Natalizumab is a recombinant humanized IgG4κ monoclonal antibody, manufactured by Biogen Idec Inc. As an important biological agent, it has a unique role and clinical value in the field of multiple sclerosis treatment.

Indications for Natalizumab

Main Indications

The primary indication of Natalizumab is for the treatment of patients with relapsing multiple sclerosis to reduce the frequency of clinical relapses.

Clinical studies have shown that Natalizumab can significantly reduce the annual relapse rate in patients with multiple sclerosis.

Specifications and Characteristics of Natalizumab

Formulation Composition

Each 15mL concentrated solution contains 300mg of the active ingredient Natalizumab. Excipients include sodium chloride (123mg), a phosphate buffer system (pH 6.1), and polysorbate 80 (3mg).

The solution is a sterile, colorless to slightly opalescent concentrated solution for intravenous infusion, without preservatives.

Physicochemical Properties

It has a molecular weight of 149kDa, is produced by expression in mouse myeloma cells, and contains human-derived framework regions and mouse-derived complementarity-determining regions.

Pharmacokinetic data show that after intravenous administration of 300mg to patients, the average peak plasma concentration reaches 98±34mcg/mL, the half-life is 11±4 days, and the steady-state concentration is approximately 30mcg/mL.

Storage Method for Natalizumab

Storage Method for Unopened Drugs

The original packaged vials must be stored in a refrigerator at 2-8°C (36°-46°F), and freezing should be avoided.

It should be stored away from light, and the vials must not be shaken.

The use of drugs beyond the expiration date indicated on the package and vial labels is strictly prohibited.

Handling of Reconstituted Solution

If not used immediately, the reconstituted infusion solution can be stored at 2-8°C, but must be used within 8 hours.

The refrigerated solution needs to be brought to room temperature before use; freezing storage is also prohibited.

Reconstitution Requirements

Before use, it must be diluted with 0.9% sodium chloride injection to 100mL, and the infusion must be completed within 8 hours at room temperature.

If temporary storage of the diluted solution is required, it should be refrigerated (2-8°C), brought to room temperature before infusion, and the total storage time must not exceed 8 hours.

Infusion Precautions

The intravenous infusion time is approximately 1 hour, and the infusion line must be flushed with normal saline after completion.

Mixing with other drugs for infusion or injection through a side port is prohibited.