Alemtuzumab Injection (Lemtrada) is a CD52-directed cytolytic monoclonal antibody indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease. Due to safety considerations, this medication should generally be reserved for patients who have had an inadequate response to two or more MS disease-modifying therapies and is not recommended for patients with clinically isolated syndrome (CIS).

Dosage and Administration, Recommended Dose of Alemtuzumab Injection (Lemtrada)

Standard Treatment Regimen

(1) The recommended dose of alemtuzumab is 12 mg per day, administered by intravenous infusion, and two or more treatment courses need to be completed.

(2) The initial treatment consists of two courses: the first course is 12 mg daily for 5 consecutive days (total dose of 60 mg).

(3) The second course is administered 12 months after the first course, at 12 mg daily for 3 consecutive days (total dose of 36 mg).

(4) After completing the second course, subsequent treatment courses may be given as needed, with each course being 12 mg daily for 3 consecutive days (total dose of 36 mg), and at least 12 months should elapse since the last dose of any previous treatment course.

(5) The specific schedule for each course is as follows: the first course is completed within 5 consecutive days, the second course is completed 12 months later, and each subsequent course is spaced at least 12 months apart.

Pre-Treatment Preparation

(1) Baseline laboratory tests must be completed and necessary immunization preparations must be made before starting treatment.

(2) Specific requirements include completing necessary immunizations at least 6 weeks before treatment.

(3) Determine whether the patient has a history of varicella or has received the varicella-zoster virus (VZV) vaccine; vaccination should be considered if antibody-negative.

(4) Perform tuberculosis screening. Instruct patients to avoid potential sources of Listeria monocytogenes.

Infusion Requirements

(1) Alemtuzumab must be diluted before administration, the infusion time should exceed 4 hours, and infusion should be initiated within 8 hours after dilution.

(2) The medication should be used in an environment equipped with appropriate equipment and personnel to manage allergic reactions or severe infusion reactions.

(3) It is prohibited to add or co-infuse other medications through the same intravenous line, and intravenous push or rapid intravenous injection is strictly forbidden.

Monitoring Requirements for Alemtuzumab Injection (Lemtrada)

Laboratory Monitoring

(1) To assess safety, laboratory tests need to be performed regularly before the start of treatment and after treatment, up to 48 months after the last alemtuzumab treatment course.

(2) Key monitoring items include: a complete blood count (CBC) with differential, which should be performed monthly before and after treatment initiation.

(3) Serum creatinine levels should be measured monthly before and after treatment initiation.

(4) Urinalysis and urine cell counts should be tested monthly before and after treatment initiation.

Specific Monitoring Indicators

(1) Baseline thyroid function testing should be performed, followed by testing every 3 months until 48 months after the last infusion.

(2) Serum transaminase and total bilirubin levels should be measured regularly before and after treatment.

(3) Baseline and annual skin examinations should be conducted to monitor for melanoma.

Medication Use in Special Populations

Pregnant Women

The use of alemtuzumab may cause harm to the fetus.

Contraception Requirements

(1) Females of reproductive potential should use effective contraception during alemtuzumab treatment and for 4 months after treatment.

(2) Before starting treatment, females of reproductive potential should be educated about the serious risks to the fetus.

Lactating Women

(1) There are no data on the presence of alemtuzumab in human milk, nor on its effects on breastfed infants or on milk production.

(2) Alemtuzumab has been detected in lactating huCD52 transgenic mice.