BOXED WARNING Cardiomyopathy incl. acute LV failure (11% risk at cumulative anthracycline 450–550 mg/m2 — assess LVEF before, during, and after treatment) and serious/fatal infusion-related reactions (11% in solid tumors — withhold and resume at reduced rate; discontinue if serious/life-threatening)
FDA dosing
Population
Start
Target
Max
Ovarian cancer
Adults
IV 50 mg/m2 over 60 min q28d
Continue until progression or unacceptable toxicity
IV 50 mg/m2 q4wk (do not re-escalate after toxicity reduction)
AIDS-related Kaposi's sarcoma
Adults
IV 20 mg/m2 over 60 min q21d
Continue until progression or unacceptable toxicity
IV 20 mg/m2 q3wk
Multiple myeloma (with bortezomib)
Adults
IV 30 mg/m2 over 60 min on day 4 of each 21-day cycle, after bortezomib
8 cycles or until progression/unacceptable toxicity
IV 30 mg/m2 per cycle
Renal Undefined
Hepatic Reduce dose for serum bilirubin >=1.2 mg/dL (PK not adequately evaluated in hepatic impairment; hepatically eliminated)
Do not increase dose after a reduction for toxicity. Defined delay/25%-reduction rules for hand-foot syndrome, stomatitis, and neutropenia/thrombocytopenia (delay until ANC >=1,500 and platelets >=75,000); separate modification table when combined with bortezomib
Instructions
Do NOT substitute for other (conventional) doxorubicin HCl products
Dilute in D5W (doses <=90 mg in 250 mL; >90 mg in 500 mL); refrigerate diluted solution 2–8°C, use within 24 h
Infuse first dose at 1 mg/min; if no infusion reaction, complete over 1 h; never bolus or undiluted; no in-line filters; do not mix with other drugs; do not rapidly flush the line
Extravasation: stop infusion for burning/stinging; aspirate before removing needle, do not flush or apply pressure, ice 15 min 4x/day for 3 days, elevate extremity
Cytotoxic — follow special handling/disposal; wash skin/mucosa contact with soap and water
Contraindications
History of severe hypersensitivity reaction (incl. anaphylaxis) to doxorubicin HCl
Pregnancy Can cause fetal harm; avoid during 1st trimester; verify pregnancy status before initiating; embryotoxic/abortifacient in animals at ~0.12x clinical dose
Lactation Discontinue breastfeeding during treatment