natalizumab (Tysabri)

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[1][2][3][4][5][6][7][8][9][10][11][12][13]

Introduction

Marketing suspended for evaluation of two cases of progressive multifocal leukoencephalopathy.

Patients & prescribers must be enrolled in the Tysabri Outreach:Unified Commitment to Health (TOUCH) Prescribing program. Pharmacies must be authorized by the TOUCH Prescribing Program to dispense Tysabri.[7]

Indications

* on list of drugs to avoid for treatment of multiple sclerosis[11]

  • disproportionate adverse effects cited

Contraindications

Dosage

Monitor

Adverse effects

Laboratory

Mechanism of action

Notes

Cost = $24,000 yearly

More general terms

References

  1. ↑ Journal Watch 23(4):34, 2003 Miller DH et al, N Engl J Med 348:15, 2003 Ghoush S et al, N Engl J Med 348:24, 2003 von Andrian UH & Engelhardt B, N Engl J Med 348:68, 2003
  2. ↑ Prescriber's Letter 12(1): 2005 New Drug: Tysabri (Natalizumab) Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210109&pb=PRL (subscription needed) http://www.prescribersletter.com
  3. ↑ 3.0 3.1 Prescriber's Letter 13(2): 2006 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220215&pb=PRL (subscription needed) http://www.prescribersletter.com
  4. ↑ Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; AFFIRM Investigators. A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):899-910. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16510744
    Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; SENTINEL Investigators. Natalizumab plus interferon beta-1a for relapsing multiple sclerosis. N Engl J Med. 2006 Mar 2;354(9):911-23. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16510745
    Yousry TA, Major EO, Ryschkewitsch C, Fahle G, Fischer S, Hou J, Curfman B, Miszkiel K, Mueller-Lenke N, Sanchez E, Barkhof F, Radue EW, Jager HR, Clifford DB. Evaluation of patients treated with natalizumab for progressive multifocal leukoencephalopathy. N Engl J Med. 2006 Mar 2;354(9):924-33. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16510746
  5. ↑ 5.0 5.1 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri
  6. ↑ 6.0 6.1 6.2 FDA MedWatch http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri2
  7. ↑ 7.0 7.1 7.2 FDA MedWatch Information on Natalizumab (marketed as Tysabri) Updated Information: [9/2009] http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107198.htm
  8. ↑ 8.0 8.1 FDA MedWatch Tysabri (Natalizumab): Update of Healthcare Professional Information http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm199965.htm
  9. ↑ 9.0 9.1 9.2 FDA MedWatch Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML) Posted 01/20/2012 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm288602.htm
  10. ↑ Medical Knowledge Self Assessment Program (MKSAP) 17, 18. American College of Physicians, Philadelphia 2015, 2018.
  11. ↑ 11.0 11.1 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  12. ↑ 12.0 12.1 Campbell N et al Natalizumab Extended Interval Dosing Is Associated with a Reduction in Progressive Multifocal Leukoencephalopathy Risk in the Touch Registry. ACTRIMS Forum 2018, Feb 2 https://plan.core-apps.com/actrims2018/abstract/270ea0dccc6053d1219f9d4fc3570a3b
  13. ↑ Tysabri Outreach:Unified Commitment to Health (TOUCH) http://www.tysabri.com (800) 456-2255
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