Ofatumumab Injection 20 mg/0.4 mL (50 mg/mL) Suppliers & Bulk Manufacturers

Available Forms: Injection(SQ)

Available Strengths: 20 mg/0.4 mL (50 mg/mL)

Reference Brands: Kesimpta(US)

Category: Multiple sclerosis

Ofatumumab subcutaneous injection, an anti-CD20 monoclonal antibody for relapsing multiple sclerosis, in single-use prefilled pens or syringes. For hospital pharmacies, neurology services and cold-chain importers.

Product Description:

Ofatumumab is a fully human IgG1 monoclonal antibody that binds CD20 on B lymphocytes and depletes them. In multiple sclerosis a low monthly subcutaneous dose is enough to keep B-cell counts down. The standard presentation is 20 mg in 0.4 mL, that is 50 mg/mL, in a single-use prefilled pen or syringe. Patients inject at home after training. It differs from the older intravenous ofatumumab for leukaemia, which used far higher doses.

Ofatumumab is licensed for relapsing forms of multiple sclerosis in adults. Treatment starts with 20 mg at weeks 0, 1 and 2, then 20 mg monthly from week 4. Patients are screened for hepatitis B first, since B-cell depletion can reactivate it, and immunoglobulin levels are checked. Injection-related reactions are most common with the first dose. Infections, including rare progressive multifocal leukoencephalopathy, need watching. Live vaccines are avoided during treatment, and other vaccines should be completed before starting.

Sourcing notes. Ofatumumab is a biological medicine, so registration rests on a full biologics dossier, and any non-originator product would be assessed as a biosimilar. It needs a cold chain: store at 2-8 °C in the carton to protect from light, and do not freeze. The short room-temperature allowance on the label is for patients, not for transport. Ask for temperature logger data per shipment, a CoA and batch release certificate per lot, a biologics GMP certificate and a CoPP. It is prescription-only. State pen or syringe, quantity, remaining shelf life and market.