Long term treatment. Determine lymphocyte counts before initiation of therapy in yr 1 & 2; 2 & 6 mth after start of treatment in each treatment yr; actively monitor until values increase again if lymphocyte count is <500 cells/mm3
. Exclude HIV infection, active TB & active hepatitis before initiation of therapy. Screen for latent infections eg, TB, hepatitis B & C prior to initiation of therapy in yr 1 & 2. Consider delay in initiation of therapy in patients w/ acute infection until fully controlled. Vaccination is recommended prior to initiation of therapy in patients w/ no history of exposure to varicella zoster virus; postpone treatment for 4-6 wk to allow full effect of vaccination to occur. Consider anti-herpes prophylaxis (according to local standard practice) if lymphocyte counts drop <200 cells/mm3
, during grade 4 lymphopenia. Carefully monitor patients w/ lymphocyte counts <500 cells/mm3
for signs & symptoms suggestive of infections, in particular herpes zoster. Consider baseline MRI before initiating therapy (usually w/in 3 mth) particularly if patients are switched from other multiple sclerosis (MS) agents that have a risk of progressive multifocal leukoencephalopathy. Irradiation of cellular blood components is recommended prior to administration in patients requiring blood transfusion. MS patients w/ prior or current malignancies (w/ exception of in situ
basal or squamous cell skin cancer surgically removed w/o recurrence for at least 5 yr). Patients are advised to follow standard cancer screening guidelines. Assess serum aminotransferase, alkaline phosphatase & total bilirubin levels prior to initiation of therapy in yr 1 & 2. Consider mode of action & duration of effect of other products prior to initiation of therapy in patients previously treated w/ immunomodulating or immunosuppressive therapies. Not recommended in patients w/ fructose intolerance. Patients w/ renal impairment. Not recommended in patients w/ moderate or severe hepatic impairment (Child-Pugh score >6). Exclude pregnancy before initiation of therapy in yr 1 & 2. Women of childbearing potential must use reliable contraception during treatment & for at least 6 mth after the last dose. Women using systemically acting hormonal contraceptives should add a barrier method during treatment & for at least 4 wk after last dose in each treatment yr. Male patients must take precautions to prevent pregnancy of their partner during treatment & for at least 6 mth after last dose. Not recommended in childn <18 yr. Elderly.