Relapsing-remitting & active secondary progressive multiple sclerosis (MS) in adults who had inadequate response to or are intolerant to an alternate drug.
Recommended cumulative dose: 3.5 mg/kg over 2 yr, administered as 1 treatment course of 1.75 mg/kg/yr. Each treatment course consists of 2 treatment wk, 1 at the beginning of 1st mth & 1 at the beginning of 2nd mth of the respective yr. Each treatment wk consists of 4 or 5 days on which patient receives 10 or 20 mg as single daily dose, depending on body wt. Patient ≥110 kg Treatment wk 1 & 2: 100 mg, 100 to <110 kg Treatment wk 1: 100 mg. Treatment wk 2: 90 mg, 90 to <100 kg Treatment wk 1: 90 mg. Treatment wk 2: 80 mg, 80 to <90 kg Treatment wk 1: 80 mg. Treatment wk 2: 70 mg, 70 to <80 kg Treatment wk 1 & 2: 70 mg, 60 to <70 kg Treatment wk 1 & 2: 60 mg, 50 to <60 kg Treatment wk 1 & 2: 50 mg, 40 to <50 kg Treatment wk 1 & 2: 40 mg.
May be taken with or without food: Swallow whole w/ water, do not chew. Consume immediately once removed from blister. Do not leave exposed for long period. If left on surface or broken tab is released from blister, wash the area thoroughly.
Contraindications
Hypersensitivity. HIV infection; active chronic infection eg, TB or hepatitis; active malignancy. Immunocompromised patients including those receiving immuno- or myelosuppressive therapy. Moderate or severe renal impairment (CrCl <60 mL/min). Pregnancy & lactation.
Discontinue or interrupt use if clinical signs eg, unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction develop. Not recommended in patients w/ clinically isolated syndrome. Serious, severe & opportunistic infections. Patients w/ prior malignancy; hairy cell leukaemia. Exclude HIV infection, active TB & hepatitis prior to initiation. Determine lymphocyte counts prior to initiation in yr 1 & 2; 2 & 6 mth after start of treatment in each treatment yr. Screen for latent infections eg, TB, hepatitis B & C prior to initiation in yr 1 & 2; delay initiation in patients w/ acute infection until fully controlled. Vaccination prior to initiation in patients w/ no history of varicella zoster virus exposure; postpone treatment for 4-6 wk to allow full effect of vaccination to occur. Monitor patients w/ lymphocyte counts <500 cells/mm3 for infections eg, herpes zoster. Perform baseline MRI prior to initiation (usually w/in 3 mth) & when switching from another MS drug. Assess serum aminotransferase, alkaline phosphatase & total bilirubin levels prior to initiation in yr 1 & 2. Irradiation of cellular blood components in patients requiring blood transfusion. Not recommended w/ other disease-modifying treatments for MS. Avoid vaccination w/ live or attenuated live vaccines during & after treatment. Concomitant use w/ immunomodulatory or -suppressive drugs; sorbitol-containing products & dietary intake of sorbitol. Not recommended in moderate or severe hepatic impairment (Child-Pugh score >6). May affect male fertility. Women of childbearing potential & male partners should use effective contraception during & at least 6 mth after last dose. Not to be used during lactation & for 1 wk after last dose. Childn <18 yr. Elderly >65 yr.
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