idarubicin hydrochloride

CLINICAL USE

Antineoplastic agent:Acute non-lymphoblastic leukaemia (ANLL)2nd line for acute lymphoblastic leukaemia (ALL), breast cancer With other cytotoxic agents in combination chemotherapy regimens

DOSE IN NORMAL RENAL FUNCTION

IV: ANLL: 12 mg/m —2 daily for 3 days in combination with cytarabine, or 8 mg/m2 daily for 5 days with or without combination therapyALL: 12 mg/m —2 daily for 3 daysOral: ANLL: 30 mg/m —2 daily for 3 days as a single agent, or 15–30 mg/m2 daily for 3 days in combination with other anti-leukaemic agentsBreast cancer: 45 mg/m 2 given either as a single dose or divided over 3 consecutive days every 3–4 weeksMaximum cumulative dose is 400 mg/m 2 dailyOr see local protocol

PHARMACOKINETICS

Molecular weight                           :534

%Protein binding                           :97

%Excreted unchanged in urine     : 1–2 (4.6% as idarubicinol)

Volume of distribution (L/kg)       :64

half-life – normal/ESRD (hrs)      :10–35 (oral), 15 (IV)

DOSE IN RENAL IMPAIRMENT

GFR (mL/MIN)

20 to 50     : Use 75% of dose

10 to 20     : Use 75% of dose with caution

<10           : Use 50% of dose with caution

DOSE IN PATIENTS UNDERGOING RENAL REPLACEMENT THERAPIES

CAPD                :Not dialysed. Dose as in GFR <10 mL/min

HD                     :Not dialysed. Dose as in GFR <10 mL/min

HDF/high flux   :Unknown dialysability. Dose as in GFR <10 mL/min

CAV/VVHD      :Unknown dialysability. Dose as in GFR 10 to 20 mL/min

IMPORTANT DRUG INTERACTIONS

Potentially hazardous interactions with other drugsOther myelosuppressant medication and radiotherapy: increased risk of myelosuppression

ADMINISTRATION

Reconstition

5 mL water for injection per 5 mg

Route

IV, oral, intravesical

Rate of Administration

Give via the tubing of a fast running intravenous infusion of sodium chloride 0.9% or glucose 5%, over 5–10 minutes

Comments

Incompatible with alkaline solutions and heparinReconstituted solution is physically and chemically stable for 7 days at 2–8°C and 72 hours at room temperatureDoes not contain any antibacterial preservative so maximum recommended stability is 24 hours

OTHER INFORMATION

May cause the urine to become red for 1–2 days after administrationMetabolised to an active metabolite, idarubicinol, which has a half-life of 33–60 hours (oral), 41–69 (IV). It is eliminated by renal and hepatobiliary excretionidarubicin hydrochloride.370 IDARUbICIN HYDROCHLORIDeOral bioavailability is 18–39%, 29–58% for idarubicinol17% (IV)/8% (oral) is recovered in the faeces over 5 days and 16% (IV)/5% (oral) is recovered in the urine over 4 daysA phase II study instilled 6.25–12.5 mg of idarubicin diluted in 45 mL of sodium chloride 0.9% (0.125–0.25 mg/mL) into the bladder of patients with resected recurrent bladder cancer although it may not be any more effective than doxorubicin or epirubicin and toxicity may limit its use.

See how to identify renal failure stages according to GFR calculation

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