Formulary
Natalizumab: Indications, Dosing, Side Effects and Interactions
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
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Natalizumab: Indications, Dosing, Side Effects and Interactions
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
Drug action
For all anti-lymphocyte monoclonal antibodies The anti-lymphocyte monoclonal antibodies cause lysis of B lymphocytes.
Indications and dose
**Highly active relapsing-remitting multiple sclerosis despite treatment with at least one disease-modifying drug, or those patients with rapidly-evolving severe relapsing-remitting multiple sclerosis (under expert supervision)**
- **Adult** (By Intravenous Infusion, Or By Subcutaneous Injection): 18-65 years 300 mg every 4 weeks, when switching route of administration, the new route should be used 4 weeks after the previous dose, consider discontinuing treatment if no response after 6 months.
Cautions
Cautions, further information Progressive Multifocal Leukoencephalopathy Natalizumab is associated with an increased risk of opportunistic infection and progressive multifocal leukoencephalopathy (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.
Contraindications
Active infection; active malignancies (except cutaneous basal cell carcinoma); immunosuppression; progressive multifocal leukoencephalopathy
Side effects
For all anti-lymphocyte monoclonal antibodies Common or very common Anaemia; anaphylactic reaction; arthralgia; conjunctivitis; cough; hypersensitivity (discontinue permanently); increased risk of infection; infusion related reaction; neutropenia; pain in extremity; thrombocytopenia; vomiting Uncommon Haemolytic anaemia 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). Progressive Multifocal Leukoencephalopathy (PML) If suspected, treatment should be suspended until PML has been excluded. If a patient develops an opportunistic infection or PML, anti-lymphocyte monoclonal antibodies should be permanently discontinued. Side-effects For natalizumab Common or very common Chills; dizziness; dyspnoea; fatigue; fever; flushing; headache; nausea; skin reactions Uncommon Eosinophilia; face oedema; immune reconstitution inflammatory syndrome; progressive multifocal leukoencephalopathy (PML) Rare or very rare Angioedema; hyperbilirubinaemia; nucleated red cells Frequency not known Acute retinal necrosis; basophil count increased; JC virus granule cell neuronopathy; liver injury; meningitis herpes; necrotising herpetic retinopathy Side-effects, further information 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.
Interactions
**Severe interactions:**
- Immunisations In a randomised, open label study of 60 patients with relapsing MS there was no significant difference in the humoral immune response to a recall antigen (tetanus toxoid) and only...
Pregnancy
Use only if potential benefit outweighs risk M (recommendation also supported by specialist sources-natalizumab crosses the placenta during the second and third trimesters).
Breast feeding
Specialist sources indicate present in milk but not known to be harmful. Large molecular weight suggests limited excretion into milk and drug molecule likely to be partially destroyed in the infant's gastro-intestinal tract.
Medicinal forms
Solution,Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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