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LEMTRADA- alemtuzumab injection, solution, concentrate
Genzyme Corporation
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, AND MALIGNANCIES
LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts at periodic intervals for 48 months after the last dose of LEMTRADA [see Warnings and Precautions (5.1)].
LEMTRADA causes serious and life threatening infusion reactions. LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period [see Warnings and Precautions (5.2)].
LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams [see Warnings and Precautions (5.3)].
Because of the risk of autoimmunity, infusion reactions, and malignancies, LEMTRADA is available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) Program. Call 1-855-676-6326 to enroll in the LEMTRADA REMS program [see Warnings and Precautions (5.4)].
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Information
The recommended dosage of LEMTRADA is 12 mg/day administered by intravenous infusion for 2 treatment courses:
First Treatment Course: 12 mg/day on 5 consecutive days (60 mg total dose)
Second Treatment Course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
2.2 Vaccinations
Patients should complete any necessary immunizations at least 6 weeks prior to treatment with LEMTRADA [see Warnings and Precautions (5.9)].
Prior to LEMTRADA treatment determine whether patients have a history of varicella or have been vaccinated for varicella zoster virus (VZV). If not, test the patient for antibodies to VZV and consider vaccination for those who are antibody-negative. Postpone treatment with LEMTRADA until 6 weeks after VZV vaccination.
DOSAGE FORMS AND STRENGTHS
Injection: 12 mg/1.2 mL (10 mg/mL) in a single-use vial. LEMTRADA is a clear and colorless to slightly yellow solution that requires dilution prior to intravenous infusion.
DESCRIPTION
LEMTRADA (alemtuzumab) is a recombinant humanized IgG1 kappa monoclonal antibody directed against the cell surface glycoprotein, CD52. Alemtuzumab has an approximate molecular weight of 150kD. 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.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
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.
