Drug reference
Highly active relapsing-remitting multiple sclerosis despite treatment with interferon beta or glatiramer acetate, or those patients with rapidly evolving severe relapsing-remitting multiple sclerosis (initiated under specialist supervision) ▶BY INTRAVENOUS INFUSION ▶Adult 18–65 years: 300 mg every 4 weeks, treatment should be discontinued if no response after 6 months
PDF page 926
Active infection. active malignancies (except cutaneous basal cell carcinoma). immunosuppression. progressive multifocal leucoencephalopathy
PDF page 926
Progressive Multifocal Leucoencephalopathy Natalizumab is associated with an increased risk of opportunistic infection and progressive multifocal leucoencephalopathy (PML) caused by JC virus. The risk of developing PML increases with the presence of anti-JCV antibodies, previous use of immunosuppressant therapy, and treatment duration (especially beyond 2 years of treatment); the risk beyond 4 years of treatment is not known. Patients with all three risk factors should only be treated with natalizumab if the benefits of treatment outweigh the risks. Treatment should be suspended until PML has been excluded. If a patient develops an opportunistic infection or PML, natalizumab should be permanently discontinued. For information on cautions consult product literature.
PDF page 926
Progressive Multifocal Leucoencephalopathy A magnetic resonance image (MRI) scan is recommended before starting treatment with natalizumab. Testing for serum anti-JCV antibodies before starting treatment or in those with unknown antibody status already receiving natalizumab is recommended and should be repeated every 6 months (consult product literature for full details).
PDF page 926
NICE decisions ▶Natalizumab for the treatment of adults with highly active relapsing-remitting multiple sclerosis (August 2007) NICE TA127 Natalizumab is an option for the treatment only of rapidly evolving severe relapsing-remitting multiple sclerosis (RES). RES is defined by 2 or more disabling relapses in 1 year, and 1 or more gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) or a significant increase in T2 lesion load compared with a previous MRI. Patients whose treatment was started before this guidance was published should have the option to continue treatment, until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta127 Scottish Medicines Consortium (SMC) decisions SMC No. 329/06 The Scottish Medicines Consortium has advised (September 2007) that natalizumab (Tysabri ®) is accepted for restricted use within NHS Scotland as single disease- modifying therapy in highly active relapsing-remitting multiple sclerosis only in patients with rapidly evolving severe relapsing-remitting multiple sclerosis defined by 2 or more disabling relapses in 1 year and with 1 or more gadolinium-enhancing lesions on brain magnetic resonance imaging (MRI) or a significant increase in T2 lesion load compared with a previous MRI. NHS restrictions NHS England Clinical Commissioning Policy NHS England (May 2014) has provided guidance on the use of natalizumab for the treatment of multiple sclerosis in England. An NHS England Clinical Commissioning Policy outlines the funding arrangements and the criteria for initiating and discontinuing this treatment option, see www.england.nhs.uk/commissioning/spec-services/npc-crg/ group-d/d04/.
PDF page 927
→Appendix 1: monoclonal antibodies
PDF page 926
Acute retinal necrosis. basophil count increased. eosinophilia. hyperbilirubinaemia. JC virus granule cell neuronopathy. liver injury. meningitis herpes . nucleated red cells SIDE-EFFECTS, FURTHER INFORMATION Progressive Multifocal Leukoencephalopathy (PML) If suspected, treatment should be suspended until PML has been excluded. If a patient develops an opportunistic infection or PML, natalizumab should be permanently discontinued. Liver injury Discontinue treatment if significant liver injury occurs. Infusion-related reactions Infusion-related reactions including dizziness, nausea, urticaria, chills, vomiting and flushing have been reported either during infusion or within 1 hour after completion of infusion.
PDF page 926
Avoid unless essential—toxicity in animal studies.
PDF page 926
Present in milk in animal studies—avoid.
PDF page 926
▶Monitor liver function. ▶Progressive Multifocal Leucoencephalopathy A magnetic resonance image (MRI) scan is recommended annually. Patients should be monitored for new or worsening neurological symptoms, and for cognitive and psychiatric signs of PML. All patients should continue to be monitored for signs and symptoms that may be suggestive of PML for approximately 6 months following discontinuation of treatment. ▶Hypersensitivity reactions Patients should be observed for hypersensitivity reactions, including anaphylaxis, during the infusion and for 1 hour after completion of the infusion.
PDF page 927
For intravenous infusion (Tysabri ®), give intermittently in Sodium chloride 0.9%; dilute 300 mg in 100 mL infusion fluid; gently invert to mix, do not shake. Use within 8 hours of dilution and give over 1 hour.
PDF page 927
There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ELECTROLYTES: May contain Sodium ▶Tysabri (Biogen Idec Ltd) A Natalizumab 20 mg per 1 ml Tysabri 300mg/15ml concentrate for solution for infusion vials | 1 vial P £1,130.00 (Hospital only) eiiii F 903
PDF page 927
Hypersensitivity reactions Patients should be told the importance of uninterrupted dosing, particularly in the early months of treatment (intermittent therapy may increase risk of sensitisation). Progressive Multifocal Leucoencephalopathy Patients should be informed about the risks of PML before starting treatment with natalizumab and again after 2 years; they should be given an alert card which includes information about the symptoms of PML. Liver toxicity Advise patients to seek immediate medical attention if symptoms such as jaundice or dark urine develop. Alert card A patient alert card should be provided.
PDF page 927
300 mg every 4 weeks, treatment
First-line fragment. Read the complete Indications and Dose section above.
PDF page 926
