Natalizumab is an important biologic agent produced by Biogen Idec. As a recombinant humanized IgG4κ monoclonal antibody, this medication demonstrates favorable efficacy in the treatment of specific diseases.
Indications for Natalizumab
Core Indication Scope
The primary indication of Natalizumab is the treatment of relapsing forms of multiple sclerosis (RMS).
Based on clinical trial data, this medication can effectively reduce the frequency of clinical relapses in patients with multiple sclerosis.
Characteristics of Target Population
In clinical trials, Natalizumab was primarily targeted at patient populations meeting the following criteria:
Having experienced at least one clinical relapse within the past year.
An Expanded Disability Status Scale (EDSS) score between 0 and 5.0.
Dosage Form, Strength and Properties of Natalizumab
Basic Physical Properties
Natalizumab is a sterile, colorless, clear to slightly opalescent intravenous infusion concentrate.
Strength: Each 15mL dose contains 300mg of Natalizumab.
Molecular weight: 149 kilodaltons (kDa).
pH value: 6.1.
Excipient Composition
123mg Sodium Chloride (USP standard).
17.0mg Sodium Dihydrogen Phosphate Monohydrate (USP standard).
7.24mg Disodium Hydrogen Phosphate Heptahydrate (USP standard).
3.0mg Polysorbate 80 (USP/NF standard).
Water for Injection (USP standard).
Pharmacological Properties
Natalizumab exerts its effect by binding to the α4 subunit of α4β1 and α4β7 integrins, inhibiting the adhesion of leukocytes to corresponding receptors, thereby preventing leukocyte migration 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: 16 ± 5 mL/hour.
Storage Methods for 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 Reconstituted Solution
Use immediately after reconstitution.
Refrigerated storage at 2–8°C is allowed for no more than 8 hours.
Allow to warm to room temperature before use.
Freezing is prohibited.
Follow standard infusion guidelines.
