Factors Associated with Phlebitis and Venous Pain due to Intravenous Injection of Epirubicin Hydrochloride

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Abstract

Anthracyclines play an important role in the treatment of breast cancer and various regimens containing doxorubicin (A) and epirubicin hydrochloride (E), e.g., AC (doxorubicin+cyclophosphamide), EC (epirubicin hydrochloride+cyclophosphamide), and FEC (fluorouracil+epirubicin+cyclophosphamide) are widely used in clinical oncology. However, anthracyclines frequently cause inflammation or pain at the site of injection and along blood vessels. To determine the cause of phlebitis and venous pain due to these agents, we designed an experimental study to investigate factors considered to be associated with these symptoms, such as titratable acidity, osmotic pressure, and pH, for the 2 epirubicin preparations available for the FEC regimen : Farmorubicin® (freeze-dried formulation) and Farmorubicin® RTU (ready-to-use injection solution). We compared Farmorubicin® and Farmorubicin® RTU when diluted with various concentrations of saline, 5% glucose, and distilled water, and with or without dexamethasone. The titratable acidity of Farmorubicin® RTU was 3.4 mEq/L, far less than the 7 mEq/L reported to sometimes cause phlebitis and venous pain, which suggests that the titratable acidity of Farmorubicin® RTU is not connected with phlebitis or venous pain. The pHs of Farmorubicin®, Farmorubicin® RTU and dexamethasone were 4.5 to 6.0, 2.5 to 3.5, and 7.0 to 8.5, respectively. The osmotic pressures of Farmorubicin®, Farmorubicin® RTU, and dexamethasone were all 282 mOsm/kg. Thus pH could be modified by adding small amounts of dexamethasone, which is normally used prior to FEC therapy to avoid nausea, vomiting, and hypersensitivity to Farmorubicin® RTU, and doing this might prevent the phlebitis and venous pain that occur during injection of Farmorubicin® RTU.

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