Natalizumab is an important biologic agent produced by Biogen Idec. As a recombinant humanized IgG4κ monoclonal antibody, this drug has demonstrated good efficacy in the treatment of specific diseases.
Indications of Natalizumab
Core Indication Scope
The main indication of natalizumab is the treatment of relapsing forms of multiple sclerosis.
According to clinical trial data, this drug can effectively reduce the frequency of clinical relapses in patients with multiple sclerosis.
Characteristics of the Target Population
In clinical trials, natalizumab was primarily targeted at patient populations that meet the following criteria:
Having experienced at least one clinical relapse within the past year.
An Expanded Disability Status Scale (EDSS) score ranging from 0 to 5.0.
Specifications and Properties of Natalizumab
Basic Physical Properties
Natalizumab is a sterile, colorless, clear to slightly opalescent intravenous infusion concentrate.
Specification: Each 15mL dose contains 300mg of natalizumab.
Molecular weight: 149 kilodaltons.
pH value: 6.1.
Excipient Components
123mg Sodium Chloride (conforming to USP standards).
17.0mg Sodium Dihydrogen Phosphate Monohydrate (conforming to USP standards).
7.24mg Disodium Hydrogen Phosphate Heptahydrate (conforming to USP standards).
3.0mg Polysorbate 80 (conforming to USP/NF standards).
Water for Injection (conforming to USP standards).
Pharmacological Properties
Natalizumab exerts its effect by binding to the α4 subunit of α4β1 and α4β7 integrins, inhibiting the adhesion of leukocytes to their corresponding receptors, thereby preventing leukocytes from migrating to inflamed tissues.
Mean maximum serum concentration: 98±34 mcg/mL.
Mean steady-state concentration: approximately 30 mcg/mL.
Half-life: 11±4 days.
Clearance rate: 16±5 mL/hour.
Storage Methods of Natalizumab
Storage Conditions for Stock Solution
Temperature: Refrigerate at 2-8°C (36°-46°F).
Store away from light.
Freezing is prohibited.
Shaking is prohibited.
Check the expiration date before use.
Handling of Prepared Solution
Use immediately after preparation.
When stored refrigerated at 2-8°C, use within 8 hours.
Allow to warm to room temperature before use.
Freezing is prohibited.
Follow standard infusion guidelines.
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