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.