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Immunology / Rheumatoid arthritis / Methotrexate / Tofacitinib / Azathioprine / Disease-modifying antirheumatic drug / Rheumatology / Pfizer / Leflunomide / Immunosuppressants / Medicine / Pharmacology


REMS Initial REMS Approval: [removed]Most Recent Modification: [removed]NDA 203,214 XELJANZ® (TOFACITINIB)
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City

Reference / /

Company

Pfizer Inc / Pfizer Netherlands / Appendix I. Communication Plan Pfizer Inc / /

Event

Product Issues / FDA Phase / /

Facility

Laboratory Abnormalities / Health-System Pharmacy / American College of Rheumatology / Managed Care Pharmacy / /

IndustryTerm

rheumatology healthcare providers / healthcare professionals / mycophenolic acid products / communication plan / healthcare providers / /

MedicalCondition

TB / opportunistic infections / Lymphoma / active infection / herpes zoster / Lymphoproliferative Disorder / Non-melanoma skin cancers / viral and other infections / rheumatoid arthritis / Arthritis &Rheumatism / skin cancer / active tuberculosis / active TB / Virus-associated post-transplant lymphoproliferative disorder / serious infections / non-melanoma skin cancer / lymphomas / severely active rheumatoid arthritis / localized infections / infection / invasive fungal infections / viral hepatitis / solid cancers / infections / Clinical Infectious Disease / Infectious disease / serious infection / tuberculosis / /

MedicalTreatment

renal transplant / /

Organization

Congress / American Society of Health System Pharmacists / Food and Drug Administration / FDA / American College of Rheumatology / Academy of Managed Care Pharmacy / /

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Position

Chief Medical Officer / Family Physician / Dear Pharmacist / nurse / physician / Pharmacist Letter IMPORTANT DRUG WARNING Dear Pharmacist / /

Product

The XELJANZ Medication / cyclosporine / azathioprine / XELJANZ Medication / Medication Guide The Medication / XELJANZ® (TOFACITINIB) / XELJANZ / response / /

PublishedMedium

The XELJANZ Medication Guide / Annals of Internal Medicine / The Medication Guide / Annals of Emergency Medicine / American Family Physician / /

URL

www.XELJANZREMS.com / www.fda.gov/medwatch/report.htm / /

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