Lemtrada (Alemtuzumab Injection) is a CD52-directed cytolytic monoclonal antibody, primarily indicated for the treatment of relapsing forms of multiple sclerosis (MS). As a therapeutic drug with special risks, its use must strictly comply with prescription guidelines.
Indications for Lemtrada (Alemtuzumab Injection)
Core Therapeutic Scope
Lemtrada Injection is indicated for relapsing forms of multiple sclerosis in adults.
Relapsing-remitting multiple sclerosis (RRMS).
Active secondary progressive multiple sclerosis (active SPMS).
Usage Limitations
Second-line treatment positioning: Due to safety risks, it is usually only used in patients who have an inadequate response to two or more MS therapeutic drugs.
Not recommended for clinically isolated syndrome (CIS): Due to mismatched safety profiles.
Contraindications: Contraindicated in patients allergic to alemtuzumab or its excipients, patients with HIV infection, and patients with active infections.
Special Precautions
The drug must be obtained through the LEMTRADA REMS (Risk Evaluation and Mitigation Strategy) program to ensure full-course monitoring during medication use (e.g., monthly blood and urine tests continuing until 48 months after the last dose).
Specifications and Properties of Lemtrada (Alemtuzumab Injection)
Basic Parameters
Dosage form: Solution for intravenous injection.
Specification: 12mg/1.2mL per vial (concentration: 10mg/mL).
Appearance: Clear, colorless to slightly yellow liquid, which needs to be diluted before use.
Formulation Components
Active ingredient: Alemtuzumab (recombinant humanized IgG1 monoclonal antibody).
Excipients: Disodium hydrogen phosphate, disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, and water for injection.
Pre-Use Inspection
Visible foreign matter: Before use, check whether the solution contains particles or has changed color; if so, do not use it.
Prohibited operations: Freezing or shaking the vial is not allowed.
Storage Methods for Lemtrada (Alemtuzumab Injection)
Storage of Unopened Vials
Temperature: Store refrigerated at 2°C to 8°C (36°F to 46°F).
Light protection requirement: Keep the original packaging to prevent degradation caused by light exposure.
Prohibition of freezing: Freezing will cause protein denaturation and loss of efficacy.
Handling After Dilution
Stability: The diluted solution must be used within 8 hours and can be stored at room temperature (15-25°C) or under refrigeration (2-8°C).
Light protection: The diluted solution still needs to be protected from light and should not be directly exposed to light sources.
Transportation Requirements
Cold chain transportation is required to ensure that the temperature is controlled within the range of 2-8°C throughout the process.
