferative disorder / stomach-area pain vomiting / skin cancer / glands flu / serious infections / rare / serious brain infection / progressive multifocal leukoencephalopathy / diarrhea / tiredness / infections / well cough nausea / cancers / cancer / post-transplant lymphoproliferative disorder / bladder infection / fever / pain / infection / anemia / tuberculosis / /

MedicalTreatment

Liver transplant / kidney transplant / organ transplant / /

Organization

International Transplant Nurse Society / Society of Health-System Pharmacists It / American Society of Nephrology / American Society of Transplant Surgeons / Infusion Nurse Society / American Society of Health-System Pharmacists / U.S. Food and Drug Administration / American College of Clinical Pharmacy / FDA / American Society of Transplantation / National Association of Transplant Coordinators / /

Person

Laura Bessen / /

/

Position

Vice President / pharmacist / Dear Infusion Specialist / The Dear Infusion Specialist / Infusion Specialist / /

Product

sodium chloride / Medication Guide NULOJIX / For Injection / REMS ELEMENTS A. Medication / This Medication / MEDICATION GUIDE NULOJIX® / Month DD / for / 721US11REMS00101 / /

ProvinceOrState

New Jersey / /

PublishedMedium

The Medication Guide / /

Technology

Neuroscience / Transplantation / /

URL

www.NULOJIX.com.REMS.aspx / www.NULOJIX.com / www.clinicaltrials.gov / www.fda.gov/medwatch/report.htm / www.NULOJIX.com/REMS.aspx / /

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