INDICATIONS AND USAGE

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. 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.

Limitations of Use

LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

DOSAGE

Testing and Procedures Prior to Treatment

Baseline laboratory tests are required prior to treatment with LEMTRADA. In addition, prior to starting treatment with LEMTRADA:

complete any necessary immunizations at least 6 weeks prior to 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.

perform tuberculosis screening according to local guidelines.

instruct patients to avoid potential sources of Listeria monocytogenes.

Recommended Premedication and Concomitant Medication

Corticosteroids

Premedicate patients with high dose corticosteroids (1,000 mg methylprednisolone or equivalent) immediately prior to LEMTRADA infusion and for the first 3 days of each treatment course.

Herpes Prophylaxis

Administer antiviral prophylaxis for herpetic viral infections starting on the first day of each treatment course and continue for a minimum of two months following treatment with LEMTRADA or until the CD4+ lymphocyte count is at least 200 cells per microliter, whichever occurs later.

Recommended Dosage

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.

Following the second treatment course, subsequent treatment courses of 12 mg per day on 3 consecutive days (36 mg total dose) may be administered, as needed, at least 12 months after the last dose of any prior treatment courses.

Preparation Instructions

Follow the steps below to prepare the diluted solution of LEMTRADA for intravenous infusion:

Inspect LEMTRADA visually for particulate matter and discoloration prior to administration. Do not use if particulate matter is present or the solution is discolored. Do not freeze or shake vials prior to use.

Withdraw 1.2 mL of LEMTRADA from the vial into a syringe using aseptic technique and inject into a 100 mL bag of sterile 0.9% Sodium Chloride, USP or 5% Dextrose in Water, USP.

Gently invert the bag to mix the solution. Ensure the sterility of the prepared solution because it contains no antimicrobial preservatives. Each vial is for single use only.

Prior to administration, protect diluted LEMTRADA solution from light and store for as long as 8 hours either at room temperature 15°C to 25°C (59°F to 77°F) or keep refrigerated at conditions 2°C to 8°C (36°F to 46°F).

ADVERSE REACTIONS（不良反应）

Autoimmunity

Infusion Reactions

Stroke and Cervicocephalic Arterial Dissection

Malignancies

Immune Thrombocytopenia

Glomerular Nephropathies Including Anti-glomerular Basement Membrane Disease

Thyroid Disorders

Other Autoimmune Cytopenias

Autoimmune Hepatitis

Hemophagocytic Lymphohistiocytosis

Thrombotic Thrombocytopenic Purpura (TTP)

Acquired Hemophilia A

Infections

Progressive Multifocal Leukoencephalopathy (PML)

Acute Acalculous Cholecystitis

Pneumonitis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/6236b0bc-82e9-4447-9a78-f57d94770269/spl-doc?hl=Lemtrada

Lemtradainformation