Epirubicin hydrochloride

CLINICAL USE

Antineoplastic agent:Leukaemias Malignant lymphomas Multiple myeloma Various solid tumours

DOSE IN NORMAL RENAL FUNCTION

60–90 mg/m2 every 3 weeksHigh dose: 100–135 mg/m2 every 3–4 weeks,or 45 mg/m2 on days 1, 2, and 3, every 3 weeksOr according to local protocol

PHARMACOKINETICS

Molecular weight &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :580

%Protein binding &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :77

%Excreted unchanged in urine &nbsp &nbsp : 9–10

Volume of distribution (L/kg) &nbsp &nbsp &nbsp :14–38

half-life – normal/ESRD (hrs)&nbsp &nbsp &nbsp :30–40/Unchanged

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50 &nbsp &nbsp : Dose as in normal renal function

10 to 20 &nbsp &nbsp : Dose as in normal renal function

<10 &nbsp &nbsp &nbsp &nbsp &nbsp : Dose as in normal renal function, but use lower dose

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp:Unlikely to be dialysed. Dose as in normal renal function

HD &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp &nbsp :Unlikely to be dialysed. Dose as in normal renal function

HDF/high flux &nbsp :Unknown dialysability. Dose as in normal renal function

CAV/VVHD &nbsp &nbsp &nbsp:Unknown dialysability. Dose as in normal renal function

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugs

Antipsychotics: avoid concomitant use with clozapine – increased risk of agranulocytosis

Ciclosporin: increased risk of neurotoxicity

Ulcer-healing drugs: concentration reduced by cimetidine

ADMINISTRATION

Reconstition

Reconstitute with water for injection or sodium chloride 0.9% (rapid dissolution only)

Route

IV, intravesical (bladder instillation), intrathecal

Rate of Administration

IV: give via the tubing of a fast running intravenous infusion of sodium chloride 0.9% or glucose 5%, taking 3–5 minutes over the injection

IV infusion

: 30 minutes

Comments

For bladder instillation: concentration of epirubicin in bladder should be 50–80 mg per 50 mL once a week. To avoid undue dilution in urine, the patient should be instructed not to drink any fluid in the 12 hours prior to instillationIn the case of local toxicity dose is reduced to 30 mg per 50 mL

OTHER INFORMATION

A cumulative dose of 900–1000 mg/m 2 should only be exceeded with extreme caution. Above this level, the risk of irreversible congestive cardiac failure increases greatlyMainly metabolised in the liver; 27–40% eliminated by biliary excretion. Slow elimination through the liver is due to extensive tissue distribution. Urinary excretion accounts for approximately 10% of the dose in 48 hrsPatients with impaired hepatic function have prolonged and elevated plasma concentrations of epirubicin – dose reduction is requiredEpirubicin may make the urine red for 1–2 days after administration

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