Alemtuzumab Injection (Lemtrada) is an important therapeutic drug, primarily indicated for patients with specific types of multiple sclerosis. As a CD52-directed cytolytic monoclonal antibody, this medication has strict indication ranges, specific specification standards, and detailed storage requirements in clinical application.
What are the indications for Alemtuzumab Injection (Lemtrada)?
Main therapeutic scope
Alemtuzumab Injection is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), specifically including relapsing-remitting disease and active secondary progressive disease.
Usage restrictions
(1) Due to the safety profile of Alemtuzumab Injection, its use should generally be reserved for patients who have had an inadequate response to two or more MS disease-modifying therapies.
(2) It is particularly noteworthy that, because of its safety characteristics, Alemtuzumab Injection is not recommended for patients with clinically isolated syndrome (CIS).
Special precautions
(1) The use of this drug is strictly restricted, mainly due to its potential to cause serious adverse reactions such as autoimmune responses, infusion reactions, and stroke.
(2) The principle of risk-benefit assessment must be strictly followed in clinical use.
Specifications and properties of Alemtuzumab Injection (Lemtrada)
Basic specification parameters
(1) Alemtuzumab Injection is available in a strength of 12 mg/1.2 mL (10 mg/mL), packaged in single-dose vials.
(2) The drug appears as a clear, colorless to slightly yellow solution.
Physicochemical properties
(1) This injection needs to be diluted before administration by intravenous infusion.
(2) The pH value of the solution is 7.2±0.2, ensuring biocompatibility and stability.
Formulation components
Each 1 mL of the solution contains 10 mg of alemtuzumab, along with disodium hydrogen phosphate (1.15 mg), disodium edetate dihydrate (0.0187 mg), polysorbate 80 (0.1 mg), potassium chloride (0.2 mg), potassium dihydrogen phosphate (0.2 mg), sodium chloride (8 mg), and water for injection, USP.
Storage methods for Alemtuzumab Injection (Lemtrada)
Basic storage conditions
(1) Alemtuzumab Injection vials should be stored at 2°C to 8°C (36°F to 46°F).
(2) The vial stoppers are not made of natural rubber latex, ensuring drug compatibility.
Special handling requirements
(1) Freezing or shaking of the drug is strictly prohibited during storage.
(2) To maintain the stability of the drug, Alemtuzumab Injection should be kept in its original packaging box to protect it from light.
Storage after dilution
(1) The diluted Alemtuzumab Injection solution must be stored protected from light and can be kept for a maximum of 8 hours.
(2) It can be stored at room temperature (15°C to 25°C, 59°F to 77°F) or under refrigerated conditions (2°C to 8°C, 36°F to 46°F).
Transportation requirements
During transportation, it is necessary to ensure that the drug is always within the specified temperature range to avoid the impact of temperature fluctuations on drug quality.
Visual inspection requirements
(1) Before using Alemtuzumab Injection, a visual inspection for particulates and discoloration must be performed.
(2) If particulates or discoloration of the solution is observed, the drug must not be used.
