HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LEMTRADA safely and effectively. See full prescribing information for LEMTRADA. LEMTRADA - ® (alemtuzumab) injection ...
These highlights do not include all the information needed to use LEMTRADA safely and effectively. See full prescribing information for LEMTRADA.
LEMTRADA ® (alemtuzumab) injection, for intravenous use
Initial U.S. Approval: 2001
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, AND MALIGNANCIES
See full prescribing information for complete boxed warning.
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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 counts at periodic intervals for 48 months after the last dose. (5.1)
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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. (5.2)
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LEMTRADA may cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams. (5.3)
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LEMTRADA is available only through a restricted distribution program. (5.4)
INDICATIONS AND USAGE
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LEMTRADA is a CD52-directed cytolytic monoclonal antibody 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. (1)
DOSAGE AND ADMINISTRATION
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Administer LEMTRADA by intravenous infusion over 4 hours for 2 treatment courses:
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First course: 12 mg/day on 5 consecutive days. (2.1)
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Second course: 12 mg/day on 3 consecutive days 12 months after first treatment course. (2.1)
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Premedicate with corticosteroids prior to LEMTRADA infusion for the first 3 days of each treatment course. (2.3)
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Administer antiviral agents for herpetic prophylaxis starting on the first day of LEMTRADA dosing and continuing for a minimum of two months after completion of LEMTRADA dosing or until CD4+ lymphocyte count is more than 200 cells per microliter, whichever occurs later. (2.3)
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Must be diluted prior to administration. (2.4)
DOSAGE FORMS AND STRENGTHS
Injection: 12 mg/1.2 mL (10 mg/mL) in a single-use vial. (3)
CONTRAINDICATIONS
Infection with Human Immunodeficiency Virus. (4)
WARNINGS AND PRECAUTIONS
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Thyroid Disorders: Obtain thyroid function tests prior to initiation of treatment and every 3 months until 48 months after the last infusion. (5.7)
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Other Autoimmune Cytopenias: Monitor complete blood counts monthly until 48 months after the last infusion. (5.8)
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Consider delaying initiation of LEMTRADA in patients with active infections until the infection is fully controlled. Do not administer live viral vaccines following a course of LEMTRADA. (5.9)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 10% and > interferon beta-1a): rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Genzyme Corporation at 1-800-745-4447 (option 2) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 7/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
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