rituximab.txt

CLINICAL USE

Monoclonal antibody: Lymphomas Diffuse large B-cell non-Hodgkin’s lymphoma in combination with other chemotherapy
Rheumatoid arthritis Lupus nephritis (unlicensed)

DOSE IN NORMAL RENAL FUNCTION

375 mg/m 2 weekly for 4 weeksFollicular lymphoma: 375 mg/m 2 once every 3 months for up to 2 years
Rheumatoid arthritis: two 1 g doses 2 weeks apartLupus nephritis: 375 mg/m 2 for 1–2 doses, two weeks apart

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :144 000

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :No data

%Excreted unchanged in urine &nbsp &nbsp : No data

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :No data

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :76.3 (after 1st infusion)/–205.8 (after 4th infusion)/–

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 &nbsp &nbsp : Use with caution

10 to 20 &nbsp &nbsp : Use with caution

<10 &nbsp &nbsp &nbsp &nbsp &nbsp : Use with caution

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Unlikely to be dialysed. Use with caution

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Not dialysed. Use with caution

HDF/high flux &nbsp :Unlikely to be dialysed. Use with caution

CAV/VVHD &nbsp &nbsp &nbsp:Unknown dialysability. Use with caution

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

None known

ADMINISTRATION

Reconstition

–

Route

IV infusion

Rate of Administration

1st dose: 50 mg/hour, then increase the rate every 30 minutes by 50 mg/hour to achieve a maximum rate of 400 mg/hourFurther doses: 100 mg/hour, increasing by 100 mg/hour every 30 minutes to achieve a maximum rate of 400 mg/hour

Comments

Add to sodium chloride 0.9% or glucose 5% to achieve a concentration of 1–4 mg/mL, and gently invert to prevent foamingUse immediately after dilution. Infusion solution is stable for 12 hours at room temperaturePrepared solution has 24 hrs chemical stability at 2–8°C

OTHER INFORMATION

Always give a premedication of paracetamol and an antihistamine before infusionMean serum half-life increases with dose and repeated dosing (76.3 hours after 1st infusion and 205.8 hours after 4th infusion). Detectable in body for 3–6 monthsAlternative regime for vasculitis (anecdotal): 1 g/m2 on days 1 and 14, repeated at relapse or after 6 monthsPatients with high tumour burden or malignant cells >50 000 mm3 may be at risk of severe cytokine release syndrome which may be associated with acute renal failure – treat with cautionRituximab has been used to reduce alloreactive antibodies pre-transplant, to treat focal segmental glomerulosclerosis, mixed essential cryoglobulinaemia, SLE, primary systemic vasculitis, PRCA, HUS, and PTLD.

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