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                           :144 000
  • %Protein binding                           :No data
  • %Excreted unchanged in urine     : No data
  • Volume of distribution (L/kg)       :No data
  • half-life – normal/ESRD (hrs)      :76.3 (after 1st infusion)/–205.8 (after 4th infusion)/–

    DOSE IN RENAL IMPAIRMENT

    GFR (mL/MIN)

  • 20 to 50     : Use with caution
  • 10 to 20     : Use with caution
  • <10           : Use with caution

    DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

  • CAPD                :Unlikely to be dialysed. Use with caution
  • HD                     :Not dialysed. Use with caution
  • HDF/high flux   :Unlikely to be dialysed. Use with caution
  • CAV/VVHD      :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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