Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15-25 0C). 

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures for proper handling and disposal of anticancer drugs should be used when handling and preparing epirubicin hydrochloride injection. Several guidelines on this subject have been published. 1-4 [see References (15)] .

Protective Measures

Take the following protective measures when handling epirubicin hydrochloride injection: 

• Train personnel in appropriate techniques for reconstitution and handling. 

• Exclude pregnant staff from working with this drug. 

• Wear protective clothing: goggles, gowns, and disposable gloves and masks when handling epirubicin hydrochloride injection. 

• Define a designated area for syringe preparation (preferably under a laminar flow system), with the work surface protected by disposable, plastic-backed, absorbent paper. 

• Place all items used for reconstitution, administration, or cleaning (including gloves) in high-risk, waste-disposal bags for high temperature incineration. 

• Treat spillage or leakage with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. Place all contaminated and cleaning materials in high-risk, waste-disposal bags for incineration. Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. Seek medical attention. Always wash hands after removing gloves. 

Incompatibilities 

Avoid prolonged contact with any solution of an alkaline pH as it will result in hydrolysis of the drug. Do not mix epirubicin hydrochloride injection with heparin or fluorouracil due to chemical incompatibility that may lead to precipitation. 

Epirubicin hydrochloride injection can be used in combination with other antitumor agents, but do not mix with other drugs in the same syringe. 

Preparation of Infusion Solution 

Administer epirubicin hydrochloride injection into the tubing of a freely flowing intravenous infusion (0.9% sodium chloride or 5% glucose solution). Patients receiving initial therapy at the recommended starting doses of 100-120 mg/m2 should generally have epirubicin hydrochloride injection infused over 15-20 minutes. For patients who require lower epirubicin hydrochloride injection starting doses due to organ dysfunction or who require modification of epirubicin hydrochloride injection doses during therapy, the epirubicin hydrochloride injection infusion time may be proportionally decreased, but should not be less than 3 minutes. This technique is intended to minimize the risk of thrombosis or perivenous extravasation, which could lead to severe cellulitis, vesication, or tissue necrosis. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein [see Warnings and Precautions (5.9)]. Use epirubicin hydrochloride injection within 24 hours of first penetration of the rubber stopper. Discard any unused solution.