Natalizumab | Drugs | BNF content published by NICE (2024)

Cautions, further information

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). Patients with all three risk factors should only be treated with natalizumab if the benefits of treatment outweigh the risks. Manufacturer advises treatment should be suspended until PML has been excluded. Manufacturer also advises if a patient develops an opportunistic infection or PML, natalizumab should be permanently discontinued.

For information on cautions consult product literature.

Common or very common

Abdominal pain; acne; alopecia; anaemia; anxiety; appetite decreased; arthralgia; asthenia; asthma; conjunctivitis; constipation; cough; cytokine release syndrome; depression; diarrhoea; dysphagia; ear pain; epistaxis; fever; gastrooesophageal reflux disease; headache; increased risk of infection; influenza like illness; infusion related reaction; leucopenia; lymphadenopathy; malaise; muscle complaints; muscle weakness; myocardial infarction; neutropenia; pain; pancytopenia; peripheral oedema; sensation abnormal; skin papilloma; stomatitis; sweat changes; throat irritation; thrombocytopenia; tremor; vomiting; weight decreased

Uncommon

Haemolytic anaemia; myocardial ischaemia; progressive multifocal leukoencephalopathy (PML)

Frequency not known

Liver injury

Side-effects, further information

Infusion-related side-effects

In rare cases infusion reactions may be fatal. Infusion-related side-effects occur predominantly during the first infusion. Patients should receive premedication before administration of anti-lymphocyte monoclonal antibodies to reduce these effects—consult product literature for details of individual regimens. The infusion may have to be stopped temporarily and the infusion-related effects treated—consult product literature for appropriate management.

Cytokine release syndrome

Fatalities following severe cytokine release syndrome (characterised by severe dyspnoea) and associated with features of tumour lysis syndrome have occurred after infusions of anti-lymphocyte monoclonal antibodies. Patients with a high tumour burden as well as those with pulmonary insufficiency or infiltration are at increased risk and should be monitored very closely (and a slower rate of infusion considered).

Frequency not known

Acute retinal necrosis; basophil count increased; eosinophilia; hyperbilirubinaemia; JC virus granule cell neuronopathy; 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.

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).

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.