Natalizumab Injection 300 mg Suppliers & Bulk Manufacturers

Available Forms: IV Injection

Available Strengths: 300 mg

Reference Brands: Tysabri(US & EU)

Category: Multiple sclerosis

Natalizumab 300 mg concentrate for IV infusion, an alpha-4 integrin monoclonal antibody for relapsing multiple sclerosis, for hospital pharmacies, specialist MS centres and cold-chain distributors.

Product Description:

Natalizumab is a humanised monoclonal antibody against alpha-4 integrin on white blood cells. Blocking it stops lymphocytes sticking to vessel walls and moving into the brain and gut, where they drive inflammation. This page covers the 300 mg intravenous form, a concentrate in a single-use vial diluted into 100 mL of sodium chloride 0.9% and infused over about an hour in an infusion centre. Subcutaneous and biosimilar versions exist in some markets, so match the product to your registration.

It is used as a single disease-modifying therapy in highly active relapsing multiple sclerosis, and in the US also for selected moderate to severe Crohn's disease. The usual dose is 300 mg every four weeks. The key risk is progressive multifocal leukoencephalopathy (PML), a JC virus brain infection. Risk rises with longer use, prior immunosuppressants and a positive anti-JCV antibody result, so testing is built into care. In the US, a restricted programme governs prescribing. Hypersensitivity and herpes infections are also listed.

Sourcing notes. Natalizumab is a prescription-only biologic for specialist centres. Vials need a 2-8 °C cold chain, must not be frozen or shaken, and should travel with temperature loggers and an agreed excursion policy. Registration requires a biologic CTD dossier, with comparability data for any biosimilar. Ask for the batch CoA and release certificate, biologic GMP certificate, CoPP and pharmacovigilance arrangements. Patient alert cards and prescriber guides are often a registration condition. Give vial count, temperature needs, remaining shelf life and labelling language.