Relapsing remitting multiple sclerosis (RRMS) w/ active disease defined by clinical or imaging features.
Dosage/Direction for Use
12 mg/day administered by IV infusion for 2 treatment courses. Initial treatment course 12 mg/day for 5 consecutive days. 2nd treatment course 12 mg/day for 3 consecutive days administered 12 mth after the initial treatment course.
Hypersensitivity. HIV infection.
Patients w/ inactive disease or those stable on current therapy; previous autoimmune conditions other than multiple sclerosis; ongoing thyroid disorder. Immune thrombocytopenic purpura may occur (generally between 14 & 36 mth after 1st exposure). Obtain CBC w/ differential & serum creatinine levels prior to initiation of therapy & mthly intervals thereafter until 48 mth after the last infusion. Nephropathy. Obtain thyroid function test eg, TSH levels prior to initial therapy & every 3 mth thereafter until 48 mth following the last infusion. Monitor for cytopenias by using CBC results. Infusion-associated reactions. Consider delaying initial therapy in patients w/ active infection & screening patients at high risk of HBV &/or HCV infection before initial therapy. Initiate prophylaxis w/ an oral anti-herpes agent starting on the 1st day of Lemtrada & continue for a minimum of 1 mth following each course of treatment. Concomitant use w/ antineoplastic or immunosuppresive therapies; immunomodulating therapies; live viral vaccines. Patients identified as carriers of HBV &/or HCV. Preexisting &/or an on-going malignancy. Women of child-bearing potential. Patients are recommended to have complete local immunisation requirements at least 6 wk prior to therapy. Test for antibodies to varicella zoster virus (VZV) in patients w/o a history of chickenpox or w/o vaccination against VZV. Urinalysis w/ microscopy prior to initial therapy & at mthly intervals thereafter. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn <18 yr.