Lemtrada (Alemtuzumab Injection) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of relapsing multiple sclerosis (MS) in adults, including relapsing-remitting disease and active secondary progressive disease.
How to Use Lemtrada (Alemtuzumab Injection)
Standard Dosing Regimen
Alemtuzumab must be administered via intravenous infusion. The recommended dose is 12mg per day, following a treatment course model of "initial treatment + subsequent maintenance".
First treatment course: Intravenous infusion once daily for 5 consecutive days (total dose: 60mg).
Second treatment course: Intravenous infusion once daily for 3 consecutive days, 12 months after the first course (total dose: 36mg).
Subsequent treatment courses: If clinically necessary, administration may be given at least 12 months after the previous treatment, with intravenous infusion once daily for 3 consecutive days each time (total dose: 36mg).
Pretreatment Requirements
High-dose corticosteroids (1000mg methylprednisolone or equivalent) must be administered 3 days before the start of each treatment course.
Consider using antihistamines and/or antipyretics to prevent infusion reactions.
Drug Preparation
Withdraw 1.2mL (containing 12mg alemtuzumab) from a single-dose vial and inject it into 100mL of sterile 0.9% sodium chloride solution or 5% dextrose solution.
Gently invert to mix; shaking is not allowed.
After preparation, the solution can be stored protected from light at 15–25°C for no more than 8 hours, or refrigerated at 2–8°C.
Infusion Process
The infusion should last approximately 4 hours (no more than 8 hours from the completion of preparation).
The infusion must be performed under electrocardiographic (ECG) monitoring, with regular monitoring of vital signs.
Concurrent infusion with other drugs through the same intravenous access is prohibited.
Intravenous push or rapid infusion is not permitted.
Post-Infusion Observation
Observe the patient for at least 2 hours after each infusion (observation time may be extended based on clinical needs).
Inform the patient that infusion reactions may occur after the observation period and advise them to report symptoms promptly.
Dosage Adjustment of Lemtrada (Alemtuzumab Injection)
Hematological Monitoring
Perform complete blood count (CBC) with differential before treatment and monthly thereafter, continuing for 48 months after the last dose.
If immune thrombocytopenia (ITP) occurs, immediate intervention is required and discontinuation of the drug should be considered.
Renal Function Monitoring
Measure serum creatinine levels and perform urinalysis (including urine cell count) before treatment and monthly thereafter.
Further evaluation is needed if the urine protein/creatinine ratio exceeds 200mg/g.
Hepatic Function Monitoring
Assess alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin before treatment and at regular intervals.
Immediate evaluation is required if symptoms of hepatic dysfunction appear.
Thyroid Function Monitoring
Measure thyroid-stimulating hormone (TSH) levels before treatment and every 3 months thereafter, continuing for 48 months after the last dose.
Management of Infusion Reactions
Immediately stop the infusion if a severe infusion reaction occurs.
Determine whether to continue subsequent administrations based on the severity of the reaction.
Use of Lemtrada (Alemtuzumab Injection) in Special Populations
Pregnant and Lactating Women
Alemtuzumab may cause fetal harm, and cases of embryolethality have been reported.
Women of childbearing age should use effective contraception during treatment and for 4 months after the last dose.
Effects on Thyroid Function
Thyroid disease in pregnant women may increase the risk of miscarriage.
There have been cases where maternal antithyroid antibodies crossed the placenta, leading to neonatal Graves' disease.
Use During Lactation
It is unknown whether alemtuzumab is excreted into human milk.
A decision to discontinue the drug or stop breastfeeding should be made by weighing the benefits of breastfeeding against the potential risks.
Pediatric and Adolescent Patients
The efficacy of alemtuzumab in patients under 17 years of age has not been established.
Use in pediatric patients is not recommended (due to risks of autoimmunity, infusion reactions, stroke, and malignancy).
