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LEMTRADA
Overview
What is LEMTRADA?
LEMTRADA (alemtuzumab) is a recombinant humanized IgG1 kappa monoclonal antibody directed against the cell surface glycoprotein, CD52. Alemtuzumab has an approximate molecular weight of 150 kD. LEMTRADA is produced in mammalian cell (Chinese hamster ovary) suspension culture in a nutrient medium containing neomycin. Neomycin is not detectable in the final product. LEMTRADA is a sterile, clear and colorless to slightly yellow, solution (pH 7.2 ± 0.2) for infusion.
Each 1 mL of solution contains alemtuzumab 10 mg, dibasic sodium 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.
What does LEMTRADA look like?
What are the available doses of LEMTRADA?
Injection: 12 mg/1.2 mL (10 mg/mL) in a single-use vial. ()
What should I talk to my health care provider before I take LEMTRADA?
Pregnancy: Based on animal data, may cause fetal harm. ()
How should I use LEMTRADA?
LEMTRADA is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
The recommended dosage of LEMTRADA is 12 mg/day administered by intravenous infusion for 2 treatment courses:
What interacts with LEMTRADA?
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What are the warnings of LEMTRADA?
Sorry No Records found
What are the precautions of LEMTRADA?
Sorry No Records found
What are the side effects of LEMTRADA?
Sorry No records found
What should I look out for while using LEMTRADA?
LEMTRADA is contraindicated in patients who are infected with Human Immunodeficiency Virus (HIV) because LEMTRADA causes prolonged reductions of CD4+ lymphocyte counts.
What might happen if I take too much LEMTRADA?
Two MS patients experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia) after a single accidental infusion up to 60 mg of LEMTRADA. Doses of LEMTRADA greater than those recommended may increase the intensity and/or duration of infusion reactions or its immune effects. There is no known antidote for alemtuzumab overdosage.
How should I store and handle LEMTRADA?
Store LEMTRADA vials at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Store in original carton to protect from light. Cefazolin for injection, USP, is supplied in 10 grams Pharmacy Bulk Package.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is unknown but is presumed to involve binding to CD52, a cell surface antigen present on T and B lymphocytes, and on natural killer cells, monocytes, and macrophages. Following cell surface binding to T and B lymphocytes, alemtuzumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.
Non-Clinical Toxicology
LEMTRADA is contraindicated in patients who are infected with Human Immunodeficiency Virus (HIV) because LEMTRADA causes prolonged reductions of CD4+ lymphocyte counts.Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.
Treatment with LEMTRADA can result in the formation of autoantibodies and increase the risk of serious autoimmune mediated conditions. In clinical studies, LEMTRADA-treated patients experienced thyroid disorders (34%), immune thrombocytopenia (2%), and glomerular nephropathies (0.3%) . Autoimmune hemolytic anemia and autoimmune pancytopenia , undifferentiated connective tissue disorders, and acquired hemophilia A (anti-Factor VIII antibodies) each occurred in 0.2% of patients. Rheumatoid arthritis, type I diabetes, vitiligo, and retinal pigment epitheliopathy occurred in 0.1% of patients.
During postmarketing use, additional autoimmune events including Guillain-Barré syndrome and chronic inflammatory demyelinating polyradiculoneuropathy have been reported in the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL), as well as other disorders, generally at higher and more frequent doses than recommended in MS. An oncology patient treated with alemtuzumab had fatal transfusion-associated graft-versus-host disease.
Autoantibodies may be transferred from the mother to the fetus during pregnancy. A case of transplacental transfer of anti-thyrotropin receptor antibodies resulting in neonatal Graves' disease occurred after alemtuzumab treatment in the mother .
LEMTRADA may increase the risk of other autoimmune conditions because of the broad range of autoantibody formation with LEMTRADA.
Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals for 48 months after the last dose of LEMTRADA to allow for early detection and treatment of autoimmune adverse reactions . After 48 months, testing should be performed based on clinical findings suggestive of autoimmunity.
LEMTRADA is available only through a restricted program under a REMS .
The following serious adverse reactions are described below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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