Alemtuzumab Injection (Lemtrada) is a CD52-directed cytolytic monoclonal antibody, primarily indicated for the treatment of adult patients with relapsing multiple sclerosis.

What are the precautions for using Alemtuzumab Injection (Lemtrada)?

Risk of Autoimmune Diseases

(1) Alemtuzumab can cause severe, sometimes fatal, autoimmune diseases, such as immune thrombocytopenia and anti-glomerular basement membrane disease.

(2) Treatment may also induce other autoimmune disorders, including thyroid diseases (with an incidence rate of 36.8%), immune thrombocytopenia (2%), glomerulonephropathy (0.3%), and other autoimmune cytopenias.

(3) These risks can persist for up to 48 months after discontinuation of the drug, necessitating long-term monitoring.

Management of Infusion Reactions

(1) Alemtuzumab can cause severe and life-threatening infusion reactions, with an incidence rate of 92%.

(2) These reactions include hypersensitivity reactions (two cases of anaphylactic shock have been reported), angioedema, bronchospasm, hypotension, chest pain, and other manifestations.

(3) To reduce the risk of infusion reactions, it is recommended to administer high-dose corticosteroids for premedication immediately in the first 3 days of each treatment course.

(4) Antihistamines and/or antipyretics may be considered before alemtuzumab administration.

Requirements for Infusion Settings

(1) Alemtuzumab must be infused in a medical institution equipped with appropriate facilities and personnel to manage hypersensitivity reactions or severe infusion reactions.

(2) Patients must be observed for at least 2 hours after each infusion, as severe infusion reactions may occur after the 2-hour monitoring period.

Vaccine Management Requirements

(1) Necessary vaccinations should be completed at least 6 weeks before treatment initiation.

(2) Patients should confirm whether they have a history of varicella or have received the varicella-zoster virus (VZV) vaccine.

(3) For those who have not been vaccinated, test for VZV antibodies; vaccination should be considered for antibody-negative patients, and alemtuzumab treatment should be delayed for 6 weeks after completion of VZV vaccination.

Medication Monitoring for Alemtuzumab Injection (Lemtrada)

Regular Monitoring for 48 Months

(1) A comprehensive monitoring plan is required within 48 months after the last dose.

(2) Complete blood count (CBC) with differential, serum creatinine levels, and urinalysis must be monitored monthly.

(3) Thyroid function tests should be performed before treatment and every 3 months after treatment until 48 months following the last infusion.

Hematological System Monitoring

Specifically, CBC with differential should be conducted before the start of treatment, and then monthly until 48 months after the last infusion.

Urine Testing Requirements

(1) If the urine dipstick shows 1+ protein or higher, measure the urine protein-to-creatinine ratio.

(2) For patients with a urine protein-to-creatinine ratio exceeding 200 mg/g, a serum creatinine increase of more than 30%, or unexplained hematuria, further evaluation of nephropathy risk is required.