Epirubicin (epirubicin HCl)

To obtain optimum therapeutic results with minimum adverse effects, dosage of epirubicin hydrochloride must be based on the clinical, cardiac, hepatic, renal, and hematologic response and tolerance of the patient and on other chemotherapy or irradiation being used.

Epirubicin hydrochloride is administered IV. The drug is extremely irritating to tissues and, therefore, must not be given IM or subcutaneously. Care should be taken to avoid extravasation of the drug. It is recommended that solutions of the drug be administered slowly into the tubing of a freely running IV infusion of 0.9 % sodium chloride or 5% dextrose injection. Direct IV injection of epirubicin hydrochloride is not recommended because of the risk of extravasation even in the presence of adequate blood return upon needle aspiration. When possible, veins over joints or in extremities with compromised venous or lymphatic drainage should not be used. The rate of injection depends on the volume of the infusion solution and the dosage, but usually ranges from 3-20 minutes. Local erythematous streaking along the vein and/or facial flushing may be indicative of too rapid an administration rate, and may be followed by local phlebitis or thrombophlebitis.

Although a stinging or burning sensation may be a symptom of extravasation during IV administration of epirubicin hydrochloride, extravasation may occur without these symptoms and even when blood returns well during initial aspiration of the infusion needle. If any signs or symptoms of extravasation occur, the injection or infusion should be immediately stopped and restarted at another site. For information on the management of extravasation, see Dosage and Administration: Reconstitution and Administration, in Doxorubicin 10:00.

Epirubicin hydrochloride is incompatible with any alkaline pH solution; hydrolysis of the drug will occur with prolonged contact. The drug also is incompatible with heparin or fluorouracil; precipitation may occur. The manufacturer recommends that epirubicin hydrochloride not be mixed with other drugs in the same syringe.

Epirubicin hydrochloride injection and solutions of the drug must be prepared and handled cautiously by trained nonpregnant personnel, and the use of protective equipment (e.g., latex gloves) is recommended. Hands must be washed after removal of the latex gloves. Accidental contact with the skin, mucous membranes, or eyes should be treated immediately by copious lavage with water, soap and water, or sodium bicarbonate solution; abrasion of the skin by use of a scrub brush should be avoided, and prompt medical attention is necessary. Parenteral epirubicin hydrochloride solutions should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Known hypersensitivity to epirubicin, other anthracyclines, anthracenediones, or any ingredient in the formulation.

Baseline neutrophil count less than 1500/mm3; severe myocardial or hepatic impairment or recent myocardial infarction; previous anthracycline therapy up to the maximum cumulative dose.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Epirubicin hydrochloride is a toxic drug with a low therapeutic index. A therapeutic response is not likely to occur without some evidence of toxicity. The major toxic effects of the drug are on the normal, rapidly proliferating tissues, particularly those of the bone marrow, GI and oral mucosa, and hair follicles. Alopecia, nausea/vomiting, myelosuppression (leukopenia, neutropenia, anemia, thrombocytopenia), amenorrhea, mucositis, lethargy, hot flushes (flashes), diarrhea, infection, local effects (e.g., venous irritation), conjunctivitis/keratitis, rash/pruritus, skin and nail changes (e.g., hyperpigmentation) , fever, and anorexia occur commonly. Urticaria, photosensitivity, and anaphylaxis (including shock) also have occurred.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and efficacy have not been established in children; children may be at greater risk for anthracycline-induced acute manifestations of cardiotoxicity and for chronic CHF.

Category D. (See Users' Guide.)

It is unknown whether epirubicin is distributed in milk. Because other anthracyclines are distributed in milk, and because of the potential for serious adverse reactions in nursing infants from epirubicin, nursing should be discontinued prior to therapy.

Although a reduced initial dosage was not used in clinical trials in women 70 years of age and older, careful monitoring for toxicity should be employed in this age group.