NATALIZUMAB (TYSABRI) THERAPY IN HIGHLY ACTIVE RELAPSING MS Pt Name ___________________________ DOB ___________________________ Hosp No ___________________________ Consultant ___________________________ How to use this document This guideline will document various points in the pathway of Natalizumab administration in a patient with active MS. Each document is specific to an individual patient, will be filed in their notes, and used to supplement (not replace) standard medical & nursing records. In addition it contains information (or advice on sources) about the indications, contraindications, prescription, monitoring and follow up of patients being prescribed Natalizumab. The document starts with the decision to use Natalizumab (by one of the MS specialist neurologists), and continues through the prescription, administration, follow up etc. At each stage, certain information should be logged, or boxes ‘checked off’. Variances from this are acceptable, and expected, but reasons for this should be documented. Product Summary Natalizumab is a monoclonal antibody therapy, proven to significantly reduce relapse activity in highly active MS (by approx 70%). It is administered by IV infusion on a monthly basis. The safety data available to date suggest a maximal treatment period of two years. NB Specific information on the issues of antibody testing & PML risk is contained at the rear of this document, along with sources for further information. Eligibility for treatment with Natalizumab Patient meets criteria for ‘rapidly evolving MS’ as defined by NICE* □ Patient provided with information sheet & alert card □ GP sent copy of information sheet □ Risks of treatment discussed with patient; specifically, small risk of PML □ Consent to treatment signed & filed in notes □ Plan for natalizumab Rx agreed by second MS team consultant, and documented in notes Agreed by: Dr Young / Boggild / Wilson / Jacob (circle) □ Importance of Contraception discussed □ If Patient currently on an alternative DMT has this been discontinued? □ Estimated date first planned treatment ____________ Please copy page 1 & 2 to pharmacy (c/o WCNN Clin Trials Unit) with approx date of first planned treatment NB Contraindications include: Hypersensitivity to natalizumab or its excipients, history of PML, immunosuppression (inc prior therapies such as mitoxantrone / cyclophosphamide), current treatment with beta-interferon or glatiramer, any active malignancy. Not for use in children or adolescents. *RES-MS is defined by two or more disabling relapses in one year, and either a) significant increase in T2 weighted MRI lesion load or b) one or more enhancing lesions on MRI. This includes both treatment naive patients, and those already on a DMT. Infusion 1 Date ___________ Pregnancy test NEG □ Infusion Reaction Y/N If Yes, summarise: Patient reviewed by Consultant or SpR? □ Next Infusion Due (entry in medical notes) ___________ Infusion 2 Date Pregnancy test NEG □ Adverse events (including relapse) since last infusion? Y/N If Yes, summarise: Infusion reaction Y/N Antibody testing performed? Patient reviewed by Consultant or SpR? Next Infusion date ___________ (see appendix) □ (entry in medical notes) _______ NB/ Advice on the infusion & administration of natalizumab is held on Jefferson ward, copies in pharmacy. Drug will be prepared in pharmacy aseptics unit, not on ward. Infusion # Date Pregnancy test NEG □ Adverse events (including relapse) since last infusion? Y/N If Yes, summarise: Infusion reaction Y/N Antibody testing performed? Patient reviewed by Consultant or SpR? ___________ (see appendix) □ (entry in medical notes) Next Infusion date _______ Infusion # Date Pregnancy test NEG □ Adverse events (including relapse) since last infusion? Y/N If Yes, summarise: Infusion reaction Y/N Antibody testing performed? Patient reviewed by Consultant or SpR? Next Infusion date ___________ (see appendix) □ (entry in medical notes) _______ NB/ Advice on the infusion & administration of natalizumab is held on Jefferson ward, copies in pharmacy. Drug will be prepared in pharmacy aseptics unit, not on ward. Differentiation between MS Relapse & PML (progressive multifocal leucoencephalopathy) Nataluzimab treatment has rarely (~1:1000) been associated with PML (progressive multifocal leucoencephalopathy), a JC virus induced encephalopathy which usually follows a progressive, fatal course. Initial symptoms of PML may be confused with MS relapse/ deterioration, so a high index of suspicion is needed in patients treated with Nataluzimab. The table below summarises some key differences between symptoms of MS vs PML but if in doubt seek senior advice as soon as possible MS PML Onset • Acute • Sub-Acute Evolution • Over hours to days • Over weeks • Normally stabilize • Progressive • May resolve spontaneously Typical features • Diplopia • Behavioral and neuropsychological alteration • Paraesthesiae • Cortical signs and symptoms eg dysphasia • Paraparesis • Hemianopia • Optic neuritis • Hemiparesis • Myelopathy • Marked cerebellar findings NB/ For further information, a folder will be kept on Jefferson ward (and a further copy with Dr Wilsons’ secretary) containing Tysabri SPC (summary product characteristics), advice for reporting adverse events, flowcharts for investigation of ?PML, contact numbers for Biogen UK etc. Antibody Testing Approx 6-10% of patients will form antibodies to tysabri, which if persistent have a substantial negative effect on drug efficacy. Antibody testing should be performed if: 1) MS relapses occur 2) Infusion reactions (rigors, nausea, vomiting or flushing) occur after the initial infusion. If antibodies are +, a repeat sample should be sent in 6 weeks. Persistently + patients should discontinue treatment due to reduced efficacy If Hypersensitivity reactions occur, treatment should be discontinued irrespective of antibody status. Blood for testing should be forwarded to: Neuroimmunology Unit Room 917 Institute of Neurology Queen Square London WC1N 3BG Further Information Copies of the SPC (summary product characteristics) and booklet ‘physician information & management guidelines’ by the manufacturer Biogen-Idec, are kept in the MS Nurses Office, Jefferson ward, and Pharmacy.